PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

April 30, 2014

Study Completion Date

June 30, 2015

Conditions
Glioblastoma Multiforme
Interventions
DRUG

PPX (CT2103)

XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.

DRUG

Temozolomide

XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum

Trial Locations (9)

13210

SUNY Medical Center, Syracuse

17033

PSU, Hershey

19107

Thomas Jefferson University Cancer Center, Philadelphia

75235

UT Southwestern Cancer Center, Dallas

92093

UCSD Cancer Center, La Jolla

98109

University of Washington, Seattle

04074

Maine Medical Center, Scarborough

01605

UMASS Medical Center Cancer Center, Worcester

02906

Rhode Island Hospital, Providence

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Rhode Island Hospital

OTHER

collaborator

Milton S. Hershey Medical Center

OTHER

collaborator

University of Washington

OTHER

collaborator

University of Massachusetts, Worcester

OTHER

collaborator

MaineHealth

OTHER

collaborator

University of California, San Diego

OTHER

collaborator

Thomas Jefferson University

OTHER

lead

Brown University

OTHER