PHASE I TRIAL INTRAPERITONEAL ADENOVIRAL P53 GENE THERAPY--OVARIAN CANCER

I期试验腹腔内腺病毒P53基因治疗——卵巢癌

• 批准号: 6265031
• 负责人: CAROLYN Y MULLER
• 金额: $ 3.48万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265031
• 关键词: PHASE; TRIAL; INTRAPERITONEAL; ADENOVIRAL; P53

The specific aims of this study are to 1) determine the maximal tolerated dose and toxicities of adenoviral based p53 gene therapy administered intraperitoneally in patients with ascites from advanced, recurrent or persistent ovarian carcinoma; 2) evaluate the vector pharmacokinetics and biologic efficacy regarding degree of gene transfer, expression and mechanism of cell kill; and 3) determine the human immunologic response to the viral vector and systemic biodistribution following intraperitoneal administration.

本研究的具体目的是 1) 确定晚期、复发性或持续性卵巢癌腹水患者腹腔注射基于腺病毒的 p53 基因治疗的最大耐受剂量和毒性； 2) 评估载体药代动力学和关于基因转移程度、表达和细胞杀伤机制的生物学功效； 3)确定腹膜内给药后对病毒载体的人体免疫反应和全身生物分布。