Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
Intraocular Melanoma, Melanoma (Skin)
About this trial
This is an interventional treatment trial for Intraocular Melanoma focused on measuring iris melanoma, ciliary body and choroid melanoma, small size, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma, stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IV melanoma Mucosal or ocular melanoma allowed Clinically evaluable disease HLA-A*0201 positive PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life expectancy: At least 6 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: AST no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than ULN (less than 3.0 mg/dL in patients with Gilbert's syndrome) Hepatitis B surface antigen negative Hepatitis C antibody nonreactive Renal: Creatinine less than 2.0 mg/dL Immunologic: Antinuclear antibody negative Thyroglobulin antibody normal Rheumatoid factor normal HIV negative No prior autoimmune disease (including uveitis and autoimmune inflammatory eye disease) No active infection No hypersensitivity to Montanide ISA-51 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 other underlying medical condition that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy for melanoma and recovered No prior gp100 peptides No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody 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 systemic or topical corticosteroids No concurrent topical or systemic corticosteroids Radiotherapy: At least 3 weeks since prior radiotherapy for melanoma and recovered Surgery: Not specified Other: No other concurrent immunosuppressive agents (e.g., cyclosporine and its analog)
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support