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

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