Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Trial of Bevacizumab in Combination With Sorafenib in Recurrent 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. Sorafenib may stop the growth of
tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib
may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving
bevacizumab together with sorafenib may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab
together with sorafenib works in treating patients with recurrent glioblastoma multiforme.
OBJECTIVES:
Primary
- Identify the clinical efficacy of bevacizumab and sorafenib, as measured by 6-month
progression-free survival, in patients with recurrent glioblastoma multiforme.
Secondary
- Assess time to progression of this patient population.
- Assess overall survival of this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib once daily on days 1-14 and bevacizumab IV over 30-90 minutes
on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable
toxicity.
Patients undergo blood and plasma sample collection at baseline and then periodically during
study treatment for translational research studies. Translational research studies include
analysis of circulating endothelial cells and circulating endothelial progenitor cells by
flow cytometry and measurement of angiogenic proteins in plasma by ELISA. DNA and buffy coat
are extracted and collected from the blood samples for pharmacogenetic studies.
Quality of life is assessed at baseline, prior to every other treatment course, and at the
end of treatment.
After completion of study treatment, patients are followed at 28-42 days, every 3 months for
5 years, and then annually for 10 years.
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