To determine the maximum tolerated dose of ABT 510 when administered concurrent with radiation therapy 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 this therapy. 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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
ABT 510 (TSP-1 mimetic peptide) is a parenterally available nonapeptide analog of the heptapeptide and is a potent inhibitor of angiogenesis. ABT 510 competes with TSP-1 for binding to endothelial cells, but the exact mechanism of anti-angiogenesis is unknown. ABT 510 is administered by SQ injection. The starting dose of ABT 510 will be 20mg once daily (QD) SQ. Doses will be escalated by approximately 50% increments in consecutive cohorts of 3-6 patients until maximum tolerated dose is achieved.
University of Alabama at Birmingham
Birmingham, Alabama, United States
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.
Time frame: up to 2 years
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