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: 6114587
• 负责人: MICHAEL BOZIK
• 金额: $ 2.9万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 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/6114587
• 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.

本II期研究的目的是研究 影响和最大耐受剂量的药物紫杉醇（紫杉醇）在 治疗复发性恶性胶质瘤患者。 所有患者将被 在泰素输注前使用地塞米松进行预先给药， 苯海拉明和雷尼替丁或西咪替丁治疗前。的 药代动力学研究的目的是确定 每3小时输注一次后达到的紫杉醇浓度 直至记录到肿瘤进展或总共12次输注。