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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00892177 |
RATIONALE: Dasatinib 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 block the growth of the tumor by blocking blood flow to the tumor. Giving dasatinib together with bevacizumab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of dasatinib when given together with bevacizumab and to see how well it works in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Biological: bevacizumab Drug: dasatinib Genetic: fluorescence in situ hybridization Genetic: reverse transcriptase-polymerase chain reaction Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: quality-of-life assessment |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study of Dasatinib/Bevacizumab in Recurrent Glioblastoma |
Estimated Enrollment: | 95 |
Study Start Date: | May 2009 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of dasatinib. Patients are stratified according to ECOG performance status (0 vs 1 vs 2), and phase I dose levels (-1 vs 0 vs 1 vs 2 vs 3 or Alt 1 vs Alt 2).
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed by FACT-Br questionnaire at baseline and prior to every other course. Tissue samples are collected at baseline for biomarker studies and assessed by IHC, RT-PCR, and FISH. Patients undergo dynamic contrast-enhanced MRI at baseline, day 3 of course 1, and day 1 of course 2.
After completion of study therapy, patients are followed periodically for up to 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
PATIENT CHARACTERISTICS:
No uncontrolled hypertension (systolic BP of > 150 mm Hg or diastolic BP > 100 mm Hg on antihypertensive medications)
No immunocompromised patients (other than that related to the use of corticosteroids)
PRIOR CONCURRENT THERAPY:
No prior intratumoral therapy, stereotactic radiosurgery, or interstitial brachytherapy except for the following:
At least 7 days since prior drugs that have a risk of causing Torsades de Pointes, including any of the following:
No concurrent therapeutic anticoagulation with warfarin, except low-dose warfarin for venous or arterial access devices, provided INR < 1.5
Study ID Numbers: | CDR0000641746, NCCTG-N0872 |
Study First Received: | May 1, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00892177 History of Changes |
Health Authority: | Unspecified |
adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult mixed glioma |
recurrent adult brain tumor adult anaplastic oligodendroglioma adult oligodendroglioma adult anaplastic astrocytoma |
Glioblastoma Astrocytoma Bevacizumab Central Nervous System Neoplasms Protein Kinase Inhibitors Angiogenesis Inhibitors Recurrence Brain Neoplasms Neuroectodermal Tumors |
Dasatinib Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Glioma Glioblastoma Multiforme Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Bevacizumab Protein Kinase Inhibitors Neoplasms by Site Neoplasms, Germ Cell and Embryonal Dasatinib Therapeutic Uses Glioma Angiogenesis Modulating Agents |
Growth Inhibitors Nervous System Neoplasms Neoplasms by Histologic Type Astrocytoma Growth Substances Nervous System Diseases Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Neuroectodermal Tumors Neoplasms Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |