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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Weill Medical College of Cornell University |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00595322 |
This is a pilot study. The goal of this study is to test whether Bevacizumab is safe enough in patients with brain tumors so that a larger study can be conducted. This study will also give us some information about whether the combination of Bevacizumab and radiation has potential to become an effective treatment for regrowing brain tumors.
Bevacizumab is an experimental drug that blocks a molecule called VEGF that is found in high amounts in malignant gliomas. VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In studies with laboratory animals, Bevacizumab slowed the growth of several different types of human cancer cells by blocking the effects of VEGF. There is also evidence that Bevacizumab enhances the effects of radiation on tumor cell
Condition | Intervention |
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Brain Cancer Recurrent Malignant Gliomas Primary Brain Tumor |
Other: bevacizumab and radiation (IMRT) |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | Safety of Bevacizumab in the Radiation Treatment of Recurrent Malignant Glioma: A Pilot Study |
Estimated Enrollment: | 25 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
bevacizumab and radiation (IMRT)
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Other: bevacizumab and radiation (IMRT)
bevacizumab 10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (cycle defined as 28 days). If the tumor volume remains < 40 cc, the patient will undergo stereotactic radiotherapy with IMRT (30Gy) beginning anywhere from day 7-10 of cycle 2 (5 doses of 6 Gy over 2 and a half weeks)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Philip Gutin, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Philip Gutin, MD ) |
Study ID Numbers: | 05-092 |
Study First Received: | January 7, 2008 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00595322 |
Health Authority: | United States: Institutional Review Board |
Bevacizumab Radiation Treatment Brain Cancer |
Neuroectodermal Tumors Brain Neoplasms Neoplasms, Germ Cell and Embryonal Neuroepithelioma Central Nervous System Diseases Bevacizumab |
Central Nervous System Neoplasms Glioma Brain Diseases Nervous System Neoplasms Recurrence Neoplasms, Glandular and Epithelial |
Disease Attributes Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Nervous System Diseases Neoplasms, Nerve Tissue Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Pathologic Processes Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Neoplasms, Neuroepithelial |