Autologous anti-MART-1 F5 T-cell receptor gene-engineered tumor infiltrating lymphocytes(NCI)

Background:
Human peripheral blood lymphocytes have been engineered to express a T-cell receptor (TCR) that recognizes a blood type,HLA-A 0201 (human leukocyte antigen) derived from the gp100 protein. A retroviral vector was constructed that can deliver the T-cell receptor (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-melanoma antigen recognized by T-cells (MART)-1. Patients receive an intravenous (IV) infusion of the treated cells containing anti-MART-1 protein, followed by infusions of a drug called IL-2 (aldesleukin), 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 (computed tomography) 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.