Radiation Therapy and Temozolomide Followed by Temozolomide Plus Sorafenib for Glioblastoma Multiforme
Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
Summary
The mechanism of action of sorafenib makes it an interesting drug to investigate in the
treatment of patients with glioblastoma multiforme. Efficacy of agents with anti-angiogenic
activity has already been demonstrated and the PDGF receptor target may also be pertinent in
glioblastoma. The combination of temozolomide plus sorafenib has been investigated previously
in the treatment of patients with advanced melanoma. The combination was generally well
tolerated; in previously untreated patients, a standard dose of sorafenib (400mg PO bid) was
administered with temozolomide 150mg/m2 PO daily for 5 days, repeated every 28 days (23).
In this multicenter phase II study, patients with newly diagnosed glioblastoma will receive
standard treatment, including initial debulking surgical resection (if feasible) followed by
high-dose radiation therapy with concurrent temozolomide. After completion of radiation
therapy, patients will continue treatment with temozolomide (150mg/m2 days 1-5) and sorafenib
(400mg PO bid daily), repeated at 28-day intervals for 6 cycles.