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

Inclusion Criteria

• •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)