PHASE I STUDY OF SEQUENTIAL CPT 11 & MITOMYCIN C

序贯 CPT 11 的第一阶段研究

• 批准号: 6586834
• 负责人: MIGUEL A VILLALONA-CALERO
• 金额: $ 23.48万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-12-01 至 2002-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6586834
• 关键词: antineoplastic antibiotics; child (0-11); clinical research; clinical trial phase I; combination cancer therapy; combination chemotherapy; dihydrolipoamide dehydrogenase; dosage; drug interactions; drug screening /evaluation; enzyme activity; human subject; human therapy evaluation; mitomycin C; pharmacokinetics

The objectives of this protocol are to determine the maximum tolerated dose of Mitomycin C (MMC) when given in combination with CPT-11, to determine if the pharmacokinetic behavior of CPT-11 is altered prior to administration of MMC, to determine the effect of CPT-11 and MMC on the expression of DT-Diaphorase and the Topo I gene, and to evaluate the antitumor activity of the combination.

该方案的目标是确定与CPT-11结合给出丝裂霉素C（MMC）的最大耐受剂量，以确定在给药之前CPT-11的药代动力学行为是否改变了MMC，以确定CPT-11和MMC关于DT-肌酶和Topo I基因的表达，并评估组合的抗肿瘤活性。