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

Summary

The goal of this Phase I portion of this clinical research study is to find the highest tolerable dose of bevacizumab with or without vorinostat, that can be given to patients with malignant gliomas. The safety of these drug combinations will also be studied.

The goal of this Phase II part of this clinical research study is to learn if bevacizumab when given with or without vorinostat can help to control malignant gliomas. The safety of these drug combinations will also be studied.

Conditions

• Malignant Glioma
• Recurrent 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  collaborator OTHER

• Genentech, Inc.

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Brain Tumor Trials Collaborative

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Northwestern University Feinberg School of Medicine

  collaborator OTHER

• UF Health Cancer Center at Orlando Health

  collaborator UNKNOWN

• Baylor Health Care System

  collaborator OTHER

• MUSC Hollings Cancer Center

  collaborator UNKNOWN

• University of Utah Health System

  collaborator UNKNOWN

• University of Washington

  collaborator OTHER

• Henry Ford Health System

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Rush University Medical Center

  collaborator OTHER

• Endeavor Health

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Texas Oncology-Austin

  collaborator UNKNOWN

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Mark R Gilbert, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-07-12

Primary Completion

2015-06-30

Completion

2017-01-31

FDA Drug

Yes

Countries

• United States

Study Locations