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Sponsors and Collaborators: |
University of California, Davis National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00795665 |
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 carmustine, 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 carmustine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with carmustine works in treating patients with relapsed or progressive high-grade glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: bevacizumab Drug: carmustine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Bevacizumab (Avastin) and BCNU for Treatment of Relapsed, High Grade Gliomas |
Estimated Enrollment: | 20 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive bevacizumab IV on days -7, 8, 22, 36, and 50 of course 1 and on days 8, 22, 36, and 50 of all subsequent courses. Patients also receive carmustine IV over 4 hours on day 1. Treatment repeats every 56 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of one of the following:
PATIENT CHARACTERISTICS:
Urine protein:creatinine ratio < 1.0 OR proteinuria < 2+ by urine dipstick
PRIOR CONCURRENT THERAPY:
United States, California | |
University of California Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 |
Principal Investigator: | Robert T. O'Donnell, MD, PhD | University of California, Davis |
Responsible Party: | University of California Davis Cancer Center ( Robert T. O'Donnell ) |
Study ID Numbers: | CDR0000626157, UCD-208, UCDCC-208, 200715706-2, GENENTECH-UCD-208 |
Study First Received: | November 20, 2008 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00795665 |
Health Authority: | Unspecified |
adult anaplastic astrocytoma adult glioblastoma adult gliosarcoma adult giant cell glioblastoma |
adult anaplastic oligodendroglioma adult mixed glioma recurrent adult brain tumor |
Glioblastoma Astrocytoma Carmustine 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 Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Nervous System Diseases Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents |