MULTIPART PHASE I CLINICAL TRIAL OF HIGH DOSE IL 2 IN COMBINATION WITH IL 1

高剂量 IL 2 与 IL 1 联合的多部分 I 期临床试验

• 批准号: 2530572
• 金额: $ 2.56万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/2530572
• 关键词: clinical research; clinical trial phase I; clinical trials; combination cancer therapy; dosage; drug screening /evaluation; human subject; human therapy evaluation; interleukin 2; intravenous administration; neoplasm /cancer immunotherapy; neoplasm /cancer pharmacology; pharmacokinetics; recombinant proteins

The objectives of this study are: To asses the safety and determine the maximum tolerated dose of intravenous rhu (CHO) IL-1R in cancer patients. To measure the pharmacokinetic profile of intravenous rhu (CHO) IL-1R in cancer patients. To determine either the effective biologic dose (EBD) as defined by inhibition of IL-2-induced CRP release or the maximum tolerated dose (MTD) of rhu (CHO) IL-1R (administered up to a maximum of 55 mg/m2 in patients undergoing high dose IL-2 therapy).

这项研究的目的是：评估安全性并确定 肿瘤患者静脉注射rhu(CHO)IL-1R的最大耐受量 静脉注射rhu(CHO)IL-1R的药动学研究 癌症患者。确定有效生物剂量(EBD) 定义为抑制IL-2诱导的CRP释放或最大 Rhu(CHO)IL-1R的耐受量(MTD)(最大给药量为 接受大剂量IL-2治疗的患者为55 mg/m2)。