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

Further Study Details: 

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

Criteria

PROTOCOL ENTRY 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

--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

Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21231-2410,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
Texas
      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   

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
ClinicalTrials.gov Identifier:  NCT00003361
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08