Vaccine Therapy and GM-CSF With or Without Low-Dose Aldesleukin in Treating Patients With Stage II, Stage III, or Stage IV Melanoma
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 2/21/2019 |
| Start Date: | March 2007 |
| End Date: | January 2, 2013 |
Melanoma Peptide Vaccines (MART1 Analog, gp100 and Survivin) With GM-CSF and Low-Dose IL-2 as Immune Adjuvants, A Pilot Study
RATIONALE: Vaccines made from peptides may help the body build an effective immune response
to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of
immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white
blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in
incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy
together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with
stage II, stage III, or stage IV melanoma.
to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of
immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white
blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in
incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy
together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with
stage II, stage III, or stage IV melanoma.
OBJECTIVES:
- Determine the safety and toxicity profile of peptide vaccine comprising MART-1 antigen,
gp100 antigen, and survivin antigen in combination with sargramostim (GM-CSF) emulsified
in incomplete Freund's adjuvant (IFA) with or without low-dose aldesleukin in patients
with stage II-IV melanoma.
- Determine the immunologic effects of two different doses of GM-CSF coemulsified with
melanoma peptides in IFA in these patients.
- Determine the immunological effects of low-dose aldesleukin therapy administered after
peptide immunization in these patients.
- Collect preliminary data on the impact of the vaccine on clinical outcomes in these
patients.
OUTLINE: This is a pilot study. Patients are stratified according to disease stage (II vs III
or IV). Patients are sequentially enrolled into 1 of 4 different dose schedules.
- Dose schedule 1: Patients receive gp100 antigen, MART-1 antigen, survivin antigen, and
sargramostim (GM-CSF) emulsified in incomplete Freund's adjuvant (peptide vaccine)
subcutaneously (SC) on day 1. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity.
- Dose schedule 2: Patients receive peptide vaccine as in group 1. Patients also receive
low-dose aldesleukin SC twice daily on days 7-20. Treatment repeats every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity.
- Dose schedule 3: Patients receive peptide vaccine as in group 1 except with a higher
dose of GM-CSF. Treatment repeats every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity.
- Dose schedule 4: Patients receive peptide vaccine as in group 1 except with a higher
dose of GM-CSF. Patients also receive low-dose aldesleukin SC twice daily on days 7-20.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity.
Cohorts of 5 patients receive treatment at subsequent dose schedule until the maximum
tolerated dose schedule (MTDS) is determined. The MTDS is defined as the dose schedule
preceding that at which 2 of 5 patients experience dose-limiting toxicity within the first
course.
After completion of study therapy, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
- Determine the safety and toxicity profile of peptide vaccine comprising MART-1 antigen,
gp100 antigen, and survivin antigen in combination with sargramostim (GM-CSF) emulsified
in incomplete Freund's adjuvant (IFA) with or without low-dose aldesleukin in patients
with stage II-IV melanoma.
- Determine the immunologic effects of two different doses of GM-CSF coemulsified with
melanoma peptides in IFA in these patients.
- Determine the immunological effects of low-dose aldesleukin therapy administered after
peptide immunization in these patients.
- Collect preliminary data on the impact of the vaccine on clinical outcomes in these
patients.
OUTLINE: This is a pilot study. Patients are stratified according to disease stage (II vs III
or IV). Patients are sequentially enrolled into 1 of 4 different dose schedules.
- Dose schedule 1: Patients receive gp100 antigen, MART-1 antigen, survivin antigen, and
sargramostim (GM-CSF) emulsified in incomplete Freund's adjuvant (peptide vaccine)
subcutaneously (SC) on day 1. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity.
- Dose schedule 2: Patients receive peptide vaccine as in group 1. Patients also receive
low-dose aldesleukin SC twice daily on days 7-20. Treatment repeats every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity.
- Dose schedule 3: Patients receive peptide vaccine as in group 1 except with a higher
dose of GM-CSF. Treatment repeats every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity.
- Dose schedule 4: Patients receive peptide vaccine as in group 1 except with a higher
dose of GM-CSF. Patients also receive low-dose aldesleukin SC twice daily on days 7-20.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity.
Cohorts of 5 patients receive treatment at subsequent dose schedule until the maximum
tolerated dose schedule (MTDS) is determined. The MTDS is defined as the dose schedule
preceding that at which 2 of 5 patients experience dose-limiting toxicity within the first
course.
After completion of study therapy, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma
- Stage II-IV disease
- Completely resected disease
- No known standard therapy that is potentially curative or proven capable of extending
life expectancy exists
- HLA-A2 positive
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,500/mm³
- Hemoglobin > 10 g/dL
- Platelet count ≥ 50,000/mm³
- AST ≤ 3 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled or current infection
- No known allergy to vaccine or immunoadjuvant components
- No known immune deficiency
PRIOR CONCURRENT THERAPY:
- No chemotherapy within the past 4 weeks and recovered
- No biologic therapy within the past 4 weeks
- No radiation therapy within the past 4 weeks
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