Trial Outcomes & Findings for Anti-MART-1 F5 Lymphocytes to Treat High-Risk Melanoma Patients (NCT NCT00706992)
NCT ID: NCT00706992
Last Updated: 2015-10-28
Results Overview
Percentage of participants with an immunologic response of \>20 spots/100,000 cells measured by IFN gamma secretion using enzyme linked immunosorbent spot (ELISPOT) assay. This was done using ELISPOT assay which measures immune response at the single cell level.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
9/24/08-10/9/12
Results posted on
2015-10-28
Participant Flow
Participant milestones
| Measure |
Arm I - Adj-4 A2 F5 Cells
Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
|
Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
|
Arm III - Adj-4 A2 F5 Cells + SQ IL-2
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
|
Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
|
Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine
Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
|
Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2
Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
|
Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine
Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
9
|
8
|
6
|
5
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
6
|
2
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
6
|
2
|
4
|
2
|
3
|
Reasons for withdrawal
| Measure |
Arm I - Adj-4 A2 F5 Cells
Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
|
Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
|
Arm III - Adj-4 A2 F5 Cells + SQ IL-2
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
|
Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
|
Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine
Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
|
Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2
Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
|
Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine
Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Study termination
|
5
|
5
|
6
|
2
|
3
|
2
|
3
|
|
Overall Study
Disease progression before treatment
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Anti-MART-1 F5 Lymphocytes to Treat High-Risk Melanoma Patients
Baseline characteristics by cohort
| Measure |
Arm I
n=8 Participants
Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
|
Arm II
n=8 Participants
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
|
Arm III
n=9 Participants
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
|
Arm IV
n=8 Participants
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
|
Arm V
n=6 Participants
Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
|
Arm VI
n=5 Participants
Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
|
Arm VII
n=6 Participants
Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
|
Total
n=50 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
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
50 Participants
n=6 Participants
|
|
Age, Categorical
>=65 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
|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
49.2 years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
49.0 years
STANDARD_DEVIATION 11.2 • n=10 Participants
|
39.2 years
STANDARD_DEVIATION 5.7 • n=115 Participants
|
47.2 years
STANDARD_DEVIATION 10.4 • n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
20 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
30 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 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
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
49 Participants
n=6 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
|
|
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
|
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
48 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 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
|
1 Participants
n=6 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
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
6 participants
n=21 Participants
|
5 participants
n=10 Participants
|
6 participants
n=115 Participants
|
50 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 9/24/08-10/9/12Population: Arms 1-6 were evaluated in patients who received F5 cells. Arm 7 was not included in the evaluation because the participants did not receive F5 cells.The immunological response was measured for the total percentage of pts whom specimen was available for analysis. This was not captured per Arm. No statistically significant responses were observed.
Percentage of participants with an immunologic response of \>20 spots/100,000 cells measured by IFN gamma secretion using enzyme linked immunosorbent spot (ELISPOT) assay. This was done using ELISPOT assay which measures immune response at the single cell level.
Outcome measures
| Measure |
Arm I - 6
n=40 Participants
Arm I - Adj-4 A2 F5 cells Arm II-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide Arm III-Adj-4 A2 F5 cells + SQ IL-2 Arm IV-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide+SQ IL-2 Arm V-Adj-4 A2 F5 cells + ALVAC MART-1:26-35(27L) Vaccine Arm VI-Adj-4 A2 F5 cells + ALVAC MART-1 Vaccine + SQ IL-2
|
Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
|
Arm III - Adj-4 A2 F5 Cells + SQ IL-2
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
|
Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
|
Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine
Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
|
Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2
Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
|
Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine
Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Immunologic Response
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 yearsHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Arm I - 6
n=8 Participants
Arm I - Adj-4 A2 F5 cells Arm II-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide Arm III-Adj-4 A2 F5 cells + SQ IL-2 Arm IV-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide+SQ IL-2 Arm V-Adj-4 A2 F5 cells + ALVAC MART-1:26-35(27L) Vaccine Arm VI-Adj-4 A2 F5 cells + ALVAC MART-1 Vaccine + SQ IL-2
|
Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide
n=8 Participants
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
|
Arm III - Adj-4 A2 F5 Cells + SQ IL-2
n=9 Participants
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
|
Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2
n=8 Participants
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
|
Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine
n=6 Participants
Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
|
Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2
n=5 Participants
Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
|
Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine
n=6 Participants
Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
8 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
Adverse Events
Arm I
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm II
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm III
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm IV
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm V
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm VI
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm VII
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I
n=8 participants at risk
Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
|
Arm II
n=8 participants at risk
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
|
Arm III
n=9 participants at risk
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
|
Arm IV
n=8 participants at risk
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
|
Arm V
n=6 participants at risk
Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
|
Arm VI
n=5 participants at risk
Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
|
Arm VII
n=6 participants at risk
Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10\^6.4 to 10\^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Hemoglobin
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
87.5%
7/8 • Number of events 7
|
12.5%
1/8 • Number of events 1
|
77.8%
7/9 • Number of events 7
|
62.5%
5/8 • Number of events 5
|
66.7%
4/6 • Number of events 4
|
60.0%
3/5 • Number of events 3
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Eye disorders
OCULAR/VISUAL:: Ocular/Visual-Other, left conjunctivitis (inflammation)
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Pain - Other, body aches
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
55.6%
5/9 • Number of events 5
|
87.5%
7/8 • Number of events 7
|
0.00%
0/6
|
100.0%
5/5 • Number of events 5
|
0.00%
0/6
|
|
General disorders
Rigors/chills
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
0.00%
0/8
|
75.0%
6/8 • Number of events 6
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
16.7%
1/6 • Number of events 2
|
|
General disorders
Pain
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
25.0%
2/8 • Number of events 4
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
0.00%
0/8
|
0.00%
0/8
|
22.2%
2/9 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutropenia
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/8
|
0.00%
0/8
|
22.2%
2/9 • Number of events 2
|
50.0%
4/8 • Number of events 4
|
0.00%
0/6
|
60.0%
3/5 • Number of events 3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.00%
0/8
|
0.00%
0/8
|
22.2%
2/9 • Number of events 2
|
62.5%
5/8 • Number of events 5
|
0.00%
0/6
|
60.0%
3/5 • Number of events 3
|
0.00%
0/6
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Eye disorders
OCULAR/VISUAL:: Ocular/Visual-Other (Specify)
|
0.00%
0/8
|
0.00%
0/8
|
22.2%
2/9 • Number of events 2
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Pain - Other, body pain
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrointestinal - Other, sigmoid diverticulosis (incidental finding on CT scan)
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Eye disorders
OCULAR/VISUAL:: Ocular/Visual-Other, vision changes
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Eye disorders
Uveitis
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
|
Cardiac disorders
Hypotension
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/6
|
40.0%
2/5 • Number of events 2
|
0.00%
0/6
|
Additional Information
Dr. Steven Rosenberg
National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place