Decitabine in Treating Patients With Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT00003361

Recruitment Status : Completed

First Posted : March 12, 2004

Last Update Posted : June 26, 2013

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

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.

Condition or disease	Intervention/treatment	Phase
Leukemia Myelodysplastic Syndromes	Drug: decitabine	Phase 2

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	75 participants
Primary Purpose:	Treatment
Official Title:	Phase II Study With Decitabine (5-aza-2'-Deoxycytidine, DAC) in Myelodysplastic Syndromes
Study Start Date :	April 1998
Actual Primary Completion Date :	September 2003
Actual Study Completion Date :	December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Myelodysplastic Syndromes

Drug Information available for: Decitabine

Genetic and Rare Diseases Information Center resources: Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Myelodysplastic Syndrome With Excess Blasts Sideroblastic Anemia Pyridoxine-refractory Autosomal Recessive

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	15 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS: Histologically proven myelodysplastic syndrome Refractory anemia (RA) RA with ringed sideroblasts (RARS) RA with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia (CMML) RA and RARS: Platelet count less than 50,000/mm3 CMML: If WBC greater than 10,000/mm3, then must have at least 8% monocytes in the blood or marrow

PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active or uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception No other active cancer except skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than one prior chemotherapy regimen for myelodysplastic syndromes At least 3 weeks since chemotherapy and recovered No prior high-dose cytarabine (at least 0.5 g/m2 for at least 4 doses) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003361

Locations


United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231-2410
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

National Cancer Institute (NCI)

Investigators


Study Chair:	Stephen D. Nimer, MD	Memorial Sloan Kettering Cancer Center

More Information


ClinicalTrials.gov Identifier:	NCT00003361 History of Changes
Other Study ID Numbers:	MSKCC-98017 CDR0000066343 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-G98-1444
First Posted:	March 12, 2004 Key Record Dates
Last Update Posted:	June 26, 2013
Last Verified:	December 2009

Keywords provided by National Cancer Institute (NCI):


refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia	de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes childhood myelodysplastic syndromes

Additional relevant MeSH terms:


Syndrome Myelodysplastic Syndromes Preleukemia Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions	Neoplasms Decitabine Azacitidine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors

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