Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Trial of Bevacizumab in Combination With Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients With Newly-diagnosed Glioblastoma Multiforme
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such
as temozolomide, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to
kill tumor cells. Giving bevacizumab together with temozolomide and radiation therapy may
kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab
together with temozolomide and external beam radiation therapy works when given as first-line
therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma.
OBJECTIVES:
Primary
- 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.
(Pilot phase)
- To estimate the overall survival of patients treated with this regimen. (Expansion
phase)
Secondary
- To further investigate the safety and tolerability of this regimen in these patients.
(Expansion phase)
- To isolate DNA, RNA, and protein from frozen and paraffin-embedded archival tumor
samples for evaluations, such as immunohistochemical pathway profiling of vascular
endothelial growth factor (VEGF)-dependent angiogenic pathways, gene expression
microarray, and O-6 methylguanine DNA methyltransferase (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
genetic analysis.
After completion of study treatment, patients are followed up periodically.
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