A Phase I Study of ABT 510 for Newly Diagnosed Glioblastoma Multiforme
|ClinicalTrials.gov Identifier: NCT00584883|
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : May 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor||Drug: ABT 510||Phase 1|
- To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme.
- To determine the duration of disease free survival and overall survival associated with this therapy.
- 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).
- 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 (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of ABT 510 and Concurrent Temozolomide and Radiotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Drug: ABT 510
- All patients enrolled in this study will be statistically characterized for baseline and disease characteristics using descriptive statistics for continuous measures. [ Time Frame: up to 2 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584883
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Louis B Nabors, MD||University of Alabama at Birmingham|