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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Eisai Medical Research Inc. |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00075010 |
Valproic acid is a medication that is currently used in the prevention of seizures, bipolar disorder, and migraine headaches. Researchers hope that it may improve the effects of decitabine. Decitabine is a chemotherapy drug with known activity in leukemia and myelodysplastic syndromes.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Drug: Decitabine Drug: Valproic acid |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of 5-Aza-2'-Deoxycytidine and Valproic Acid in Patients With Relapsed/Refractory Leukemia or Myelodysplastic Syndromes |
Enrollment: | 54 |
Study Start Date: | January 2004 |
Study Completion Date: | November 2006 |
Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Decitabine + Valproic acid
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Drug: Decitabine
15mg/m2 IV over 1 hour times 10 days
Drug: Valproic acid
20mg/kg daily times 10 days
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Recent studies have shown synergy between demethylating agents and histone deacetylase inhibitors. It has been shown that both DNA methylation and histone deacetylation work together in affecting gene expression.
Therefore, drugs that inhibit DNA methylation and those that inhibit histone deacetylase can reactivate silenced genes in combination better than they can individually. Decitabine (5 aza-2'deoxycytidine), a drug that produces marked DNA hypomethylator, has demonstrated antileukemic activity at low doses. There are several drugs that have been shown to have histone acetylase activity. One of these is valproic acid that has been used safely for many years as an anti-seizure medication.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION FOR PHASE I COMPONENT OF THE STUDY:
INCLUSION OF PHASE II PORTION OF THE STUDY:
Exclusions
United States, Texas | |
M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Guillermo Garcia-Manero, M.D. | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M.D. Anderson Cancer Center ( Guillermo Garcia-Manero M.D./Associate Professor ) |
Study ID Numbers: | 2003-0314 |
Study First Received: | December 29, 2003 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00075010 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Relapsed/Refractory Leukemia Myelodysplastic Syndromes |
Antimetabolites Neurotransmitter Agents Tranquilizing Agents Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Psychotropic Drugs Central Nervous System Depressants |
Decitabine Antimanic Agents Valproic Acid Leukemia Preleukemia Bone Marrow Diseases Anticonvulsants |
Antimetabolites Neurotransmitter Agents Antimetabolites, Antineoplastic Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Psychotropic Drugs Valproic Acid Leukemia Preleukemia Pathologic Processes Syndrome Therapeutic Uses Disease |
Neoplasms by Histologic Type Tranquilizing Agents Hematologic Diseases Myelodysplastic Syndromes Central Nervous System Depressants Enzyme Inhibitors Decitabine Antimanic Agents Pharmacologic Actions Neoplasms GABA Agents Bone Marrow Diseases Central Nervous System Agents Anticonvulsants |