Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma
The goal of this Phase I portion of this clinical research study is to find the highest tolerable dose of bevacizumab with or without vorinostat, that can be given to patients with malignant gliomas. The safety of these drug combinations will also be studied.
The goal of this Phase II part of this clinical research study is to learn if bevacizumab when given with or without vorinostat can help to control malignant gliomas. The safety of these drug combinations will also be studied.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma|
- Progression Free Survival (PFS) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2011|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Vorinostat + Bevacizumab
Phase I Vorinostat orally days 1 - 7 and days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 + 15 of 28 day cycle.
Phase I: 400 mg by mouth once a day on days 1 to 7, and days 15 to 21 in a 28 day cycle.
Other Names:Drug: Bevacizumab
Phase I: 10 mg/kg by vein on day 1 and 15 of a 28 day cycle.
Experimental: Bevacizumab MTD
Phase II Bevacizumab Alone
Phase II: 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
Experimental: Bevacizumab + Vorinostat
Phase II Bevacizumab + Vorinostat
Phase II: 400 mg/day by mouth on days 1 to 7 and days 15 to 21 of a 28 day cycle.
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|Contact: Marta Penas-Prado, MD||713-792-2883|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Marta Penas-Prado, MD||UT MD Anderson Cancer Center|