• Toxicity of treatment by NCI Common Toxicity Criteria after each course of treatment [ Designated as safety issue: Yes ]
• Disease-free and progression-free survival comparison by disease evaluation every 3 months after treatment [ Designated as safety issue: No ]
• Immunologic response to treatment by various laboratory studies before and after each course of treatment [ Designated as safety issue: No ]
• Quality of life by Functional Assessment of Chronic Illness Therapy Fatigue Subscale RSF-36 SDS before and after the first course of treatment [ Designated as safety issue: No ]

• Toxicity of treatment by NCI Common Toxicity Criteria after each course of treatment
• Disease-free and progression-free survival comparison by disease evaluation every 3 months after treatment
• Immunologic response to treatment by various laboratory studies before and after each course of treatment
• Quality of life by Functional Assessment of Chronic Illness Therapy Fatigue Subscale RSF-36 SDS before and after the first course of treatment

RATIONALE: Aldesleukin may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating metastatic melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of aldesleukin with or without vaccine therapy in treating patients with stage III or stage IV melanoma.

OBJECTIVES:

• Compare the efficacy of high-dose aldesleukin (IL-2) with or without gp100 antigen with regard to clinical response in patients with locally advanced or metastatic cutaneous melanoma.
• Compare the toxic effects of these 2 regimens in these patients.
• Compare the disease-free and progression-free survival of patients treated with these 2 regimens.
• Determine the immunologic response experienced by patients who have received the peptide vaccination, as measured by changes in T-cell precursors from before to after treatment.
• Evaluate the quality of life of these patients before and after the first course of high-dose IL-2.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease site (cutaneous or subcutaneous only vs any other site with or without subcutaneous disease).

Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive aldesleukin (IL-2) IV over 15 minutes every 8 hours for 12 doses.
• Arm II: Patients receive gp100 antigen emulsified in Montanide ISA-51 subcutaneously on day 1. Patients also receive IL-2 as in arm I beginning on day 2.

In both arms, treatment repeats every 3 weeks for 2 courses. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Quality of life is assessed before and after the first course of IL-2.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 93-185 patients (46-93 per treatment arm) will be accrued for this study within 2 years.

• Biological: aldesleukin
• Biological: gp100 antigen
• Biological: incomplete Freund's adjuvant

• Active Comparator: Patients receive aldesleukin (IL-2) IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
• Experimental: Patients receive gp100 antigen emulsified in Montanide ISA-51 subcutaneously on day 1. Patients also receive IL-2 as in arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

DISEASE CHARACTERISTICS:

• Histologically proven locally advanced stage III or stage IV cutaneous melanoma

  • No ocular or mucosal melanoma
• Measurable disease
• HLA-A0201 positive
• No brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Greater than 3 months

Hematopoietic:

• WBC at least 3,000/mm^3
• Platelet count at least 90,000/mm^3
• No coagulation disorder

Hepatic:

• Bilirubin no greater than 1.6 mg/dL
• AST or ALT less than 3 times normal
• No hepatitis B or C

Renal:

• Creatinine no greater than 1.6 mg/dL

Cardiovascular:

• No prior cardiac ischemia, myocardial infarction, or cardiac arrhythmias
• Normal stress cardiac test (e.g., stress thallium or stress MUGA)

Pulmonary:

• No prior obstructive or restrictive pulmonary disease
• FEV_1 at least 65% OR
• FVC at least 65%

Other:

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No active systemic infections
• No autoimmune disease
• No history of other major medical illnesses (e.g., insulin-dependent diabetes mellitus or inflammatory bowel disorder)
• No significant psychiatric disease
• No primary or secondary immunodeficiency

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior biologic therapy
• No prior high-dose aldesleukin (600,000 IU/kg or more)
• No prior gp100 vaccines
• No other concurrent biologic therapy

Chemotherapy:

• At least 4 weeks since prior chemotherapy
• No concurrent chemotherapy

Endocrine therapy:

• At least 4 weeks since prior systemic steroids
• At least 2 weeks since prior topical or inhalational steroids
• No concurrent steroid therapy or steroid-like compounds

Radiotherapy:

• At least 4 weeks since prior radiotherapy to any site
• No concurrent radiotherapy to any site

Surgery:

• Prior surgery allowed