Trial Outcomes & Findings for Anti-MART-1 F5 Cells Plus ALVAC MART-1 Vaccine to Treat Advanced Melanoma (NCT NCT00612222)
NCT ID: NCT00612222
Last Updated: 2015-10-28
Results Overview
Clinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met
Results posted on
2015-10-28
Participant Flow
Four participants were enrolled in this study.
Participant milestones
| Measure |
ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2
ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10\^7 CCID50 (with a range of approximately 10\^6,4 to 10\^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10\^7 CCID50/2 mL). This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-MART-1 F5 Cells Plus ALVAC MART-1 Vaccine to Treat Advanced Melanoma
Baseline characteristics by cohort
| Measure |
ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2
n=4 Participants
ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10\^7 CCID50 (with a range of approximately 10\^6,4 to 10\^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10\^7 CCID50/2 mL). This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are metClinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module.
Outcome measures
| Measure |
ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2
n=4 Participants
ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10\^7 CCID50 (with a range of approximately 10\^6,4 to 10\^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10\^7 CCID50/2 mL). This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days.
|
|---|---|
|
Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: This outcome measure was not done because the study was terminated due to low accrual.
T cell receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 monthsHere is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2
n=4 Participants
ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10\^7 CCID50 (with a range of approximately 10\^6,4 to 10\^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10\^7 CCID50/2 mL). This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days.
|
|---|---|
|
Number of Participants With Adverse Events
|
4 Participants
|
Adverse Events
ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2
n=4 participants at risk
ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10\^7 CCID50 (with a range of approximately 10\^6,4 to 10\^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10\^7 CCID50/2 mL). This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days.
|
|---|---|
|
Ear and labyrinth disorders
Hearing test abnormal
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Eye disorders
Uveitis
|
25.0%
1/4 • Number of events 1 • 15 months
|
Other adverse events
| Measure |
ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2
n=4 participants at risk
ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10\^7 CCID50 (with a range of approximately 10\^6,4 to 10\^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10\^7 CCID50/2 mL). This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days.
|
|---|---|
|
Ear and labyrinth disorders
Hearing test abnormal
|
25.0%
1/4 • Number of events 2 • 15 months
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
100.0%
4/4 • Number of events 4 • 15 months
|
|
Blood and lymphatic system disorders
Leukocyte count decreased
|
100.0%
4/4 • Number of events 4 • 15 months
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
100.0%
4/4 • Number of events 6 • 15 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
100.0%
4/4 • Number of events 4 • 15 months
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
100.0%
4/4 • Number of events 4 • 15 months
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Investigations
Activated partial thromboplastin time prolonged (aPTT)
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
50.0%
2/4 • Number of events 2 • 15 months
|
|
Infections and infestations
Febrile neutropenia
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Infections and infestations
Catheter-related infection
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
50.0%
2/4 • Number of events 2 • 15 months
|
|
Metabolism and nutrition disorders
Bilirubin increased
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
50.0%
2/4 • Number of events 2 • 15 months
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Nervous system disorders
Confusion
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Nervous system disorders
Psychosis
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Speech disorder
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
75.0%
3/4 • Number of events 3 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Number of events 1 • 15 months
|
|
Vascular disorders
Thrombosis
|
25.0%
1/4 • Number of events 1 • 15 months
|
Additional Information
Steven A. Rosenberg, M.D.
National Cancer Institute (NCI), National Institutes of Health (NIH)
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place