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Protocol Number: 04-C-0288 
Patients 18 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 scans to the evaluate the extent and size of the tumor. Participants undergo the following procedures: - Tumor biopsy and cell culture: A small area of skin is numbed and a piece of tumor is removed with a needle or a small incision. Tumor cells that show the ability to respond to melanoma cells are grown in the laboratory for about 40 days for later infusion into the patient. - G-CSF injections: This growth factor is injected under the skin twice a day for 5 days to stimulate white blood cell production for apheresis, a procedure for collecting quantities of stem cells (see below). - Apheresis: To collect stem cells, blood is withdrawn through a needle in an arm vein and directed through a catheter into a cell-separating machine. The stem cells are removed and the rest of the blood is returned to the patient through a second needle in the other arm. - Chemotherapy: Patients receive two immune-suppressing drugs, cyclophosphamide and fludarabine, through a catheter (flexible plastic tube) placed in a vein in the arm, upper chest, or neck. The cyclophosphamide is given over 1 hour for 2 days and the fludarabine is given for 15 to 30 minutes for 5 days. These drugs are not intended to treat the tumor, but to try to improve the immune therapy. - Radiation therapy: The day after completing chemotherapy, patients receive high-dose radiation therapy. - Tumor-fighting cell infusion: The day after radiation therapy, patients are given the tumor-fighting cells by infusion through the catheter over 30 minutes. - IL-2: Patients receive high-dose IL-2 infusions every 8 hours for up to 5 days after the cell infusion to help keep the cells alive. Patients who cannot receive high-dose IL-2 receive the drug in low doses as an injection under the skin once a day for 5 days, followed by a 2-day break and continue this 7-day cycle for 6 weeks. - Stem cell infusion: Two days after receiving the tumor-fighting cells, patients are given the stem cells that were collected by apheresis to regenerate the immune system and bone marrow. - G-CSF injections: Patients receive G-CSF injections under the skin every day to stimulate blood cell production until the cells increase to a sufficient number. - Optional biopsy: Patients may be asked to undergo a tumor or lymph node biopsy after the treatment is completed to examine the effects of treatment on the immune cells in the tumor. Four to 6 weeks after receiving the cell infusion, patients return to NIH for a 2-day inpatient evaluation. Patients whose tumors do not respond or continues to grow are removed from the study and offered other experimental treatment options or returned to the care of their home physician.
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National Institutes of Health Clinical Center