Clinical Trial: Decitabine in Treating Patients With Myelodysplastic Syndrome

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)


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 Treatment or Intervention Phase
de novo myelodysplastic syndrome
refractory anemia with excess blasts in transformation
refractory anemia with excess blasts
Refractory Anemia
Previously Treated Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
secondary myelodysplastic syndrome
refractory anemia with ringed sideroblasts
 Drug: decitabine
Phase II

MedlinePlus related topics:  Anemia;   Bone Marrow Diseases;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Decitabine for Myelodysplastic Syndromes

Further Study Details: 

Study start: April 1998

OBJECTIVES: I. Determine the response of patients with myelodysplastic syndromes (including chronic myelomonocytic leukemia) to decitabine.

PROTOCOL 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.


Ages Eligible for Study:  15 Years and above



--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

--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

--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

Location Information

      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21231-2410,  United States

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066343; MSKCC-98017; NCI-G98-1444
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999 Identifier:  NCT00003361
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005