Monoclonal Antibody Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed stage IV melanoma
• * Mucosal or ocular melanoma also eligible
• Clinically evaluable disease
• * At least 1 site of measurable disease
• PATIENT CHARACTERISTICS:
• Age
• 16 and over
• Performance status
• ECOG 0-1
• Life expectancy
• At least 3 months
• Hematopoietic
• WBC at least 2,500/mm\^3
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 10 g/dL
• Hematocrit at least 30%
• Hepatic
• Bilirubin no greater than upper limit of normal (ULN)\* (less than 3.0 mg/dL in patients with Gilbert's syndrome)
• AST no greater than 3 times ULN\*
• Hepatitis B surface antigen negative
• Hepatitis C antibody nonreactive
• No evidence or history of significant hepatic disease that would preclude safe administration of high-dose IL-2 NOTE: \*Unless attributable to disease
• Renal
• Creatinine no greater than 2.0 mg/dL
• No evidence or history of significant renal disease that would preclude safe administration of high-dose IL-2
• Cardiovascular
• No evidence or history of significant cardiac disease that would preclude safe administration of high-dose IL-2
• Thallium stress test normal (for patients over 50 years of age or with a history of cardiovascular disease)
• Pulmonary
• No evidence or history of significant pulmonary disease that would preclude safe administration of high-dose IL-2
• Immunologic
• HIV negative
• No autoimmune disease (including uveitis and autoimmune inflammatory eye disease)
• No active infection
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
• No evidence or history of significant gastrointestinal disease that would preclude safe administration of high-dose IL-2
• No evidence or history of psychiatric disease that would preclude safe administration of high-dose IL-2
• No other underlying medical condition that would make the administration of the study drug hazardous or obscure the interpretation of adverse events
• No other concurrent medical condition that would preclude study entry
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• At least 3 weeks since prior immunotherapy for melanoma and recovered
• No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4)
• No prior high-dose (at least 600,000 IU/kg every 8 hours) interleukin-2 (IL-2)
• Chemotherapy
• At least 3 weeks since prior chemotherapy for melanoma and recovered
• No concurrent chemotherapy
• Endocrine therapy
• At least 3 weeks since prior hormonal therapy for melanoma and recovered
• At least 4 weeks since prior corticosteroids
• No concurrent systemic or topical corticosteroids
• Radiotherapy
• At least 3 weeks since prior radiotherapy for melanoma and recovered
• Surgery
• Not specified
• Other
• No concurrent immunosuppressive agents (e.g., cyclosporine or its analog)