Bevacizumab for Recurrent Malignant Glioma

Summary

Background: Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. Inhibiting the formation of these blood vessels may slow or stop disease progression by diminishing the supply of life-sustaining nutrients and oxygen the blood delivers to the tumor. Bevacizumab is approved for treating colorectal cancer and has shown activity against brain tumor cells in laboratory and animal tests. Objectives: To examine the safety and side effects of bevacizumab in patients with recurrent brain tumors. To determine the anti-tumor activity of bevacizumab in patients with recurrent brain tumors. Eligibility: Patients 18 years of age and older with a brain tumor that continues to grow after receiving standard treatments. Design: Patients complete the following procedures during the study: * Infusions of bevacizumab through a vein once every 2 weeks in 4-week treatment cycles. * Positron emission tomography (PET) scan before the first dose of bevacizumab, at the end of the first treatment cycle, and as needed after that. * Magnetic resonance imaging (MRI) scan before the first dose of bevacizumab, within 48-96 hours after the first dose of bevacizumab in the first treatment cycle, and then every 4 weeks. One tube of blood for research is collected at the time of each MRI scan to look at specific cells. * Physical and neurological examinations every 2 weeks for the first treatment cycle and then every 4 weeks. * Quality-of-life questionnaires every 4 weeks.

Timeline

Start

2005-12

Primary completion

2011-03

Completion

2014-02

Outcome

Missed primary endpoint

paper Single-agent bevacizumab produces significant radiographic response in patients with recurrent anaplastic glioma but did not meet the 6-month progression-free survival endpoint. PMID 21865400 ↗

Publications

• Background Barker D, Wright E, Nguyen K, Cannon L, Fain P, Goldgar D, Bishop DT, Carey J, Baty B, Kivlin J, et al. Gene for von Recklinghausen neurofibromatosis is in the pericentromeric region of chromosome 17. Science. 1987 May 29;236(4805):1100-2. doi: 10.1126/science.3107130.
• Background Bigner SH, Bjerkvig R, Laerum OD. DNA content and chromosomal composition of malignant human gliomas. Neurol Clin. 1985 Nov;3(4):769-84.
• Background Moss AR. Occupational exposure and brain tumors. J Toxicol Environ Health. 1985;16(5):703-11. doi: 10.1080/15287398509530780.
• Results Kreisl TN, Zhang W, Odia Y, Shih JH, Butman JA, Hammoud D, Iwamoto FM, Sul J, Fine HA. A phase II trial of single-agent bevacizumab in patients with recurrent anaplastic glioma. Neuro Oncol. 2011 Oct;13(10):1143-50. doi: 10.1093/neuonc/nor091. Epub 2011 Aug 24.
• Odia Y, Shih JH, Kreisl TN, Fine HA. Bevacizumab-related toxicities in the National Cancer Institute malignant glioma trial cohort. J Neurooncol. 2014 Nov;120(2):431-40. doi: 10.1007/s11060-014-1571-6. Epub 2014 Aug 7.

Drugs

Indications