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

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 具体目标： 主要目的： 1.通过6个月无进展生存期（PFS）测定首次复发时替莫唑胺耐药多形性胶质母细胞瘤患者静脉给予VEGF Trap每2周一次的疗效。 2.确定VEGF Trap以这种方式治疗恶性胶质瘤患者的安全性特征。 次要目的： 1.通过放射学缓解[RR]、无进展生存期[PFS]、至疾病进展时间[TTP]和总生存期[OS]测定该治疗的疗效。 2.描述这些患者中VEGF Trap单次给药和重复给药的药代动力学（PK）特征。 探索性目的： 1.通过测量6个月无进展生存期（PFS），确定每2周一次静脉给予VEGF Trap治疗首次复发的替莫唑胺耐药间变性胶质瘤患者的疗效

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)