A Phase I Study of ABT 510 and Concurrent Temozolomide and Radiotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme
1. To describe the toxicity associated with this regimen in adult patients with newly
diagnosed glioblastoma multiforme.
2. To determine the duration of disease free survival and overall survival associated with
3. Evaluate thrombospondin 1 (TSP-1) and 2 (TSP-2) in tumor vs. corresponding normal
tissue using quantitative real time Polymerase Chain Reaction (Q-RT-PCR).
4. Determine the effect of ABT 510 on tumor permeability and tumor blood volume as
measured by non-invasive Magnetic Resonance Imaging (MRI).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
All patients enrolled in this study will be statistically characterized for baseline and disease characteristics using descriptive statistics for continuous measures.
The primary outcome for the study was safety and to define the MTD (max tolerated dose). Also, survival was to be measured but the study was not powered to statistically have significance for that measure.
up to 2 years
Louis B Nabors, MD
University of Alabama at Birmingham
United States: Food and Drug Administration
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|