IL 12 GENE THERAPY HEAD/NECK CANCER TUMORS W/ AUTOLOGOUS FIBROBLASTS

IL 12 基因治疗头颈癌肿瘤与自体成纤维细胞

• 批准号: 6304616
• 负责人: HIDEAKI TAHARA
• 金额: $ 0.3万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6304616
• 关键词: clinical research; fibroblasts; gene therapy; head /neck neoplasm; human subject; human therapy evaluation; immunoregulation; interferon gamma; interleukin 10; interleukin 12; neoplasm /cancer immunotherapy

This is a Phase II IL-12 gene therapy for head and neck cancer using direct injection of tumors with genetically engineered autologous fibroblasts study. The aims of this study are 1) to determine whether ex-vivo IL-12 gene therapy delivered via peritumorally injected autologous fibroblasts has clinical antitumor activity in head and neck cancer; 2) to characterize the local immunomodulatory effects of this procedure; 3) to characterize the systemic immunomodulatory effects of this procedure; specifically serum IL-10, IL-12 and IFN-y levels; 4) to characterize the correlations among immuno-modulation measures and between those measures and clinical indicators or response and 5) to identify possible pretreatment predictors of clinical, pathologic or immunologic response.

这是一项II期IL-12基因治疗头颈癌的研究，使用基因工程的自体成纤维细胞直接注射肿瘤。本研究的目的是：1)确定通过瘤周注射自体成纤维细胞给药的IL-12基因治疗在头颈癌中是否具有临床抗肿瘤活性；2)描述该手术的局部免疫调节作用；3)描述该程序的全身免疫调节作用；特别是血清IL-10、IL-12和IFN-y水平；4)表征免疫调节措施之间以及这些措施与临床指标或反应之间的相关性；5)确定临床、病理或免疫反应可能的预处理预测因子。