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Phase II Study With Decitabine (5-aza-2'-Deoxycytidine, DAC) in Myelodysplastic Syndromes
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of decitabine in treating patients with myelodysplastic syndrome.
OBJECTIVES: I. Determine the response of patients with myelodysplastic syndromes (including chronic myelomonocytic leukemia) to decitabine. OUTLINE: This is an open label, multicenter study. Patients are stratified by disease (low risk myelodysplastic syndrome (MDS) vs. high risk MDS vs. chronic myelomonocytic leukemia). Patients receive decitabine as a 4 hour infusion every 8 hours on days 1-3. Treatment continues every 6-8 weeks for 4-6 courses. Patients are followed at 6 and 12 months. PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study over 1 year.
Age
15 - No limit years
Sex
ALL
Healthy Volunteers
No
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Start Date
April 1, 1998
Primary Completion Date
September 1, 2003
Completion Date
December 1, 2009
Last Updated
June 26, 2013
75
ESTIMATED participants
decitabine
DRUG
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07388563