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Decitabine (DAC) w/ or w/o Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, November 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
Eisai Medical Research Inc.
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00414310
  Purpose

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
Myelodysplastic Syndrome
Acute Myelogenous Leukemia
Drug: Decitabine
Drug: Valproic Acid
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid 5-Aza-2'-deoxycytidine Deoxycytidine
U.S. FDA Resources
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"

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Compare the response rates to decitabine with or without valproic acid in MDS and AML. [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare response durations, survivals and side effects of the two regimens. Compare epigenetic modulation (gene expression, hypomethylation, histone acetylation) between the two regimens. [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

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
1: Experimental
Decitabine
Drug: Decitabine
Decitabine 20 mg/m2 IV over 1 hour daily X 5.
2: Experimental
Decitabine + Valproic Acid
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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with MDS and > 5% blasts or IPSS risk intermediate or high; patients with CMML; patients with AML who are age 60 or older. No prior intensive chemotherapy or high-dose ara-C (> 1g/m2). No prior azacytidine for 3 cycles or more or prior decitabine for 2 cycles or more. Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed. Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
  • Continued from #1: Hydroxyurea is permitted for control of counts prior to treatment. Procrit, GCSF are allowed before therapy. Procrit, GCSF or other growth factors are permitted on therapy. Use of hydroxyurea with rapidly proliferative disease is allowed for the first two weeks on therapy.
  • Performance 0-2 (ECOG). Adequate liver function (bilirubin of < 2mg/dl) and renal function (creatinine < 2mg/dl). Adequate cardiac functions (NYHA cardiac III-IV excluded). ALT < 2.5x institutional upper limit of normal.
  • Signed informed consent.

Exclusion Criteria:

  • Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Active and uncontrolled infections.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Known ornithine transcarbamylase disorder.
  • Patients requiring continuous valproic acid treatment for the control of seizure disorders.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414310

Contacts
Contact: Jean-Pierre Issa, MD 713-745-2260 jissa@mdanderson.org

Locations
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    
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eisai Medical Research Inc.
Investigators
Principal Investigator: Jean-Pierre Issa, MD M.D. Anderson Cancer Center
  More Information

(M.D. Anderson's website)  This link exits the ClinicalTrials.gov site

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

Keywords provided by M.D. Anderson Cancer Center:
Decitabine
Dacogen
5-AZA
Valproic Acid
Myelodysplastic Syndrome
Acute Myelogenous Leukemia
MDS
AML

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009