Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With Surgery

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed cutaneous melanoma
• * Unresectable stage III OR stage IV M1a disease
• Documented progressive disease within the past 12 weeks
• Measurable disease
• Skin, soft tissue, or lymph node metastasis allowed provided the disease is not amenable to curative treatment with surgery
• Tumor must express the MAGE-3 gene by reverse transcription polymerase chain reaction analysis (more than 1% of the positive MAGE-3 control included in the assay)
• No visceral metastases within the past 56 days by imaging
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• ECOG 0-1
• Life expectancy
• Not specified
• Hematopoietic
• Hemoglobin ≥ lower limit of normal (LLN)
• WBC ≥ LLN
• Lymphocyte count ≥ LLN
• Platelet count ≥ LLN
• No bleeding disorders
• Hepatic
• Bilirubin ≤ upper limit of normal (ULN)
• Lactic dehydrogenase ≤ ULN
• AST and ALT ≤ 2 times ULN
• PT and aPTT normal
• Hepatitis B surface antigen negative (antibody test may be positive)
• Hepatitis C antibody negative
• Renal
• Creatinine ≤ ULN
• Cardiovascular
• No clinically significant heart disease (CTC grade III or IV)
• Immunologic
• No autoimmune disease (vitiligo allowed)
• No anti-nuclear antibody titer ≥ 1/320 OR equal to 1/160 AND auto-antibodies directed against specific auto-antigens
• No immunodeficiency
• No active infection requiring antibiotic therapy
• HIV negative
• Other
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other serious acute or chronic illness requiring concurrent medications
• No psychological, familial, sociological, or geographical condition that would preclude study compliance
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• More than 8 weeks since prior adjuvant vaccine therapy
• No prior vaccine therapy containing a MAGE-3 antigen
• No prior vaccine therapy for metastatic melanoma
• No concurrent immunomodulating agents (e.g., BCG)
• Chemotherapy
• No prior systemic chemotherapy
• No concurrent chemotherapy
• Endocrine therapy
• No concurrent corticosteroids
• * Concurrent prednisone or equivalent allowed provided the dose is ≤ 40 mg/day and treatment duration is for no more than 3 weeks
• * Concurrent inhaled and topical steroids are allowed
• Radiotherapy
• No prior radiotherapy to the spleen
• No concurrent radiotherapy to \> 20% of all existing lesions (i.e., target lesions, non-target lesions, and nonmeasurable lesions)
• * Concurrent local low-dose (≤ 20 Grays) radiotherapy allowed
• Surgery
• Recovered from prior surgery or biopsy
• No prior organ allograft
• No prior splenectomy
• Concurrent surgery to a limited number of lesions allowed for patients with a complete response, partial response, or stable disease after at least 3 courses of study therapy
• Other
• No prior systemic anticancer therapy
• More than 4 weeks since prior isolated limb perfusion therapy
• No other concurrent anticancer therapy
• No other concurrent immunosuppressive agents