Phase II Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2008

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
GlioblastomaGliosarcoma
Interventions
DRUG

Temozolomide

"Groups 1 \& 2: 75 mg/m\^2 Once Daily by Mouth During Radiation; 4 Weeks after Completion of Radiation, 150-200 mg/m\^2 Once Daily by Mouth Days 1-5 of 1st 28-Day Cycle, then 75 mg/m\^2 Once Daily by Mouth Days 1-5 for Subsequent 28-Day Cycles.~Groups 3 \& 4: 75 mg/m\^2 Once Daily by Mouth During Radiation; 4 Weeks after Completion of Radiation, 75-100 mg/m\^2 Once Daily by Mouth Days 1-21 every 28-Day Cycle."

RADIATION

Radiation

Total of 60 Gy delivered over 30 Days (approximately 6 weeks).

DRUG

Sorafenib

"Group 1: 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth.~Group 2: 200 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth.~Group 3: 200 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 200 mg Twice Daily by Mouth.~Group 4: 400 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth."

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER