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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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 Study Completion Date: | December 2012 |
| 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):
• Patients may have been treated for any number of prior relapses. Relapse is defined as progression following initial therapy
PHASE II Inclusion Criteria (phase II patients must meet the general eligibility criteria as well as the following):
Exclusion Criteria:
Subject has received previous therapy with anti-VEGF targeted agents or with any histone deacetylase inhibitors. (Prior treatment with valproic acid for seizures is allowed but requires a washout of at least 14 days prior to starting LBH589.) Although concomitant use of the following drugs is not allowed on study, previous use is allowed, provided patients meet the following mandatory washout periods:
i. Drugs w/ risk of causing TdP = 72 hrs; ii. Warfarin = 7 days.
Contacts and Locations| Contact: Patrick Y. Wen, MD | 617-632-2166 | pwen@partners.org |
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Katie McCarthy 312-695-1301 katie-mccarthy@northwestern.edu | |
| 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: Beverly Spicer, RN 617-726-7851 bspicer@partners.org | |
| Principal Investigator: Andrew Chi, MD | |
| United States, Virginia | |
| University of Virginia, Department of Neurology | 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: | Patrick Wen, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00859222 History of Changes |
| Other Study ID Numbers: | 08-342, CLBH589BUS42T |
| Study First Received: | March 9, 2009 |
| Last Updated: | July 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
LBH589 bevacizumab Avastin |
|
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Bevacizumab |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |