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
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
patients only).
OUTLINE:
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
toxicity.
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
OS
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
No
Jeffrey Raizer, MD
Principal Investigator
Northwestern University
United States: Institutional Review Board
NU 11C02
NCT01478321
November 2011
November 2014
Name | Location |
---|---|
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 |