An Extended Dosing, Two-phase Study of MDX-010 as Monotherapy or in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 VG in the Treatment of Subjects With Resected Stage III or Stage IV Melanoma

Date de début de l'étude : 31 mai 2004

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