• Whether the addition of peptide vaccine to high-dose aldesleukin is superior to alaldesleukin alone by response rates after each course of treatment [ Designated as safety issue: No ]
  

• 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 ]
  

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.

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