CLINICAL TRIAL: A PHASE 2, OPEN-LABEL EVALUATION OF THE SAFETY AND EFFICACY OF C

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A multi-center, open-label clinical trial to evaluate the use of TLI in subjects with Stage III melanoma. Immunotherapy method is intravenous administration of autologous lymphocytes transfected with plasmid DNA. Qualifying subjects will undergo leukapheresis to obtain lymphocytes for 3 infusions ( a priming and 2 booster infusions) and specialized laboratory testing. Each booster is preceded by intravenous infusion of cyclophosphamide given 3 to 5 days prior to the TLI booster infusion. Subjects will be followed for 2 years post primary surgery.