PHASE I/II STUDY OF PACLITAXEL CHEMOTHERAPY IN RECURRENT MALIGNANT GLIOMA

紫杉醇化疗治疗复发性恶性胶质瘤的 I/II 期研究

• 批准号: 6275822
• 负责人: MICHAEL BOZIK
• 金额: $ 1.91万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6275822
• 关键词: clinical research; clinical trial phase I; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; injection /infusion; neoplasm /cancer chemotherapy; neoplasm /cancer relapse /recurrence; paclitaxel; pharmacokinetics

The purpose of this Phase II study is to study the effectiveness, side effects & maximum tolerated dose of the drug Paclitaxel (Taxol) in treating patients with recurrent malignant glioma. All patients will be premedicated prior to Taxol infusion using the drugs Dexamethasone, Diphenhydramine & Ranitidine or Cimetidine prior to treatment. The objective of the pharmacokinetics studies will be to determine the concentration of paclitaxel achieved after a 3-hour infusion once every 3 weeks until documented tumor progression or total of 12 infusions.

这项第二阶段研究的目的是研究有效性、侧面 药物紫杉醇（Taxol）的作用和最大耐受剂量 治疗复发性恶性神经胶质瘤患者。 所有患者都将 在使用地塞米松药物输注紫杉醇之前进行预先用药， 治疗前苯海拉明和雷尼替丁或西咪替丁。这 药代动力学研究的目的是确定 每3次输注3小时后达到的紫杉醇浓度 几周后记录肿瘤进展或总共 12 次输注。