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

Inclusion Criteria

• •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