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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborators: |
Brigham and Women's Hospital Massachusetts General Hospital Genentech Novartis |
| Information provided by: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00859222 |
Purpose
The purpose of this research study is to determine the amount of LBH589 that can be given to people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA approved for use in patients with colorectal cancer and has been studied extensively in other types of solid tumors. The combination of LBH589 and bevacizumab has no yet been studied but information from other studies suggests that the combination may help prevent the growth of the participant's tumor.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Glioma |
Drug: LBH589 Drug: bevacizumab |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase I/II Study of LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma |
| Estimated Enrollment: | 67 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
PHASE I Inclusion Criteria (the following modifications to the general eligibility criteria apply to Phase I patients only):
PHASE II Inclusion Criteria (phase II patients must meet the general eligibility criteria as well as the following):
Exclusion Criteria:
Contacts and Locations| Contact: Patrick Y. Wen, MD | 617-632-2166 |
| United States, Illinois | |
| Northwestern University | Not yet recruiting |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: Jeffrey Raizer, M.D. | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Lisa M. Doherty, RN, NP, OCN 617-632-2166 Lisa_Doherty@dfci.harvard.edu | |
| Contact: Abigail Ciampa, NP 617-632-2166 Abigail_Ciampa@dfci.harvard.edu | |
| Principal Investigator: Patrick Y. Wen, MD | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Nancy Shearer, RN 617-726-7851 nshearer@partners.org | |
| Principal Investigator: Andrew Chi, MD | |
| United States, Virginia | |
| University of Virginia, Department of Neurology | Not yet recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: David Schiff, M.D. 434-982-4415 DS4JD@hscmail.mcc.virginia.edu | |
| Principal Investigator: David Schiff, M.D. | |
| Principal Investigator: | Patrick Y. Wen, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Dana-Farber Cancer Institute ( Patrick Wen, MD ) |
| Study ID Numbers: | 08-342, CLBH589BUS42T |
| Study First Received: | March 9, 2009 |
| Last Updated: | April 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00859222 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
LBH589 bevacizumab Avastin |
|
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Growth Inhibitors Glioma Angiogenesis Modulating Agents Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |