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

University Of California Los Angeles, Los Angeles CA

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Abstract

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)