Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM)
The goal of this clinical research study is to find the highest tolerable dose of the combination vorinostat and erlotinib, with or without temozolomide, that can be given to patients with malignant gliomas. The safety of these drug combinations will also be studied.
|Study Design:||Allocation: 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 Vorinostat, Erlotinib and Temozolomide in Adults With Recurrent Glioblastoma Multiforme|
- Maximum Tolerated Dose (MTD) [ Time Frame: Evaulated with each 28 day (+2 days) cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2011|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Vorinostat + Erlotinib + Temozolomide
Phase I Vorinostat with Erlotinib + Temozolomide
200 mg twice daily by mouth on Days 1-7, 15-21 of each 28 day cycle.
Other Names:Drug: Erlotinib
Starting Dose 200 mg by mouth daily on Days 1-21 of 28 day cycle. For patients on enzyme inducing anticonvulsants (EIACs), starting dose of 400 mg.
Other Names:Drug: Temozolomide
125 mg/m2 by mouth daily on days 1-7, 15-21 of each 28 day cycle.
Other Name: Temodar
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||John DeGroot, MD||UT MD Anderson Cancer Center|