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Protocol Number: 04-C-0152 
Patients 16 years of age and older with melanoma that has spread beyond the original site and that does not respond to standard treatment may be eligible for this study. Candidates are screened with a medical history and physical examination, chest x-ray, electrocardiogram, blood and urine tests, and x-rays and scans to the evaluate the extent and size of the tumor. Because the experimental preparation is based on tissue type, only patients with tissue type HLA-A*0201 may participate. Tissue type is determined by a blood test. Participants undergo the following procedures: -Leukapheresis, a procedure for collecting lymphocytes (white blood cells): Using this procedure, special cells with good tumor-fighting ability are selected and removed for later re-infusion into the patient. To collect the cells, blood is withdrawn through a needle in an arm vein and directed through a catheter into a cell-separating machine. The lymphocytes are removed and the rest of the blood is returned to the body through the same needle. Alternatively, lymphocytes may also be collected from biopsied tumor tissue, obtained either with a needle or by a small cut in the tumor. -G-CSF injections: This growth factor is injected under the skin every day for 5 days to stimulate white blood cell production. -Catheter placement: Upon admission to the Clinical Center for treatment, the patient has a catheter (plastic tube) placed in a vein in the neck or arm for giving chemotherapy and other medicines, for infusing the lymphocytes, and for collecting blood samples. -Leukapheresis: Repeated in the hospital to collect and store blood that may be needed in the rare event that the patient's blood components do not recover after chemotherapy. -Chemotherapy: A week before the lymphocyte infusion, patients receive a 1-hour infusion of cyclophosphamide for 2 days and then a 15- to 30-minute infusion of fludarabine for 5 days to suppress the immune system and thereby prevent rejection of the infused lymphocytes. -Vaccine and lymphocyte delivery: The vaccine is injected through the catheter, followed by a 30-minute infusion of the lymphocytes. -IL-2 and G-CSF: Patients receive IL-2 infusions every 8 hours for up to 5 days after the cell infusion to help keep the cells alive, and G-CSF injections under the skin every day after the cell infusion until white cells increase to a sufficient number. The entire hospital stay is usually 12 to 16 days. About 4 weeks after the lymphocyte infusion, patients are re-admitted to the hospital for about 10 days for a second vaccine injection and course of IL-2 infusions. Between 2 and 4 weeks after completing the full treatment regimen, patients return to NIH for evaluation. Those whose tumors have shrunk or remained stable may repeat the entire treatment regimen two times. Those whose tumors continued to grow may be re-treated with infusion of lymphocytes through an artery instead of a vein if their tumors receive blood from a major artery. If this is not feasible, or if it is tried without success, the patients will be taken off the study.
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National Institutes of Health Clinical Center