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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: | NCT00414310 |
The goal of this clinical research study is to find out if decitabine, given with or without valproic acid, can help to control AML or MDS. The safety of both treatments will also be studied.
Condition | Intervention | Phase |
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Myelodysplastic Syndrome Acute Myelogenous Leukemia |
Drug: Decitabine Drug: Valproic Acid |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Randomized Study of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) With or Without Valproic Acid in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia -"SPORE" |
Estimated Enrollment: | 150 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Decitabine
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Drug: Decitabine
Decitabine 20 mg/m2 IV over 1 hour daily X 5.
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2: Experimental
Decitabine + Valproic Acid
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Drug: Decitabine
Decitabine 20 mg/m2 IV over 1 hour daily X 5.
Drug: Valproic Acid
Valproic Acid 50 mg/kg orally daily X 7
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jean-Pierre Issa, MD | 713-745-2260 | jissa@mdanderson.org |
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Jean-Pierre Issa, MD 713-745-2260 jissa@mdanderson.org |
Principal Investigator: | Jean-Pierre Issa, MD | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Jean-Pierre Issa, M.D., Professor ) |
Study ID Numbers: | 2006-0686 |
Study First Received: | December 19, 2006 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00414310 |
Health Authority: | United States: Food and Drug Administration |
Decitabine Dacogen 5-AZA Valproic Acid |
Myelodysplastic Syndrome Acute Myelogenous Leukemia MDS AML |
Myelodysplastic syndromes Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Acute myelogenous leukemia Leukemia, Myeloid |
Decitabine Leukemia, Myeloid, Acute Valproic Acid Leukemia Preleukemia Bone Marrow Diseases Acute myelocytic leukemia |
Antimetabolites Neurotransmitter Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Enzyme Inhibitors Antimanic Agents Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Therapeutic Uses GABA Agents Central Nervous System Agents Anticonvulsants |