PHASE II SINGLE ARM TRIAL OF VEGF TRAP IN PATIENTS WITH RECURRENT TEMOZOLOMIDE-

在复发替莫唑胺患者中进行 VEGF Trap 的 II 期单臂试验 -

• 批准号: 7951575
• 负责人: TIMOTHY CLOUGHESY
• 金额: $ 0.17万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951575
• 关键词: Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Funding; Glioblastoma; Glioma; Grant; Institution; Malignant Glioma; Measures; Patients; Phase; Progression-Free Survivals; Recurrence; Research; Research Personnel; Resistance; Resources; Safety; Source; Time; Treatment Efficacy; United States National Institutes of Health; Upper arm; VEGF Trap; response; temozolomide

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. SPECIFIC AIMS: Primary Objectives: 1. To determine the therapeutic efficacy of VEGF Trap given intravenously once every two weeks in patients with temozolomide-resistant glioblastoma multiforme at first recurrence as measured by 6-month progression free survival (PFS). 2. To determine the safety profile of VEGF Trap in the treatment of malignant glioma patients in this manner. Secondary Objectives: 1. To determine the efficacy of this treatment as measured by radiographic response [RR], progression free survival [PFS], time to progression [TTP], and overall survival [OS]. 2. To characterize the single-dose and repeated-dose pharmacokinetic (PK) profiles of VEGF Trap in these patients. Exploratory Objectives: 1. To determine the therapeutic efficacy of VEGF Trap given intravenously once every two weeks in patients with temozolomide-resistant anaplastic glioma at first recurrence as measured by 6-month progression free survival (PFS)

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 具体目标： 主要目标： 1.以6个月无进展生存期(PFS)为指标，观察血管内皮细胞生长因子诱导剂(VEGFTrap)对首次复发的替莫唑胺耐药的多形性胶质母细胞瘤的疗效。 2.探讨血管内皮生长因子诱导剂治疗恶性胶质瘤的安全性。 次要目标： 1.通过放射学反应[RR]、无进展生存期[PFS]、进展时间[TTP]和总生存期[OS]来确定该治疗方案的疗效。 2.研究血管内皮细胞生长因子陷阱单次给药和多次给药的药代动力学特征。 探索性目标： 1.以6个月无进展生存期(PFS)为指标，观察血管内皮细胞生长因子诱导剂(VEGFTrap)对替莫唑胺耐药的间变性胶质瘤首次复发的疗效。