Phase I Portion of Phase I/II Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma

PHASE1TerminatedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

December 18, 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."

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER