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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00691938 |
This study is designed to evaluate the combination of LBH589 and decitabine in patients age ≥ 60 years with high risk Myelodysplastic Syndrome (IPSS Int-2 or High) or Acute Myeloid Leukemia.
Condition | Intervention | Phase |
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Leukemia, Myeloid, Acute Myelodysplastic Syndromes |
Drug: LBH589 Drug: Decitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of LBH589 Plus Decitabine for Patients Age ≥ 60 Years With High Risk MDS or AML |
Estimated Enrollment: | 66 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: LBH589
20mg/m2/day IV day 1 thru 5
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To address the need for less toxic, more effective treatments for older patients with advanced MDS and AML, the purpose of this Phase 1-2 single institution study is to evaluate the safety and efficacy of LBH 589 and decitabine administered in combination.
Decitabine is an epigenetic modifier of gene expression that has been shown to be well-tolerated in this population at the dose schedule proposed in this study, with reasonable efficacy. Although its precise mechanism of action is incompletely understood, it is postulated to work by reactivating the expression of key tumor suppressor genes silenced in tumor cells by reversing a pattern of hypermethylation of promotor elements.
LBH389 is likewise an epigenetic modifier that inhibits the deacetylation of both histones and non-histone proteins, including HSP90 and p53. Although clinical experience with LBH589 in AML is limited, aberrant histone deacetylase activity has been previously shown to play a significant role in the pathogenesis of AML. The addition of LBH589 to a decitabine regimen of previously established efficacy and tolerability will allow us to evaluate the hypothesis that two epigenetic modifiers that are believed to work through distinct mechanisms of action may act together to improve the responses of patients treated with decitabine alone, without significant additional toxicity.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Geoffrey Uy, M.D. | 314-454-8304 | guy@wustl.edu |
United States, Missouri | |
Washington University | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Geoffrey Uy, M.D. 314-454-8304 guy@wustl.edu | |
Principal Investigator: Geoffrey Uy, M.D. | |
Sub-Investigator: Peter Westervelt, M.D., Ph.D. | |
Sub-Investigator: Camille Abboud, M.D. | |
Sub-Investigator: Amanda Cashen, M.D. | |
Sub-Investigator: John DiPersio, M.D., Ph.D. | |
Sub-Investigator: Timothy Graubert, M.D. | |
Sub-Investigator: Keith Stockerl-Goldstein, M.D. | |
Sub-Investigator: Michael Tomasson, M.D. | |
Sub-Investigator: Ravi Vij, M.D. | |
Sub-Investigator: Matthew Walter, M.D. | |
Sub-Investigator: Stephanie Bauer, RN, MSN, FNP | |
Sub-Investigator: George Bryant, ND, APRN | |
Sub-Investigator: Holly Comer, RN, FNP | |
Sub-Investigator: Edie Romvari, RN, MSN, FNP | |
Sub-Investigator: Eric Ruettgers, RN, FNP |
Principal Investigator: | Geoffrey Uy, M.D. | Washington Univerisity |
Responsible Party: | Washington University ( Geoffrey Uy, M.D. ) |
Study ID Numbers: | 08-0172 |
Study First Received: | June 4, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00691938 |
Health Authority: | United States: Food and Drug Administration |
LBH589 Decitabine panobinostat |
histone deacetylase methylation hypomethylation |
Myelodysplastic syndromes Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Acute myelogenous leukemia Leukemia, Myeloid |
Decitabine Leukemia, Myeloid, Acute Leukemia Preleukemia Bone Marrow Diseases Acute myelocytic leukemia |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Pathologic Processes Disease Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Syndrome Enzyme Inhibitors Pharmacologic Actions |