Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
Intraocular Melanoma, Melanoma (Skin)

About this trial
This is an interventional treatment trial for Intraocular Melanoma focused on measuring stage III melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent melanoma, recurrent intraocular melanoma, metastatic intraocular melanoma
Eligibility 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
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Arms of the Study
Arm 1
Experimental
Arm 1