Ipilimumab With or Without Vaccine Therapy in Treating Patients With Previously Treated Stage IV Melanoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed stage IV melanoma
• * HLA-A\*0201 positive disease
• Previously treated metastatic disease
• Clinically evaluable and measurable disease
• No mucosal or ocular melanoma
• No evidence of active brain metastases
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-2
• WBC ≥ 2,500/mm³
• Absolute neutrophil count ≥ 1,000/mm³
• Absolute lymphocyte count ≥ 500/mm³
• Platelet count ≥ 75,000/mm³
• Hemoglobin ≥ 9 g/dL
• Creatinine \< 2.5 mg/dL
• AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• Bilirubin normal (\< 3.0 mg/dL if Gilbert's syndrome is present)
• Hepatitis B surface antigen negative
• HIV negativity
• No hepatitis C virus antibodies
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other prior malignancy except for any of the following:
• * Adequately treated basal cell or squamous cell skin cancer
• * Superficial bladder cancer
• * Carcinoma in situ of the cervix
• * Any other cancer from which patient has been disease free for \> 5 years
• No active immune-mediated disease requiring active therapy with any form of steroid or immunosuppressive therapy
• No documented history of any of the following:
• * Inflammatory bowel disease
• * Regional enteritis
• * Connective tissue disorders, such as systemic lupus erythematosus
• * Rheumatoid arthritis
• * Immune-mediated inflammatory eye disease
• * Sjögren's syndrome
• * Inflammatory neurologic disorder, such as multiple sclerosis
• * Any immune-mediated disease that can cause life-threatening symptoms or severe organ/tissue damage, in the opinion of the principal investigator
• * History of vitiligo or immune-mediated thyroiditis allowed
• * Skin rashes associated with previous therapy allowed provided patient has recovered from treatment-related toxicity to \< grade 1
• No active infection
• No systemic hypersensitivity to any of the study drugs
• * History of local reactions (e.g., delayed hypersensitivity or glaucomatous reactions) to Montanide ISA-51 allowed
• No underlying medical condition that, in the opinion of the investigator, would preclude study treatment
• PRIOR CONCURRENT THERAPY:
• At least 3 weeks since prior systemic treatment (6 weeks for nitrosoureas) and recovered
• No prior ipilimumab or gp100 vaccines
• More than 4 weeks since prior steroids
• No concurrent systemic or topical corticosteroids or immunosuppressive agents (e.g., cyclosporine or chemotherapy agents), including steroid enemas, inhaled steroids, or steroid eye drops
• * Hormone-replacement therapy allowed