Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM)

PHASE2TerminatedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

June 16, 2014

Study Completion Date

June 16, 2014

Conditions
Glioblastoma MultiformeGliosarcoma
Interventions
DRUG

Gliadel

Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection.

RADIATION

Radiation Therapy

At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy.

DRUG

Avastin

"Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively.~Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days."

DRUG

Temodar

At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation. In addition, beginning 2-3 weeks after the last radiation therapy, but not greater than 8 weeks, patients will be treated with 5 day Temodar (200 mg/ m2).

Trial Locations (1)

27710

The Preston Robert Tisch Brain Tumor Center, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

Eisai Inc.

INDUSTRY

lead

Duke University

OTHER