Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
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|ClinicalTrials.gov Identifier: NCT00782756|
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : February 6, 2018
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Brain Cancer Malignant Glioma||Other: radiotherapy (RT) in combination with temozolomide and bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma|
|Actual Study Start Date :||October 28, 2008|
|Actual Primary Completion Date :||March 23, 2017|
|Actual Study Completion Date :||March 23, 2017|
Experimental: RT, with temozolomide and bevacizumab
This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
Other: radiotherapy (RT) in combination with temozolomide and bevacizumab
Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.
Post RT therapy: Bevacizumab 10mg/kg IV every two weeks. Temozolomide 150-200mg/m2 daily for 5 consecutive days will be given on 28 day cycles.
Follow up: CBC weekly, comprehensive panel and urinalysis monthly, blood pressure every other week. Neurological/physical examination monthly. Gd-enhanced MRI with perfusion every 2 cycles. Neurocognitive testing (approximately 4months post RT, 1 year after diagnosis and then annually in long term survivors). Blood sample for correlative studies monthly.
- Number of Participants With Adverse Events [ Time Frame: through study completion, an average of 1 year ]Safety assessments and toxicity grading will follow CTCAE Version 4 Grade
- Progression Free Survival [ Time Frame: through study completion, an average of 1 year ]
- Neurocognitive Outcome [ Time Frame: through study completion, an average of 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782756
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center at Commack|
|Commack, New York, United States, 11725|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Antonio Omuro, MD||Memorial Sloan Kettering Cancer Center|