Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With Surgery
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma, recurrent melanoma
Eligibility 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
Sites / Locations
- Institut Jules Bordet
- Hopital Universitaire Erasme
- Clinique Sainte-Marguerite
- Centre Hospitalier Regional et Universitaire de Lille
- Hopital St. Eloi
- CHR Hotel Dieu
- Institut Curie Hopital
- Institut Gustave Roussy
- Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
- Klinikum der Stadt Mannheim
- Universitaets - Kinderklinik Wuerzburg
- Centro di Riferimento Oncologico - Aviano
- Istituto Nazionale per lo Studio e la Cura dei Tumori
- Azienda Ospedaliera di Padova
- Universita di Siena
- Leiden University Medical Center
- Daniel Den Hoed Cancer Center at Erasmus Medical Center
- Hospital Clinic de Barcelona
- Hospital Universitario 12 de Octubre
- Saint Bartholomew's Hospital
- Christie Hospital NHS Trust