Ipilimumab With or Without Vaccine Therapy in Treating Patients With Previously Treated Stage IV Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma
Eligibility 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