Trial Outcomes & Findings for CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer (NCT NCT01218867)

NCT ID: NCT01218867

Last Updated: 2019-12-10

Results Overview

Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

5 years

Results posted on

2019-12-10

Participant Flow

Twenty-four participants were enrolled but one participant was not treated due to a new cancer diagnosis which made the participant ineligible for this protocol.

Participant milestones

Participant milestones
Measure
Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) cluster of differentiation 8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Overall Study
STARTED
1
1
3
1
1
1
4
3
3
4
2
Overall Study
COMPLETED
1
1
3
1
1
1
3
3
3
4
2
Overall Study
NOT COMPLETED
0
0
0
0
0
0
1
0
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) cluster of differentiation 8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Overall Study
Death during treatment
0
0
0
0
0
0
1
0
0
0
0

Baseline Characteristics

CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)
n=1 Participants
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)
n=4 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)
n=4 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)
n=2 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Total
n=24 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=10 Participants
4 Participants
n=115 Participants
3 Participants
n=6 Participants
3 Participants
n=6 Participants
4 Participants
n=64 Participants
2 Participants
n=17 Participants
23 Participants
n=21 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
1 Participants
n=21 Participants
Age, Continuous
61.0 years
STANDARD_DEVIATION 0 • n=5 Participants
51.0 years
STANDARD_DEVIATION 0 • n=7 Participants
52.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
65.0 years
STANDARD_DEVIATION 0 • n=4 Participants
55.0 years
STANDARD_DEVIATION 0 • n=21 Participants
35.0 years
STANDARD_DEVIATION 0 • n=10 Participants
45.5 years
STANDARD_DEVIATION 11.3 • n=115 Participants
37.0 years
STANDARD_DEVIATION 18.0 • n=6 Participants
54.7 years
STANDARD_DEVIATION 11.9 • n=6 Participants
46.3 years
STANDARD_DEVIATION 5.6 • n=64 Participants
41.5 years
STANDARD_DEVIATION 10.6 • n=17 Participants
47.9 years
STANDARD_DEVIATION 11.8 • n=21 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
1 Participants
n=115 Participants
1 Participants
n=6 Participants
1 Participants
n=6 Participants
2 Participants
n=64 Participants
0 Participants
n=17 Participants
7 Participants
n=21 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=10 Participants
3 Participants
n=115 Participants
2 Participants
n=6 Participants
2 Participants
n=6 Participants
2 Participants
n=64 Participants
2 Participants
n=17 Participants
17 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
1 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
2 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
4 Participants
n=115 Participants
3 Participants
n=6 Participants
2 Participants
n=6 Participants
4 Participants
n=64 Participants
2 Participants
n=17 Participants
22 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
White
1 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
3 Participants
n=115 Participants
2 Participants
n=6 Participants
3 Participants
n=6 Participants
4 Participants
n=64 Participants
1 Participants
n=17 Participants
20 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=10 Participants
1 Participants
n=115 Participants
1 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
1 Participants
n=17 Participants
4 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
Region of Enrollment
United States
1 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=10 Participants
4 Participants
n=115 Participants
3 Participants
n=6 Participants
3 Participants
n=6 Participants
4 Participants
n=64 Participants
2 Participants
n=17 Participants
24 Participants
n=21 Participants

PRIMARY outcome

Timeframe: 5 years

Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.

Outcome measures

Outcome measures
Measure
Cohort 1 - 1x10(6) Cells (High Dose IL-2)
n=1 Participants
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 2 - 3x10(6) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 3 - 1x10(7) Cells (High Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 4 - 3x10(7) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 5 - 1x10(8) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 6 - 3x10(8) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 7 - 1x10(9) Cells (High Dose IL-2)
n=4 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 8 - 1x10(9) Cells (Low Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 9 - 3x10(9) Cells (Low Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 10 - 1x10(10) Cells (Low Dose IL-2)
n=4 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 11 - 3x10(10) Cells (Low Dose IL-2)
n=2 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Number of Participants With a Response to Therapy
Complete Response (CR)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With a Response to Therapy
Partial Response (PR)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With a Response to Therapy
Stable Disease (SD)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With a Response to Therapy
Progressive Disease (PD)
1 Participants
1 Participants
3 Participants
1 Participants
1 Participants
1 Participants
3 Participants
3 Participants
3 Participants
3 Participants
2 Participants

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately, 33 months and 25 days

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure
Cohort 1 - 1x10(6) Cells (High Dose IL-2)
n=1 Participants
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 2 - 3x10(6) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 3 - 1x10(7) Cells (High Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 4 - 3x10(7) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 5 - 1x10(8) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 6 - 3x10(8) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 7 - 1x10(9) Cells (High Dose IL-2)
n=4 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 8 - 1x10(9) Cells (Low Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 9 - 3x10(9) Cells (Low Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 10 - 1x10(10) Cells (Low Dose IL-2)
n=4 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 11 - 3x10(10) Cells (Low Dose IL-2)
n=2 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Number of Participants With Serious and Non-Serious Adverse Events
1 Participants
1 Participants
3 Participants
1 Participants
1 Participants
1 Participants
4 Participants
3 Participants
3 Participants
3 Participants
2 Participants

SECONDARY outcome

Timeframe: 6 years

Population: This outcome measure was not done due to the lack of a minimum number (e.g. 4) of required durable responses in the participants. A durable response is defined as a complete response, partial response, or stable disease in at least 4 participants.

Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR) will be used to augment polymerase chain reaction (PCR)-based analysis. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1 (1x10(6) Cells (High Dose IL-2)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Cohort 2 (3x10(6) Cells (High Dose IL-2)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Cohort 3 (1x10(7) Cells (High Dose IL-2)

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort 4 (3x10(7) Cells (High Dose IL-2)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Cohort 5 (1x10(8) Cells (High Dose IL-2)

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Cohort 6 (1x10(8) Cells (High Dose IL-2)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Cohort 7 (1x10(9) Cells (High Dose IL-2)

Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths

Cohort 8 (1x10(9) Cells (Low Dose IL-2)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort 9 (3x10(9) Cells (Low Dose IL-2)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort 10 (1x10(10) Cells (Low Dose IL-2)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort 11 (3x10(10) Cells (Low Dose IL-2)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Cohort 1 (1x10(6) Cells (High Dose IL-2)
n=1 participants at risk
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 2 (3x10(6) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 3 (1x10(7) Cells (High Dose IL-2)
n=3 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 4 (3x10(7) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 5 (1x10(8) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 6 (1x10(8) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 7 (1x10(9) Cells (High Dose IL-2)
n=4 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 8 (1x10(9) Cells (Low Dose IL-2)
n=3 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 9 (3x10(9) Cells (Low Dose IL-2)
n=3 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 10 (1x10(10) Cells (Low Dose IL-2)
n=4 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 11 (3x10(10) Cells (Low Dose IL-2)
n=2 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Gastrointestinal disorders
Nausea
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Gastrointestinal disorders
Vomiting
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
General disorders
Pain
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Infections and infestations
Infection
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days

Other adverse events

Other adverse events
Measure
Cohort 1 (1x10(6) Cells (High Dose IL-2)
n=1 participants at risk
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 2 (3x10(6) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 3 (1x10(7) Cells (High Dose IL-2)
n=3 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 4 (3x10(7) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 5 (1x10(8) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 6 (1x10(8) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 7 (1x10(9) Cells (High Dose IL-2)
n=4 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 8 (1x10(9) Cells (Low Dose IL-2)
n=3 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 9 (3x10(9) Cells (Low Dose IL-2)
n=3 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 10 (1x10(10) Cells (Low Dose IL-2)
n=4 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Cohort 11 (3x10(10) Cells (Low Dose IL-2)
n=2 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
Metabolism and nutrition disorders
Creatinine
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Blood and lymphatic system disorders
Hemoglobin
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Blood and lymphatic system disorders
Leukocytes (Total WBC)
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
4/4 • Number of events 4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Blood and lymphatic system disorders
Lymphopenia
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
4/4 • Number of events 4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
4/4 • Number of events 4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Blood and lymphatic system disorders
Platelets
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
4/4 • Number of events 4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Cardiac disorders
Supraventricular and nodal arrhythmia
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Infections and infestations
Infection
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Blood and lymphatic system disorders
PTT (Partial Thromboplstin Time)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
General disorders
Fatigue (asthenia, lethargy, malaise)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Cardiac disorders
Hypotension
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Infections and infestations
Febrile neutropenia
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Nervous system disorders
Confusion
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Gastrointestinal disorders
Dehydration
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Gastrointestinal disorders
Nausea
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Metabolism and nutrition disorders
Alkaline phosphatase
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Nervous system disorders
Psychosis (hallucinations/delusions)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Ear and labyrinth disorders
Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Gastrointestinal disorders
Constipation
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Renal and urinary disorders
Hemorrhage, GU
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Nervous system disorders
Somnolence/depressed level of consciousness
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Eye disorders
Ocular/Visual-Other (vision changes)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
General disorders
Pain
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Renal and urinary disorders
Renal failure
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
General disorders
Syndromes - Other (hemaphogocytic syndrome)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Vascular disorders
Acute vascular leak syndrome
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Nervous system disorders
Syncope (fainting)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
Renal and urinary disorders
Renal/Genitourinary - Other (low urine output)
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days

Additional Information

Dr. Steven Rosenberg

National Cancer Institute

Phone: 301- 496-4164

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place