A Randomized Phase II Study of Immunization Against Melanoma Comparing Autologous Dendritic Cells Pulsed With gp100 Peptide to Autologous Dendritic Cells Fused With Autologous Tumor Cells

Date de début de l'étude : 1 mars 2004

DISEASE CHARACTERISTICS: * Histologically confirmed cutaneous melanoma * Stage III or IV disease * Recurrent or de novo stage III disease allowed if disease is unresectable and no definitive treatment is available * gp100- and HLA-A201-positive * Surgically accessible tumor, defined by 1 of the following: * Pulmonary lesions approachable by thoracoscopic procedure * Skin or superficial soft tissue or lymph node lesions amenable to resection under local anesthesia * Malignant ascites or pleural effusion * Measurable disease in addition to surgically accessible tumor \> 2.0 cm * No CNS metastases * No mucosal or ocular melanoma PATIENT CHARACTERISTICS: Age * Any age Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * WBC \> 3,000/mm\^3 * Platelet count \> 75,000/mm\^3 Hepatic * Bilirubin \< 2.0 mg/dL Renal * Creatinine \< 2.0 mg/dL Immunologic * No active infection requiring treatment * No clinically significant autoimmune disorder * No immune deficiency disorder * HIV negative Other * Antecubital vein accessible for leukapheresis * No other malignancy within the past 5 years except nonmelanoma skin cancer or squamous cell carcinoma in situ of the cervix * No pre-existing comorbid disease that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No prior melanoma vaccine therapy * More than 6 weeks since prior immunotherapy Chemotherapy * No prior chemotherapy for metastatic melanoma Endocrine therapy * No concurrent corticosteroids Radiotherapy * More than 6 weeks since prior radiotherapy Surgery * Not specified Other * No concurrent systemic immunosuppressive therapy