vaccine therapy and monoclonal antibody therapy in treating patients with stage iv melanoma

Conditions: Intraocular Melanoma; Melanoma (Skin)

Summary: rationale: vaccines made from peptides may make the body build an immune response to kill tumor cells. monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. combining vaccine therapy with a monoclonal antibody may cause a stronger immune response and kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining vaccine therapy with monoclonal antibody therapy in treating patients who have stage iv melanoma.

objectives: * determine the clinical response in patients with stage iv melanoma when treated with anti-cytotoxic t-lymphocyte-associated antigen-4 monoclonal antibody combined with gp100:209-217 and gp100:280-288 peptides emulsified in montanide isa-51. * determine a safety and adverse event profile of this regimen in these patients. * determine improved immunologic response in patients treated with this regimen. outline: this is an open-label study. patients receive anti-cytotoxic t-lymphocyte-associated antigen-4 monoclonal antibody iv over 90 minutes immediately followed by gp100:209-217 and gp100:280-288 peptides emulsified in montanide isa-51 subcutaneously on days 1, 22, 43, and 64. treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity. patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. projected accrual: a total of 68 patients will be accrued for this study within 2 years.

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)

Keywords: 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