Protocol Number: 08-C-0056
-MART-1 is a gene present in melanoma cells. -An experimental procedure developed for treating patients with melanoma uses the anti-MART-1 F5 gene and a type of virus to make special cells called anti-MART-1 F5 cells that are designed to destroy the patient's tumor. These cells are created in the laboratory using the patient's own tumor cells or blood cells. -The treatment procedure also uses a vaccine called ALVAC MART-1, made from a virus that ordinarily infects canaries and is modified to carry a copy of the MART-1 gene. The virus cannot reproduce in mammals, so it cannot cause disease in humans. When the vaccine is injected into a patient, it stimulates cells in the immune system that may increase the efficiency of the anti-MART-1 F5 cells. Objectives: -To evaluate the safety and effectiveness of anti-MART-1 F5 and the ALVAC vaccine in treating patients with advanced melanoma. Eligibility: -Patients 18 years of age with metastatic melanoma for whom standard treatments have not been effective. Design: -Patients undergo scans, x-rays and other tests and leukapheresis to obtain white cells for laboratory treatment. -Patients have 7 days of chemotherapy to prepare the immune system for receiving the anti-MART-1 F5. -Patients receive the ALVAC vaccine, anti-MART-1 F5 cells and IL-2 (an approved treatment for advanced melanoma). The anti-MART-1 F5 cells are given as an infusion through a vein. The vaccine is given as injections just before the infusion of anti-MART-1 F5 cells and again 2 weeks later. IL-2 is given as a 15-minute infusion every 8 hours for up to 5 days after the cell infusion for a maximum of 15 doses. -After hospital discharge, patients return to the clinic for periodic follow-up with a physical examination, review of treatment side effects, laboratory tests and scans every 1 to 6 months.
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