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High-Grade Gliomas clinical trials

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NCT ID: NCT00393094 Terminated - High-Grade Gliomas Clinical Trials

Bevacizumab and Irinotecan to Treat Brain Tumors

Start date: September 2006
Phase: Phase 2
Study type: Interventional

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