A Phase II Study of Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
Sponsor study identifier
interventional
40
1 country
3
Study Start
October 28, 2008
Actual (reported)Primary Completion
March 23, 2017
Actual (reported)Study Completion
March 23, 2017
Actual (reported)The purpose of this study is to test the safety of a new plan for treating glioblastoma. The usual first treatment for glioblastoma is to give focused radiation over 6 weeks in combination with a chemotherapy called temozolomide. In this study the radiation will be given over 2 weeks in combination with temozolomide and another drug, bevacizumab, will also be given. Our idea is that this treatment plan may attack both the tumor and the blood vessels feeding the tumor more effectively. This study will look at what effects, good or bad, this approach has on the patient and the tumor.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 23, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 28, 2008
Actual (reported)October 29, 2008
Actual (reported)October 31, 2008
Actual (reported)March 23, 2017
Actual (reported)March 23, 2017
Actual (reported)February 6, 2018
Actual (reported)Number of Participants With Adverse Events
Safety assessments and toxicity grading will follow CTCAE Version 4 Grade
through study completion, an average of 1 year
Progression Free Survival
through study completion, an average of 1 year
Neurocognitive Outcome
through study completion, an average of 1 year
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
radiotherapy (RT) in combination with temozolomide and bevacizumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordMemoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, 11725, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Antonio Omuro, MD
Memorial Sloan Kettering Cancer Center
40 participants (actual enrollment reported by the registry).
First Submitted
October 29, 2008
First Posted
October 31, 2008
Study Start
October 28, 2008
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
March 23, 2017
Actual (reported)Study Completion
March 23, 2017
Actual (reported)Last Updated
February 6, 2018
Results First Posted
February 6, 2018
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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