Bevacizumab for Recurrent Malignant Glioma
Completed · Phase 2
Conditions studied: Recurrent High-Grade Gliomas, Malignant Gliomas
In brief
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.
Key facts
- Study ID
- NCT00271609
- Run by
- National Cancer Institute (NCI)
- People needed
- 88
- Starts
- 2005-12-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2014-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patients who, in the view of the treating physician,
- have significant active cardiac,
- hepatic,
- renal,
- or psychiatric diseases are ineligible.
- No concurrent use of other standard chemotherapeutics or investigative agents.
- Patients known to have a malignancy that has required treatment in the last 12 months and/or is expected to require treatment in the next 12 months (except non-melanoma skin cancer or carcinoma in-situ in the cervix).
- Patients who have an active infection.
- Pregnant (positive pregnancy test) or nursing women.
- Both fertile men and women must agree to use adequate contraceptive measures during study therapy and for at least 6 months after the completion of bevacizumab therapy.
- Patients who have any disease that will obscure toxicity.
- Patients with evidence of acute intracranial/intratumoral hemorrhage on pre-study CT scan.
- Concurrent anti-coagulation or anti-platelet medication (including aspirin, -non-steroidal anti-inflammatories,
- cyclooxygenase 2 (COX-2) inhibitors).
- Serious or non-healing wound,
- ulcer
- or bone fracture
- History of abdominal fistula,
- gastrointestinal perforation
- or intra-abdominal abscess within 28 days
- Invasive procedures defined as follows:
- Major surgical procedure,
- open biopsy
- or significant traumatic injury within 28 days prior to Day 1 therapy
- Anticipation of need for major surgical procedures during the course of the study
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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