Randomized, Open Phase II Study of Immunization With the Recombinant MAGE-3 Protein Combined With Adjuvant AS02B or AS15 in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

Fecha de inicio: 1 de mayo de 2004

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