RT, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in First-line Treatment of GBM

PHASE2CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

October 31, 2009

Study Completion Date

May 31, 2013

Conditions
Glioblastoma Multiforme
Interventions
RADIATION

Radiation therapy

Radiation therapy, 2.0 Gy daily, 5 days per week by single daily dose, to a total of 60 Gy over 6 weeks

DRUG

Temozolomide

Temozolomide 75mg/m2 by mouth daily, beginning day 1 of radiation therapy and continuing through the last day of radiation therapy

DRUG

Bevacizumab

Bevacizumab 10mg/kg IV, every 2 weeks, beginning day 1 of radiation therapy

DRUG

Bevacizumab

Bevacizumab 10mg/kg IV, every 2 weeks, beginning Week 11

DRUG

Everolimus

Everolimus 10mg by mouth daily, beginning Week 11

Trial Locations (13)

20817

Center for Cancer and Blood Disorders, Bethesda

23235

Virginia Cancer Institute, Richmond

23601

Peninsula Cancer Institute, Newport News

29210

South Carolina Oncology Associates, PA, Columbia

30501

Northeast Georgia Medical Center, Gainesville

33901

Florida Cancer Specialists, Fort Myers

35805

Clearview Cancer Institute, Huntsville

37023

Tennessee Oncology, PLLC, Nashville

40207

Consultants in Blood Disorders and Cancer, Louisville

49503

Grand Rapids Clinical Oncology Program, Grand Rapids

63017

St. Louis Cancer Care, Chesterfield

64132

Research Medical Center, Kansas City

68114

Methodist Cancer Center, Omaha

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

Novartis

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER