Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

July 12, 2011

Primary Completion Date

June 30, 2015

Study Completion Date

January 31, 2017

Conditions
Malignant GliomaRecurrent Glioblastoma
Interventions
DRUG

vorinostat

Vorinostat 400mg/day will be administered on day 1 to 7 and day 15 to 21 orally on a 28 day cycle in the arm with combination of vorinostat and bevacizumab. Vorinostat will be administered orally. Vorinostat capsules should not be opened or crushed and must be administered whole.

DRUG

bevacizumab

Bevacizumab 10mg/kg will be administered on day 1 and 15 intravenously on a 28 day cycle in both arms.

Trial Locations (1)

75246

Baylor University Medical Center, Dallas

Sponsors
All Listed Sponsors
collaborator

M.D. Anderson Cancer Center

OTHER

collaborator

Genentech, Inc.

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Brain Tumor Trials Collaborative

OTHER

collaborator

Ohio State University

OTHER

collaborator

Northwestern University Feinberg School of Medicine

OTHER

collaborator

UF Health Cancer Center at Orlando Health

UNKNOWN

collaborator

Baylor Health Care System

OTHER

collaborator

MUSC Hollings Cancer Center

UNKNOWN

collaborator

University of Utah Health System

UNKNOWN

collaborator

University of Washington

OTHER

collaborator

Henry Ford Health System

OTHER

collaborator

Columbia University

OTHER

collaborator

Rush University Medical Center

OTHER

collaborator

Endeavor Health

OTHER

collaborator

The Cleveland Clinic

OTHER

collaborator

University of North Carolina, Chapel Hill

OTHER

collaborator

Washington University School of Medicine

OTHER

collaborator

Texas Oncology-Austin

UNKNOWN

lead

National Cancer Institute (NCI)

NIH