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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00667394 |
RATIONALE: Tandutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving tandutinib together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving tandutinib together with bevacizumab and to see how well it works in treating patients with recurrent high-grade glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Biological: bevacizumab Drug: tandutinib Procedure: quality-of-life assessment |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase 2 Trial of Tandutinib in Combination With Bevacizumab for Patients With Recurrent High-Grade Gliomas |
Estimated Enrollment: | 80 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral tandutinib twice daily for 2 weeks. Patients then receive oral tandutinib twice daily in weeks 1-4 and bevacizumab IV over 30-90 minutes in weeks 1 and 3. Treatment with tandutinib and bevacizumab repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients complete a health-related quality of life questionnaire.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed intracranial malignant glioma, including any of the following:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Evidence of significant recent hemorrhage on mandatory CT scan (defined as 1 cm or more of acute blood) of the brain within 7 days of patient accrual with the following exceptions:
Clinically significant cardiovascular disease including:
Active cardiac disease, as defined by the following:
Known or suspected primary muscular or neuromuscular disease (e.g., muscular dystrophy or myasthenia gravis)
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
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 |
Principal Investigator: | Howard A. Fine, MD | NCI - Neuro-Oncology Branch |
Study ID Numbers: | CDR0000594111, NCI-08-C-0101, P07260 |
Study First Received: | April 25, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00667394 History of Changes |
Health Authority: | Unspecified |
adult anaplastic astrocytoma adult diffuse astrocytoma adult pilocytic astrocytoma adult subependymal giant cell astrocytoma adult anaplastic ependymoma adult ependymoma adult myxopapillary ependymoma adult subependymoma |
adult anaplastic oligodendroglioma adult brain stem glioma adult oligodendroglioma adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult mixed glioma recurrent adult brain tumor |
Glioblastoma Astrocytoma Bevacizumab Central Nervous System Neoplasms Angiogenesis Inhibitors Ependymoma 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 Physiological Effects of Drugs Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Neoplasms Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Growth Inhibitors Angiogenesis Modulating Agents Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |