A Phase II Study of the Efficacy of Hypofractionated Radiation Therapy With Bevacizumab and Temozolomide Followed by Maintenance Temozolomide and Bevacizumab for Recurrent High-Grade Gliomas
I. To determine the overall survival (OS) for patients with recurrent high grade malignant
gliomas treated with concurrent radiation, temozolomide, and bevacizumab followed by
adjuvant temozolomide and bevacizumab.
I. Determine the impact of this regimen on neurologic symptoms via Functional Assessment of
Cancer Therapy-Brain (FACT-Br) and FACT-Fatigue scales and Eastern Cooperative Oncology
Group (ECOG) performance status.
II. Determine the safety profile of this regimen. III. Determine the progression free
survival (PFS) at 6 and 12 months (all patients) as well as at 3 months (bevacizumab-exposed
CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week
beginning on day 0. Patients also receive temozolomide orally (PO) once daily (QD) and
bevacizumab intravenously (IV) over 30-90 minutes once every 2 weeks beginning on days -3 to
0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable
ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive
temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks.
Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2-3 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Data will be analyzed using Kaplan-Meier curves. Defined as the time from first re-irradiation treatment until death from any cause.
Every 2 months or up to 90 days
Jeffrey Raizer, MD
United States: Institutional Review Board
|Northwestern University||Chicago, Illinois 60611|
|University of Chicago||Chicago, Illinois 60637|
|Edward Cancer Center||Naperville, Illinois 60540|
|Central DuPage Hospital||Winfield, Illinois 60190|
|Northwestern Lake Forest Hospital||Lake Forest, Illinois 60045|