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Home > "D" Clinical Trials Conditions > Decitabine Compared With Supportive Care in Treating Patients With Advanced Myelodysplastic Syndromes  Decitabine Compared With Supportive Care in Treating Patients With Advanced Myelodysplastic Syndromes
Decitabine Compared With Supportive Care in Treating Patients With Advanced Myelodysplastic Syndromes
For Condition: refractory anemia with excess blasts in transformation,Chronic Myelomonocytic Leukemia,Refractory Anemia,previously treated myelodysplastic syndromes,refractory anemia with ringed sideroblasts,refractory anemia with excess blasts,secondary myelodysplastic syndromes,de novo myelodysplastic syndromes
Status: No longer recruiting
Sponsor(s): SuperGen ,
Synopsis: RATIONALE: The use of decitabine may delay disease progression in patients who have advanced myelodysplastic syndromes. It is not yet known whether decitabine is more effective than supportive care in delaying disease progression. PURPOSE: Randomized phase III trial to compare the effectiveness of decitabine with that of supportive care in treating patients who have advanced myelodysplastic syndromes.
Details: OBJECTIVES: - Determine the safety and efficacy of decitabine in patients with advanced myelodysplastic syndromes. - Compare the time to acute myeloid leukemia progression (at least 30% blasts) or death of patients treated with decitabine vs supportive care. - Compare the overall hematologic response rate and duration of response of patients treated with these regimens. - Compare the survival of patients treated with these regimens. - Determine the toxicity of decitabine in these patients. - Compare the transfusion requirements and incidence of febrile neutropenic episodes of patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to International Prognostic Scoring System risk group (intermediate vs high-risk myelodysplastic syndromes [MDS]), prior treatment (beyond supportive care) for MDS (yes vs no), type of MDS (secondary vs de novo), and participating center. Patients are randomized to one of two treatment arms. - Arm I: Patients receive decitabine IV over 3 hours, every 8 hours on days 1-3. Treatment repeats approximately every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, hematologic improvement, or partial response (PR) may receive a total of 6 courses of therapy. Patients achieving a PR or complete response after 6 courses of therapy may receive an additional 4 courses. - Arm II: Patients receive supportive care. Patients who progress on supportive care may cross over and receive decitabine as in arm I. Quality of life is assessed at baseline, every 6 weeks, and then at 8-10 weeks after study. Patients are followed at 8-10 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 160 patients (80 per arm) will be accrued for this study within 6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of advanced de novo or secondary myelodysplastic syndromes (MDS) with WBC less than 12,000/mm - and International Prognostic Scoring System score at least 0.5 - Refractory anemia (RA) - RA with ringed sideroblasts - RA with excess blasts (RAEB) - RAEB in transformation - Chronic myelomonocytic leukemia - No acute myeloid leukemia (30% or more bone marrow blasts) or other progressive malignant disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - No superimposed autoimmune hemolytic anemia - No superimposed immune-based thrombocytopenia Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGPT no greater than 2 times upper limit of normal Renal: - Creatinine no greater than 2 mg/dL Cardiovascular: - No uncontrolled cardiac disease - No congestive heart failure Pulmonary: - Oxygen saturation at least 90% on room air - No uncontrolled restrictive or obstructive pulmonary disease Other: - No mental illness or other condition that would preclude study compliance - No other active malignancy within the past 3 years (2 years for basal or squamous cell skin cancer or carcinoma in situ of the cervix) - No active untreated viral or bacterial infection - Afebrile for past 7 days without antibiotics - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for 30 days before, during, and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent epoetin alfa or thrombopoietin Chemotherapy: - Prior chemotherapy for treatment of a malignancy allowed Endocrine therapy: - At least 14 days since prior androgenic hormones - At least 14 days since prior danazol - Concurrent topical or inhaled corticosteroids allowed - No concurrent systemic steroids except as prophylaxis for transfusion reactions (e.g., hydrocortisone IV) - No concurrent danazol Radiotherapy: - Prior radiotherapy for treatment of a malignancy allowed Surgery: - Not specified Other: - At least 2 weeks since other prior agents for MDS - At least 30 days since prior investigational agents - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnLyons, Study Chair, SuperGen
Loma Linda University Cancer Institute
Loma Linda, California, 92354
United States
Scripps Clinic
La Jolla, California, 92037
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, 33612
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
Tuft-New England Medical Center
Boston, Massachusetts, 02111-1854
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0296
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
United States
Southwest Regional Cancer Center
Austin, Texas, 78705
United States
Siteman Cancer Center
St. Louis, Missouri, 63110
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Texas Oncology P.A.
Dallas, Texas, 75230-2503
United States
Memphis Cancer Center
Memphis, Tennessee, 38119
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Rush Cancer Institute
Chicago, Illinois, 60612
United States
Additional Information:
Study ID Numbers: CDR0000068779; SUPERGEN-D-0007,ABCCC-010303
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022061
Other Refractory Anemia With Excess Blasts In Transformation Studies:
1. VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies
2. Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia
3. Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome
4. Liposomal Daunorubicin and SU5416 in Treating Patients With Hematologic Cancer That Has Not Responded to Initial Therapy
5. Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
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Decitabine Compared With Supportive Care in Treating Patients With Advanced Myelodysplastic Syndromes
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