Bevacizumab and Irinotecan to Treat Brain Tumors
Stopped early · Phase 2
Conditions studied: High-Grade Gliomas
In brief
Background: * Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. It has shown activity against human brain tumors in laboratory tests and human clinical trials. * Irinotecan causes damage to the deoxyribonucleic acid (DNA) in cancer cells so that the cells cannot reproduce or repair themselves. It is approved for treating patients with colorectal cancer. * Bevacizumab and irinotecan in combination are more effective against colon cancer than either drug alone. Objectives: * To determine the safety of bevacizumab and irinotecan and any side effects associated with the combination of the two drugs when given to patients with high grade gliomas. * To determine if the combination of bevacizumab and irinotecan can help patients with brain tumors that have grown after treatment with bevacizumab alone. Eligibility: -Patients 18 years of age and older who have been treated on National Cancer Institute (NCI) trial 06-C-0064 (NCT00271609), "Bevacizumab Alone for Recurrent Gliomas," and whose tumor has progressed. Design: Participants receive infusions of bevacizumab and irinotecan through a vein once every 2 weeks in 4-week treatment cycles, plus the following procedures: * History, physical and neurological examinations every 2 weeks for the first treatment cycle and then every 4 weeks * Magnetic Resonance Imaging (MRI) scan of the head every 4 weeks. * Routine lab every week. * Quality-of-life questionnaire every 4 weeks
Key facts
- Study ID
- NCT00393094
- Run by
- National Cancer Institute (NCI)
- People needed
- 31
- Starts
- 2006-09-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2012-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Concurrent use of other standard chemotherapeutics or investigative agents.
- 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.
- 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
- Core biopsy within 7 days prior to day (D)1 therapy
- Patients with clinically significant cardiovascular disease:
- History of cerebrovascular accident (CVA) within 6 months
- Uncontrolled hypertension (greater than 150/100 mmHg)
- Myocardial infarction or unstable angina within 6 months
- New York heart association grade II or greater congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Unstable angina pectoris
- Clinically significant peripheral vascular disease
- Clinical evidence of bleeding diathesis or coagulopathy.
- Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies.
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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