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Home > "D" Clinical Trials Conditions > Decitabine in Treating Patients With Myelodysplastic Syndrome  Decitabine in Treating Patients With Myelodysplastic Syndrome
Decitabine in Treating Patients With Myelodysplastic Syndrome
For Condition: de novo myelodysplastic syndrome,Refractory Anemia,secondary myelodysplastic syndrome,refractory anemia with excess blasts in transformation,refractory anemia with ringed sideroblasts,Chronic Myelomonocytic Leukemia,refractory anemia with excess blasts,Previously Treated Myelodysplastic Syndrome
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenNimer, Study Chair, Memorial Sloan-Kettering Cancer Center
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000066343; MSKCC-98017,NCI-G98-1444
Study Start Date: April 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003361
Other Secondary Myelodysplastic Syndrome Studies:
1. Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
2. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
3. Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia
4. Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome
5. Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome
Related Studies:
Other secondary myelodysplastic syndrome Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Decitabine in Treating Patients With Myelodysplastic Syndrome
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