TEMOZOLOMIDE IN THE TREATMENT OF ANAPLASTIC ASTROCYTOMA AT FIRST RELAPSE

替莫唑胺治疗初次复发的间变性星形细胞瘤

• 批准号: 6246438
• 负责人: JAMES K. WILLSON
• 金额: $ 1.98万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-01-06 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6246438
• 关键词: antineoplastics; clinical research; drug screening /evaluation; glioblastoma multiforme; human morbidity; human mortality; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer relapse /recurrence; oral administration; pharmacokinetics; quality of life

The objectives of this trial are: 1) To determine the efficacy of temozolomide defined as progression-free survival at 6 months and safety of temozolomide when administered orally, once a day for five days repeated every 28 days in the treatment of patients with anaplastic astrocytoma at first relapse. 2) To describe the health-related quality of life of all patients. 3) To assess population-based pharmacokinetics in patients receiving temozolomide. 4) To assess overall survival for all patients. There was one patient enrolled in the past year and the trial has been closed due to lack of accrual.

本试验的目的是：1）确定 替莫唑胺定义为6个月时的无进展生存期和安全性 口服替莫唑胺，每日一次，持续5天 每28天重复一次，用于治疗间变性患者 星形细胞瘤首次复发。 2)描述与健康相关的质量 所有患者的生命。 3)评估基于人群的药代动力学 在接受替莫唑胺的患者中。 4)评估所有患者的总生存期 患者 去年入组了1例患者，试验已 由于缺乏应计费用而关闭。