Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) for Recurrent Glioblastoma Multiforme (GBM)
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|ClinicalTrials.gov Identifier: NCT01067469|
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : October 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Brain Cancer Glioblastoma||Drug: Standard Dose Bevacizumab Drug: Low Dose Bevacizumab Drug: Lomustine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Trial of Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) In Adults With Recurrent Glioblastoma Multiforme|
|Study Start Date :||January 2010|
|Primary Completion Date :||October 2016|
|Study Completion Date :||October 2016|
Experimental: Standard Dose Bevacizumab
Bevacizumab 10 mg/kg by vein (IV) over 90 minutes on Days 1, 15, and 29 of 6 week cycle.
Drug: Standard Dose Bevacizumab
10 mg/kg by vein (IV) over 90 minutes on Days 1, 15, and 29 of 6 week cycle.
Experimental: Low Dose Bevacizumab + Lomustine
Bevacizumab 5 mg/kg IV over 90 minutes on Day 1 and 22 (every 3 weeks) of 6 week cycle. Lomustine starting dose of 75 mg/m2 administered orally at sleep time on Day 3 of every 6 week cycle.
Drug: Low Dose Bevacizumab
5 mg/kg IV over 90 minutes on Day 1 and 22 (every 3 weeks) of 6 week cycle.
Other Names:Drug: Lomustine
Starting dose of 75 mg/m2 administered orally at sleep time on Day 3 of every 6 week cycle.
- Progression free survival (PFS) [ Time Frame: Baseline to 6 months minimally, progression documented after 6 week treatment cycle ]Number of participants with no disease progression as measured by magnetic resonance imaging (MRI) scans. Participants followed by MRI scans, as used for baseline tumor measurements, and removed from study if progression is documented after any cycle of treatment. PFS determined from date of registration in the trial and not date of randomization into chemotherapy arms (i.e. after surgery for resection of recurrent tumor).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067469
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||John DeGroot, MD||M.D. Anderson Cancer Center|