Anti-MART-1 F5 Lymphocytes to Treat High-Risk Melanoma Patients

Study Summary

Background: * Melanoma antigen recognized by T cells (MART-1) is a gene that is present in melanoma cells. * This study tests an experimental treatment that uses the patient's own lymphocytes (type of white blood cell), which are specially selected and genetically modified with a gene called anti-MART-1 transduced cells (F5) to target and destroy their tumor. Some of the cells are given as an infusion and others are given as a vaccine. * The anti-MART-1 F5 cells are currently being studied in other patients in combination with chemotherapy and IL-2 (aldesleukin) therapy. Objectives: -To determine if the anti-MART-1 F5 treatment can improve the immune system's ability to shrink tumors and to prevent melanoma from recurring. Eligibility: * Patients 18 years of age and older whose melanoma has been removed and are currently disease-free, but who are at risk for recurrence. * Patients who do not have ocular or mucosal melanoma. * Patients with tissue type human leukocyte antigens (HLA-A)\*0201). Design: * Workup: Patients have scans, x-rays, laboratory tests, other tests as needed and leukapheresis, a procedure for collecting white cells to modify in the laboratory and later reinfuse into the patient. * Patients are assigned to one of four study groups: * Group 1 receives anti-MART-1 F5 cells by 30-minute infusion through a vein on day 0. * Group 2 receives anti-MART-1 F5 cells on day 0 followed by injections of MART-1 vaccine, which contains MART-1 and an oil-based liquid called Montanide ISA-51 VG. The vaccine is repeated on day 30. * Group 3 receives anti-MART-1 F5 cells on day 0 followed by injections of low-dose IL-2 for 5 days (days 0-4). * Group 4 receives anti-MART-1 F5 cells on day 0 followed by MART-1 vaccine and low-dose IL-2 for 5 days. The vaccine is repeated on day 30. * Recovery: Patients are monitored closely and given medicines to prevent or treat any side effects of therapy. * Leukapheresis: Patients undergo leukapheresis at 1 and 3 mon

Primary Outcome

Percentage of participants with an immunologic response of \>20 spots/100,000 cells measured by IFN gamma secretion using enzyme linked immunosorbent spot (ELISPOT) assay. This was done using ELISPOT assay which measures immune response at the single cell level.

Interventions

• BIOLOGICAL Aldesleukin
• BIOLOGICAL incomplete Freund's adjuvant
• BIOLOGICAL ALVAC-MART-1 vaccine
• BIOLOGICAL MART-1:26-35(27L) peptide vaccine
• BIOLOGICAL autologous anti-MART-1 F5 T-cell receptor gene-engineered peripheral blood lymphocytes