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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00290797 |
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.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent high-grade glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Bevacizumab for Patients With Recurrent High-Grade Gliomas |
Estimated Enrollment: | 88 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study. Patients are stratified according to tumor type (glioblastoma multiforme or gliosarcoma vs anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma [not otherwise specified]).
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days for up to approximately 1 year in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at the baseline, prior to each course of study treatment, and then within 2 weeks after completion of study treatment.
After completion of study treatment, patients are followed within 2 weeks.
PROJECTED ACCRUAL: A total of 88 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 proven intracranial malignant glioma, including the following:
Patients must have evidence of tumor progression by MRI or CT scan (performed within the past 14 days and while on a fixed dose of steroids for at least 5 days)
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
Recent resection of recurrent or progressive tumor allowed provided patient has recovered from effects of surgery
At least 1 week since prior noncytotoxic agents (e.g., interferon, tamoxifen, thalidomide, and tretinoin)
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Howard A. Fine, MD | NCI - Neuro-Oncology Branch |
Study ID Numbers: | CDR0000465482, NCI-06-C-0064, NCI-P6762 |
Study First Received: | February 9, 2006 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00290797 |
Health Authority: | Unspecified |
adult anaplastic oligodendroglioma adult anaplastic astrocytoma adult gliosarcoma adult glioblastoma |
adult mixed glioma adult giant cell glioblastoma recurrent adult brain tumor |
Glioblastoma Astrocytoma Bevacizumab Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Nervous System Diseases Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Neoplasms, Neuroepithelial |