TEMOZOLOMIDE IN 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: 6244474
• 负责人: PETER PHILLIPS
• 金额: $ 2.36万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-17 至 1998-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6244474
• 关键词: antineoplastics; astrocytoma; clinical research; drug screening /evaluation; human subject; human therapy evaluation; long term survivor; neoplasm /cancer chemotherapy; neoplasm /cancer relapse /recurrence; pharmacokinetics; quality of life

It is hypothesized that Temozolomide produceds a 20% 6 month progression free-survival rate in patients with anaplastic astrocytoma at first relapse. The specific aims are: 1) To determine the efficacy of temozolomide defined as progression-free survival at six months and the safety of this agent 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 (HQL) of patients enrolled in the study; 3) To assess population- based pharmacokinetics in patients receiving temozolomide; 4) To assess overall survival for all patients receiving temozolomide.

推测替莫唑胺的6个月进展率为20% 间变性星形细胞瘤患者最初的自由存活率 旧病复发。其具体目的是：1)确定其疗效 替莫唑胺定义为6个月的无进展生存期， 口服这种药物的安全性，每天一次，连续五天， 间变性患者每28天重复一次的治疗 星形细胞瘤首次复发；2)描述与健康相关的质量 参与研究的患者的生命(HQL)；3)评估人群- 基于替莫唑胺患者的药代动力学；4)评估 接受替莫唑胺治疗的所有患者的总存活率。