Phase II Trial of Bevacizumab in Combination With Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients With Newly-diagnosed Glioblastoma Multiforme
- To investigate the safety and tolerability of bevacizumab in combination with
temozolomide and external beam fractionated regional radiotherapy as first-line
treatment in patients with newly diagnosed glioblastoma multiforme or gliosarcoma.
- To estimate the overall survival of patients treated with this regimen. (Expansion
- To further investigate the safety and tolerability of this regimen in these patients.
- To isolate DNA, RNA, and protein from frozen and paraffin-embedded archival tumor
samples for evaluations, such as immunohistochemical pathway profiling of
VEGF-dependent angiogenic pathways, gene expression microarray, and MGMT promoter
methylation status to define important molecular features of treatment response.
OUTLINE: This is a multicenter study.
Patients undergo external beam fractionated regional radiotherapy once daily 5 days a week
for 6 weeks and receive concurrent oral temozolomide once daily for 6 weeks. Patients also
receive bevacizumab IV over 30-90 minutes every 2 weeks beginning on the first day of
radiotherapy and continuing in the absence of disease progression or unacceptable toxicity.
Beginning 2-5 weeks after completion of radiotherapy, patients receive oral temozolomide on
days 1-5. Treatment with temozolomide repeats every 28 days for up to 24 courses in the
absence of disease progression or unacceptable toxicity.
Blood and frozen and paraffin-embedded tumor tissue samples are collected for biomarker and
After completion of study treatment, patients are followed up periodically.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Albert Lai, MD
Ronald Reagan UCLA Medical Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|