Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed melanoma
• •* Stage III (≥ 3 positive lymph nodes) or stage IV disease
• •* Mucosal or ocular melanoma allowed
• •Completely resected within the past 6 months
• •Patients with stage III resected melanoma rendered free of disease may have failed, been ineligible for, or refused prior treatment with interferon alfa
• •Positive staining of tumor tissue for at least one of the following:
• •* Antibody HMB-45 for gp100
• •* Antibody HMB-45 for tyrosinase
• •* Antibody HMB-45 for MART-1
• •HLA-A\*0201 positive by DNA allele-specific polymerase chain reaction assay
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-1
• •Life expectancy
• •At least 6 months
• •Hematopoietic
• •WBC ≥ 2,500/mm\^3
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hematocrit ≥ 30%
• •Hemoglobin ≥ 10 g/dL
• •Hepatic
• •AST ≤ 3 times upper limit of normal (ULN)\*
• •Bilirubin ≤ ULN\* (\< 3.0 mg/dL for patients with Gilbert's syndrome)
• •No significant hepatic disease that would preclude study participation
• •Hepatitis B surface antigen negative
• •Hepatitis C antibody negative NOTE: \* Unless attributable to disease
• •Renal
• •Creatinine ≤ 2.0 mg/dL
• •No significant renal disease that would preclude study participation
• •Cardiovascular
• •No significant cardiac disease that would preclude study participation
• •Pulmonary
• •No significant pulmonary disease that would preclude study participation
• •Immunologic
• •No history of any of the following:
• •* Inflammatory bowel disease or any other autoimmune bowel disease
• •* Systemic lupus erythematosus
• •* Rheumatoid arthritis
• •* Autoimmune ocular disease
• •No systemic hypersensitivity to Montanide ISA-51 or any vaccine component
• •No active infection requiring therapy
• •HIV negative
• •Other
• •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 significant gastrointestinal disease that would preclude study participation
• •No significant psychiatric disease that would preclude study participation
• •No other medical condition that would preclude study participation
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for at least 4 months after study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •See Disease Characteristics
• •No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010)
• •No prior gp100 antigen, MART-1 antigen, or tyrosinase peptide
• •At least 4 weeks since prior immunotherapy for melanoma and recovered
• •No other concurrent immunotherapy
• •Chemotherapy
• •At least 4 weeks since prior chemotherapy for melanoma (6 weeks for nitrosoureas) and recovered
• •No concurrent chemotherapy
• •Endocrine therapy
• •At least 4 weeks since prior hormonal therapy for melanoma and recovered
• •At least 4 weeks since prior systemic, inhaled, or topical corticosteroids
• •No concurrent systemic, inhaled, or topical corticosteroids
• •Radiotherapy
• •At least 4 weeks since prior radiotherapy for melanoma and recovered
• •Surgery
• •See Disease Characteristics
• •At least 4 weeks since prior surgery for melanoma and recovered
• •Other
• •No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)
• •Concurrent analgesic therapy allowed provided the dose is stable for the past 14 days