PHASE I STUDY OF TEMOZOLOMIDE IN TREATMENT OF ANAPLASTIC ASTROCYTOMA

替莫唑胺治疗间变性星形细胞瘤的 I 期研究

• 批准号: 6246373
• 负责人: MICHAEL D PRADOS
• 金额: $ 4.89万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-04 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6246373
• 关键词: antineoplastics; blood chemistry; clinical research; clinical trial phase I; drug administration rate /duration; drug screening /evaluation; glioblastoma multiforme; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer relapse /recurrence; oral administration; pharmacokinetics

Temozolomide will be evaluated for safety, efficacy, maximum tolerated dose and pharmacokinetics in patients with Anaplastic Astrocytoma experiencing first relapse. Temozolomide will be administered orally 1/day x 5 days every 28 days. Pts will fast 4 hrs before and 2 hrs after each dose. Pharmacokinetics will be drawn on Day 1 Cycle 1. All patients will be drawn at baseline (before dosing) and 4 times post- dosing.

替莫唑胺的安全性、有效性和最大耐受性将被评估