Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

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)