Spots Global Cancer Trial Database for Decitabine in Treating Patients With Myelodysplastic Syndrome
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Trial Identification
Brief Title: Decitabine in Treating Patients With Myelodysplastic Syndrome
Official Title: Phase II Study With Decitabine (5-aza-2'-Deoxycytidine, DAC) in Myelodysplastic Syndromes
Study ID: NCT00003361
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Stephen D. Nimer, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
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