Trial Outcomes & Findings for Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Ocular Melanoma (NCT NCT01814046)
NCT ID: NCT01814046
Last Updated: 2018-10-11
Results Overview
Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
approximately 3 years
Results posted on
2018-10-11
Participant Flow
Patients experiencing a sustained stable disease, partial or complete response may receive a second treatment when progression by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria is documented after evaluation by the principal investigator. Retreatment will consist of the same regimen that they had been given safely previously.
Participant milestones
| Measure |
Cells + High Dose Aldesleukin
Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
Cells and no High Dose Aldesleukin
Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
Cells + High-Dose Aldesleukin Retreatment
Patients experiencing a sustained stable disease, partial or complete response may receive a second treatment when progression by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria is documented after evaluation by the principal investigator. Retreatment will consist of the same regimen that they had been given safely previously.
|
|---|---|---|---|
|
Drug Administration
STARTED
|
22
|
2
|
0
|
|
Drug Administration
COMPLETED
|
21
|
2
|
0
|
|
Drug Administration
NOT COMPLETED
|
1
|
0
|
0
|
|
Retreatment
STARTED
|
0
|
0
|
3
|
|
Retreatment
COMPLETED
|
0
|
0
|
3
|
|
Retreatment
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cells + High Dose Aldesleukin
Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
Cells and no High Dose Aldesleukin
Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
Cells + High-Dose Aldesleukin Retreatment
Patients experiencing a sustained stable disease, partial or complete response may receive a second treatment when progression by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria is documented after evaluation by the principal investigator. Retreatment will consist of the same regimen that they had been given safely previously.
|
|---|---|---|---|
|
Drug Administration
Death due to complications of RSV
|
1
|
0
|
0
|
Baseline Characteristics
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Ocular Melanoma
Baseline characteristics by cohort
| Measure |
Cells + High Dose Aldesleukin
n=22 Participants
Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
Cells and no High Dose Aldesleukin
n=2 Participants
Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
64 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
57.85 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 3 yearsObjective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Cells + High Dose Aldesleukin
n=22 Participants
Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
Cells and no High Dose Aldesleukin
n=2 Participants
Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
|---|---|---|
|
Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR))
Complete Response (CR)
|
4.54 percentage of participants
Interval 0.0 to 22.8
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR))
Partial Response (PR)
|
31.81 percentage of participants
Interval 13.9 to 54.9
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 46 months and 12 daysHere is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in 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
| Measure |
Cells + High Dose Aldesleukin
n=22 Participants
Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
Cells and no High Dose Aldesleukin
n=2 Participants
Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
|---|---|---|
|
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)
|
22 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks (+/- 2 weeks)Population: One out of 24 subjects had blurred vision.
Visual symptoms (e.g., blurred) were evaluated and if changes had occurred from baseline, i.e. in visual acuity, an ophthalmologic consult was performed.
Outcome measures
| Measure |
Cells + High Dose Aldesleukin
n=22 Participants
Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
Cells and no High Dose Aldesleukin
n=2 Participants
Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
|---|---|---|
|
Count of Participants With Changes in Visual Symptoms
|
1 Participants
|
0 Participants
|
Adverse Events
Cells + High-Dose Aldesleukin
Serious events: 1 serious events
Other events: 22 other events
Deaths: 1 deaths
Cells and No High-Dose Aldesleukin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cells + High-Dose Aldesleukin Retreatment
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cells + High-Dose Aldesleukin
n=22 participants at risk
Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
Cells and No High-Dose Aldesleukin
n=2 participants at risk
Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
Cells + High-Dose Aldesleukin Retreatment
n=3 participants at risk
Patients experiencing a sustained stable disease, partial or complete response may receive a second treatment when progression by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria is documented after evaluation by the principal investigator. Retreatment will consist of the same regimen that they had been given safely previously.
|
|---|---|---|---|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
General disorders
Death not associated with CTCAE term::Multi-organ failure
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
0.00%
0/22 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
33.3%
1/3 • Number of events 1 • 46 months and 12 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Nervous system disorders
Neuropathy: motor
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/22 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
66.7%
2/3 • Number of events 2 • 46 months and 12 days
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/22 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
33.3%
1/3 • Number of events 1 • 46 months and 12 days
|
Other adverse events
| Measure |
Cells + High-Dose Aldesleukin
n=22 participants at risk
Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
Cells and No High-Dose Aldesleukin
n=2 participants at risk
Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
|
Cells + High-Dose Aldesleukin Retreatment
n=3 participants at risk
Patients experiencing a sustained stable disease, partial or complete response may receive a second treatment when progression by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria is documented after evaluation by the principal investigator. Retreatment will consist of the same regimen that they had been given safely previously.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
50.0%
1/2 • Number of events 1 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
13.6%
3/22 • Number of events 3 • 46 months and 12 days
|
50.0%
1/2 • Number of events 1 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
9.1%
2/22 • Number of events 2 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
9.1%
2/22 • Number of events 2 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
13.6%
3/22 • Number of events 3 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
33.3%
1/3 • Number of events 1 • 46 months and 12 days
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify, cardiac arrhythmia)
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Metabolism and nutrition disorders
Creatinine
|
31.8%
7/22 • Number of events 7 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
27.3%
6/22 • Number of events 6 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Blood and lymphatic system disorders
Edema: viscera
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
22.7%
5/22 • Number of events 5 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
66.7%
2/3 • Number of events 2 • 46 months and 12 days
|
|
Infections and infestations
Febrile neutropenia
|
27.3%
6/22 • Number of events 6 • 46 months and 12 days
|
50.0%
1/2 • Number of events 1 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Blood and lymphatic system disorders
Hemoglobin
|
63.6%
14/22 • Number of events 14 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
66.7%
2/3 • Number of events 2 • 46 months and 12 days
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Cardiac disorders
Hypotension
|
9.1%
2/22 • Number of events 2 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
27.3%
6/22 • Number of events 7 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
33.3%
1/3 • Number of events 1 • 46 months and 12 days
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
54.5%
12/22 • Number of events 12 • 46 months and 12 days
|
50.0%
1/2 • Number of events 1 • 46 months and 12 days
|
66.7%
2/3 • Number of events 2 • 46 months and 12 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
22/22 • Number of events 23 • 46 months and 12 days
|
100.0%
2/2 • Number of events 2 • 46 months and 12 days
|
100.0%
3/3 • Number of events 3 • 46 months and 12 days
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
22/22 • Number of events 22 • 46 months and 12 days
|
100.0%
2/2 • Number of events 2 • 46 months and 12 days
|
33.3%
1/3 • Number of events 1 • 46 months and 12 days
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
9.1%
2/22 • Number of events 2 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
9.1%
2/22 • Number of events 2 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
33.3%
1/3 • Number of events 2 • 46 months and 12 days
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
22/22 • Number of events 22 • 46 months and 12 days
|
100.0%
2/2 • Number of events 2 • 46 months and 12 days
|
66.7%
2/3 • Number of events 2 • 46 months and 12 days
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
50.0%
1/2 • Number of events 1 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Renal and urinary disorders
Renal failure
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, decrease urine output)
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, oliguriat)
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
33.3%
1/3 • Number of events 1 • 46 months and 12 days
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Atrial fibrillation
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
|
Eye disorders
Vision-blurred vision
|
4.5%
1/22 • Number of events 1 • 46 months and 12 days
|
0.00%
0/2 • 46 months and 12 days
|
0.00%
0/3 • 46 months and 12 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place