Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage III melanoma, stage IV melanoma
Eligibility Criteria
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
Sites / Locations
- Massachusetts General HospitalRecruiting
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
Patients undergo surgical harvesting of tumor cells for subsequent fusion. Patients receive vaccination comprising dendritic cells (DC) fused with autologous tumor cells subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who achieve a partial (PR) or complete response (CR) may receive an additional 3 courses.
Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may receive an additional 6 courses.