RSR13 ADMINISTERED TO PATIENTS RECEIVING CRANIAL RADIATION THERAPY

RSR13 给予接受颅脑放射治疗的患者

• 批准号: 6303331
• 负责人: JAMES RUFFER
• 金额: $ 2.51万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6303331
• 关键词: clinical research; combination cancer therapy; drug screening /evaluation; glioblastoma multiforme; human subject; human therapy evaluation; neoplasm /cancer radiation therapy; oxygen; propionates

A phase II study to evaluated the efficacy and safety of repetitive daily intravenous doses of RSR13 administered to patients receiving cranial radiation therapy for glioblastoma multiforme" is a non-randomized, open-label, multi-center efficacy and safety study in patients receiving a conventional six-week course of cranial radiation therapy for glioblastoma multiforme. To be eligible for entry into the study, patients must have a histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme). The daily dose of RSR-13 will be 100 mg/kg at a concentration of 20 mg/mL administered over 30 minutes via a central venous access device. RSR-13 administration will begin on the first day of radiation therapy, occur every day of radiation therapy, and be timed so that the end of infusion occurs within 30 minutes of the start of radiation therapy. Patients will be assessed for safety, adverse events, and toxicities throughout dosing and radiation therapy and until progression of disease or death. The purpose of this study is to determine the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple daily IV infusions of RSR13 at a therapeutically relevant daily dose (100 mg/dg) administered immediately prior to radiation therapy in patients with glioblastoma multiforme.

评价向接受多形性胶质母细胞瘤的颅放射疗法的患者施用重复的每日静脉内剂量的RSR 13的功效和安全性的II期研究”是在接受多形性胶质母细胞瘤的颅放射疗法的常规六周疗程的患者中进行的非随机、开放标签、多中心功效和安全性研究。 患者必须患有组织学证实的幕上IV级星形细胞瘤（多形性胶质母细胞瘤）才有资格进入研究。 RSR-13的日剂量为100 mg/kg，浓度为20 mg/mL，通过中心静脉输液装置在30分钟内给药。 RSR-13给药将在放射治疗的第一天开始开始，放射治疗的每一天进行，并定时，以便在放射治疗开始后30分钟内结束输注。 将在整个给药和放射治疗期间评估患者的安全性、不良事件和毒性，直至疾病进展或死亡。本研究的目的是确定在多形性胶质母细胞瘤患者中放射治疗之前立即施用的治疗相关日剂量（100 mg/dg）的RSR 13的多次每日IV输注的功效、安全性、药代动力学和药效学。