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

Inclusion Criteria

• •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