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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 一项评估TLI在III期黑色素瘤受试者中使用的多中心开放标签临床试验。免疫治疗的方法是静脉注射转染质粒DNA的自体淋巴细胞。符合条件的受试者将接受白细胞分离，以获得淋巴细胞，以进行3次输注(1次预充和2次强化输注)和专门的实验室测试。每次强化治疗前，在TLI强化注射前3-5天静脉注射环磷酰胺。受试者将在初次手术后接受为期2年的跟踪调查。

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.