Radiation Therapy and Temozolomide Followed by Temozolomide Plus Sorafenib for Glioblastoma Multiforme

Inclusion Criteria

• •1. Histologically confirmed intracranial glioblastoma multiforme (WHO grade 4).
• •2. Patients who have had partial or complete surgical debulking are eligible, as are those with inoperable glioblastoma.
• •3. No previous treatment for glioblastoma except for previous surgical debulking (i.e. no previous radiotherapy, local chemotherapy, or systemic therapy).
• •4. ECOG performance status 0 or 1 (See Appendix C)
• •5. Age ≥ 18 years
• •6. Adequate bone marrow function: hemoglobin ≥ 9.0g/dL; ANC ≥ 1500/μL; platelet count ≥ 100,000/μL.
• •7. Adequate liver function
• •* Total bilirubin ≤ 1.5 x ULN
• •* ALT and AST ≤ 2.5 x ULN
• •8. Serum creatinine \< 1.5 x ULN
• •9. Women of child-bearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Women must agree to not breast feed while receiving study treatment.
• •10. Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control) while receiving study treatment. Women should use adequate birth control for at least 3 months after the last administration of sorafenib.
• •11. INR \< 1.5 or PT/PTT within normal limits in patients not receiving anticoagulation. However, patients receiving anticoagulation treatment with an agent such as warfarin or heparin are also eligible. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
• •12. Patients must have the ability to understand and the willingness to sign written informed consent. A signed informed consent must be obtained prior to any study-specific procedures.