Glioblastoma Multiforme Clinical Trial
Official title:
A Phase II Trial of Concurrent Radiation Therapy and Temozolomide Followed by Temozolomide Plus Sorafenib in the First-Line Treatment of Patients With Glioblastoma Multiforme
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.
All patients entering this study will initially undergo combined modality treatment with
concurrent radiation therapy + temozolomide. Four weeks after completing radiation therapy,
patients will begin 6 months of follow-up treatment with oral temozolomide plus sorafenib.
Combined Modality Therapy - Radiation Therapy Radiotherapy must begin within ≤ 6 weeks of
surgery. One treatment of 2.0Gy will be given daily 5 days per week for a total of 60.0Gy
over 6 weeks. Temozolomide 75mg/m2 PO will be given daily, beginning on the first day of
radiation therapy and continuing through the last day of radiation therapy.
After completion of combined modality therapy, patients will have 4 weeks without any
therapy.
Systemic Therapy Beginning 4 weeks after the completion of radiation therapy, patients will
receive 6 months of treatment with temozolomide and sorafenib. Temozolomide 150mg/m2 orally
will be administered days 1-5, and repeated every 28 days for 6 courses. Sorafenib 400mg PO
bid will be administered on days 1-28, repeated for 6 courses concurrently with temozolomide
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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