• Percent changes in peptide vaccine-specific immune responses (tetramer frequencies) from pretreatment levels [ Designated as safety issue: No ]
• Number and severity of hematologic and nonhematologic toxicities observed at each dose level [ Designated as safety issue: Yes ]

• Percent changes in peptide vaccine-specific immune responses (tetramer frequencies) from pretreatment levels
• Number and severity of hematologic and nonhematologic toxicities observed at each dose level

• Delayed-type hypersensitivity positivity [ Designated as safety issue: No ]
• Maximum percent change in CD4, CD8, CD14, CD19, and C20 levels from preimmunization levels [ Designated as safety issue: No ]
• Time to treatment failure [ Designated as safety issue: No ]
• Time to progression [ Designated as safety issue: No ]

• Delayed-type hypersensitivity positivity
• Maximum percent change from preimmunization levels of CD4, CD8, CD14, CD19, and C20
• Time to treatment failure
• Time to progression

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.

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.

• Biological: MART-1 antigen
• Biological: aldesleukin
• Biological: gp100 antigen
• Biological: incomplete Freund's adjuvant
• Biological: sargramostim
• Biological: survivin antigen

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