Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 28, 2008

Primary Completion Date

March 23, 2017

Study Completion Date

March 23, 2017

Conditions
Brain CancerMalignant Glioma
Interventions
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."

Trial Locations (3)

10065

Memorial Sloan-Kettering Cancer Center, New York

11725

Memorial Sloan-Kettering Cancer Center at Commack, Commack

Unknown

Memoral Sloan Kettering Cancer Center, Basking Ridge

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

National Institutes of Health (NIH)

NIH

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00782756 - Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma | Biotech Hunter | Biotech Hunter