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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00268359 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan may kill more tumors cells.
PURPOSE: This phase II trial is studying the side effects of bevacizumab and how well giving bevacizumab together with irinotecan works in treating patients with recurrent or refractory gliomas.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Biological: bevacizumab Drug: irinotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Bevacizumab in Combination With Irinotecan for Malignant Gliomas |
Estimated Enrollment: | 68 |
Study Start Date: | May 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive bevacizumab and irinotecan hydrochloride every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary grade 3 or 4 malignant glioma of 1 of the following types:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | James J. Vredenburgh, MD | Duke University |
Study ID Numbers: | CDR0000450832, DUMC-6771-05-1R0, GENENTECH-AVF3311s |
Study First Received: | December 20, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00268359 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult glioblastoma |
adult gliosarcoma recurrent adult brain tumor adult giant cell glioblastoma |
Glioblastoma Astrocytoma Irinotecan Central Nervous System Neoplasms Bevacizumab Angiogenesis Inhibitors Recurrence |
Camptothecin Brain Neoplasms Oligodendroglioma Glioma Gliosarcoma Antineoplastic Agents, Phytogenic Nervous System Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Nervous System Diseases Irinotecan Enzyme Inhibitors Central Nervous System Neoplasms Bevacizumab Angiogenesis Inhibitors |
Camptothecin Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic Nervous System Neoplasms |