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)

Tracking Information

First Submitted Date ^ICMJE

November 1, 1999

First Posted Date ^ICMJE

March 12, 2004

Last Update Posted Date

June 26, 2013

Study Start Date ^ICMJE

April 1998

Actual Primary Completion Date

September 2003 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Decitabine in Treating Patients With Myelodysplastic Syndrome

Official Title ^ICMJE

Phase II Study With Decitabine (5-aza-2'-Deoxycytidine, DAC) in Myelodysplastic Syndromes

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Leukemia
Myelodysplastic Syndromes

Intervention ^ICMJE

Drug: decitabine

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date ^ICMJE

December 2009

Actual Primary Completion Date

September 2003 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

15 Years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00003361

Other Study ID Numbers ^ICMJE

MSKCC-98017
CDR0000066343 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-G98-1444

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Memorial Sloan Kettering Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Stephen D. Nimer, MD

Memorial Sloan Kettering Cancer Center

PRS Account

National Cancer Institute (NCI)

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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