Protocol Number: 07-C-0175
-Human peripheral blood lymphocytes have been engineered to express a T-cell receptor (TCR) that recognizes a blood type, HLA-A 0201 derived from the gp100 protein. A retroviral vector was constructed that can deliver the TCR to cells. -Patients' cells will be converted into cells able to recognize and fight melanoma tumors. Objectives: -To determine whether TCR-engineered lymphocytes can be put in cells removed from patients' tumors or blood and then reinfused, with the purpose of shrinking tumors. -To evaluate safety and effectiveness of the treatment. Eligibility: -Patients 18 years of age or older with metastatic cancer melanoma (cancer that has spread beyond the original site). -Patient's leukocyte antigen type is HLA-A 0201. Design: -Patients undergo the following procedures: --Leukapheresis (on two occasions). This is a method of collecting large numbers of white blood cells. The cells obtained in the first leukapheresis procedure are grown in the laboratory, and the anti-MART-1 protein is inserted into the cells using an inactivated (harmless) virus in a process called retroviral transduction. Cells collected in the second leukapheresis procedure are used to evaluate the effectiveness of the study treatment. --Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) over 1 hour for 2 days to suppress the immune system so that the patient's immune cells do not interfere with the treatment. --Treatment with anti-MART-1. Patients receive an IV infusion of the treated cells containing anti-MART-1 protein, followed by infusions of a drug called IL-2, which helps boost the effectiveness of the treated white cells. --Patients are given support medications to prevent complications such as infections. --Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue). --Patients are evaluated with laboratory tests and imaging tests, such as CT scans, 4 to 6 weeks after treatment and then once a month for 3 to 4 months to determine the response to treatment. --Patients have blood tests at 3, 6, and 12 months and then annually for 5 years.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/17/2009
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