Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma

OBJECTIVES:

• Compare immune response in patients with stage IIB-IV melanoma treated with vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 with vs without sargramostim (GM-CSF).
• Compare immune response in patients treated with these vaccinations administered at 1 vs 2 sites.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 1 injection site.
• Arm II: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 2 injection sites.
• Arm III: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) at 1 injection site.
• Arm IV: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF at 2 injection sites.

In all arms, treatment repeats once weekly for 6 weeks. Patients return for booster vaccinations at weeks 12, 26, 39, and 52.

PROJECTED ACCRUAL: A maximum of 124 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of melanoma

• Stage IIB, IIC, III, or IV disease
• Must express HLA-A1, -A2, or -A3
• No ocular melanoma

PATIENT CHARACTERISTICS:

Age

• 12 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3
• Platelet count > 100,000/mm^3
• Hemoglobin > 9 g/dL

Hepatic

• Liver function tests ≤ 2.5 times upper limit of normal (ULN)

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No New York Heart Association class III or IV heart disease

Other

• Not pregnant or nursing
• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer without brain metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 weeks since prior immunotherapy
• More than 4 weeks since prior growth factors
• More than 4 weeks since prior allergy shots
• No prior vaccine therapy for melanoma or any other cancer with any of the peptides used in this study
• More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine

Chemotherapy

• More than 4 weeks since prior chemotherapy

Endocrine therapy

• More than 4 weeks since prior steroids

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified