PHASE III, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF CT1501R

CT1501R 的 III 期、随机、双盲、安慰剂对照研究

• 批准号: 3740344
• 负责人: MICHAEL B ATKINS
• 金额: --
• 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/3740344
• 关键词: antineoplastics; clinical trials; dosage; drug tolerance; human subject; human therapy evaluation; interleukin 2; neoplasm /cancer chemotherapy; theobromine

This protocol is attempting to reduce the toxicity associated with IL-2 therapy without interfering with its anti-tumor activity. It combines the standard Interlukin-2 regimen, as approved by the FDA, with the experimental agent, CT1501R , a metabolite of pentoxifylline, the blood levels of which has been shown to correlate with improved tolerance to IL-2 therapy. The dose of CT-1501R to be used in this study was determined in a phase I study combining it with IL-2 to produce steady state blood levels.

该方案试图减少与IL-2相关的毒性， 治疗而不干扰其抗肿瘤活性。 它结合 FDA批准的标准白细胞介素-2方案， 实验药物，CT 1501 R，一种戊茶碱的代谢产物，血液 其水平已被证明与改善的耐受性相关， IL-2治疗。 本研究中使用的CT-1501 R剂量为 在I期研究中确定，将其与IL-2结合以产生稳定的 血液水平。