PHASE II REPETITIVE IV DOSES OF RSR13 TO PT RECEIVING CRANIAL RADIATI
PHASE II REPETITIVE IV DOSES OF RSR13 TO PT RECEIVING CRANIAL RADIATI
批准号:
6309872
负责人:
GLENN J LESSER
金额:
$2.42万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-12-01 至 2001-02-28
关键词:
astrocytoma clinical research cytotoxicity drug administration rate /duration drug adverse effect drug screening /evaluation glioblastoma multiforme human subject human therapy evaluation injection /infusion intravenous administration longitudinal human study neoplasm /cancer chemotherapy neoplasm /cancer radiation therapy neoplastic process pharmacokinetics propionates sickling inhibitor
中文摘要
本研究的目的是确定在多形性胶质母细胞瘤患者中在放射疗法之前立即施用的治疗相关日剂量(100 mg/kg)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。这种肿瘤几乎无法通过手术、放疗或化疗治愈。 这项研究旨在寻找RSR 13可以改善放射治疗这种类型肿瘤的结果的证据,并评估RSR 13与放射治疗一起使用时的安全性和耐受性。 RSR 13是一种研究药物,可增加从血液释放到组织中的氧气量。 肿瘤中缺氧会降低放射治疗的有效性,因此,RSR 13可以通过增加向肿瘤的氧气输送来提高放射治疗的有效性。
英文摘要
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/kg) administered immediately prior to radiation therapy in patients with glioblastoma multiforme. This tumor is almost never cured with surgery, radiation therapy or chemotherapy. This research study is designed to look for evidence that RSR13 may improve results of radiation therapy for treatment of this type of tumor and to evaluate the safety and tolerance of RSR13 when given with radiation therapy. RSR13 is an investigational drug that increases the amount of oxygen released from the blood into the tissues. Lack of oxygen in a tumor can reduce the effectiveness of radiation therapy, therefore, RSR13 may improve the effectiveness of radiation therapy by increasing oxygen delivery to the tumor.
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