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: Baseline until disease progression or death due to any cause, assessed at least 4 weeks after surgery to begin treatment in the adaptive randomized portion of the trial every 8 weeks up to 28 days after last dose (follow-up . ] [ Designated as safety issue: No ]PFS is time measured in months to disease progression. Participants must at least 4 weeks after surgery to begin treatment in the adaptive randomized Phase 2 portion of the trial. PFS in participants in the surgical arm determined from the date of randomization to the treatment arms and not from the date of registration in the trial.
- Maximum tolerated dose (MTD) [ Time Frame: Assessed with each 28 day cycle ] [ Designated as safety issue: Yes ]MTD defined as the dose level at which 1/6 patients experience dose limiting toxicity (DLT), and that MTD dose used for the Phase II part of the study.
|Study Start Date:||July 2011|
|Estimated Primary Completion Date:||July 2016 (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.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266031
|Contact: MD Anderson Cancer Center||(713) 792-6600|
|Contact: Marta Penas-Prado, MD||713-792-2883|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Brain & Spine Center 713-792-6600|
|Principal Investigator:||Marta Penas-Prado, MD||UT MD Anderson Cancer Center|
|Study Chair:||Vinay Puduvalli, MD||Brain Tumor Trials Collaborative, and Ohio State University|