A Randomized Phase II Trial of a Vaccine Combining Tyrosinase/gp100 Peptides Emulsified With Montanide ISA 51 With and Without Interleukin-12 for Patients With Resected Stages III and IV Melanoma

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven stage III or IV cutaneous or ocular
melanoma that can be completely resected or rendered free of disease but is at high risk
of recurrence OR Recurrent disease following interferon alfa or ineligible for or refused
interferon alfa HLA-A2 positive Tumor tissue must be available for analysis of
gp100/tyrosinase expression Detectable expression of one or the other antigen not required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Absolute granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic:
Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine
clearance at least 60 mL/min Cardiovascular: No major cardiovascular illness Pulmonary: No
major respiratory illness (e.g., pneumonia) Gastrointestinal: No major gastrointestinal
illness Other: Not pregnant or nursing No major systemic infection (e.g., sepsis) No
coagulation or bleeding disorder HIV negative Hepatitis B surface antigen negative
Hepatitis C surface antigen negative No history of uveitis or autoimmune inflammatory eye
disease No active autoimmune disease Not allergic to Montanide ISA-51 No active second
malignancy within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 month
since prior biologic therapy Chemotherapy: At least 1 month since prior chemotherapy,
including adjuvant therapy Endocrine therapy: At least 1 month since prior endocrine
therapy No concurrent steroid therapy Radiotherapy: At least 1 month since prior
radiotherapy Surgery: See Disease Characteristics At least 1 month since prior surgery