Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00067808
First received: August 27, 2003
Last updated: August 1, 2012
Last verified: August 2012
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Purpose
The goal of this clinical research study is to learn if decitabine (given at 3 different doses) can help to control Myelodysplastic Syndrome (MDS). The safety of these 3 treatments will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia |
Drug: Decitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Randomized Study of Three Different Schedules of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) in Myelodysplastic Syndrome (MDS) |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Participant Responses [ Time Frame: Response to treatment after 8 weeks of therapy ] [ Designated as safety issue: Yes ]Objective responses by International Working Group criteria: 'Complete Response' (CR) defined as Normalization of the peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 109/ L, and a platelet count > 100 x 109/L); 'Other Response' including Partial Remission (PR) defined as above, except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment combined with participants who meet all criteria for CR except for platelet recovery to >100 x 109/L; and 'No Response'.
| Enrollment: | 128 |
| Study Start Date: | October 2003 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Decitabine 10 mg/m^2 IV
10 mg/m^2 intravenous (IV) over 1 hour daily for 10 days
|
Drug: Decitabine
10 mg/m^2 by vein over 1 hour daily for 10 days
Other Name: Dacogen
|
|
Active Comparator: Decitabine 20 mg/m2 IV
20 mg/m2 IV over 1 hour daily for 5 days
|
Drug: Decitabine
20 mg/m2 by vein (IV) over 1 hour daily x 5 days
Other Name: Dacogen
|
|
Active Comparator: Decitabine 20 mg/m2 SQ
20 mg/m2 subcutaneous (SQ) daily for 5 days
|
Drug: Decitabine
20 mg/m2 subcutaneous (SQ) daily x 5 days
Other Name: Dacogen
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- MDS and 5% or more marrow blasts, or IPSS risk intermediate 1-2 or high risk; or chronic myelomonocytic leukemia
- Performance status 0-2 (Eastern Cooperative Oncology Group (ECOG) scale); adequate hepatic (bilirubin < 2 mg/dl) and renal functions (creatinine <2mg/dl); New York Heart Association (NYHA) cardiac status III-IV excluded.
- Signed informed consent
- No prior intensive combination chemotherapy or high-dose ara-C (>/= 1g/m2 per dose). Prior biologic therapies, targeted therapies and single agent chemotherapy allowed.
- Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. Use of Hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy.
Exclusion Criteria:
- Nursing and pregnant females are excluded. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Patients with active and uncontrolled infections
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067808
Locations
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eisai Inc.
Investigators
| Principal Investigator: | Hagop M Kantarjian, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00067808 History of Changes |
| Other Study ID Numbers: | ID03-0180 |
| Study First Received: | August 27, 2003 |
| Results First Received: | September 25, 2009 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia MDS |
Decitabine Dacogen Methylation |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Preleukemia Leukemia, Myelomonocytic, Acute Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Hematologic Diseases |
Precancerous Conditions Decitabine Azacitidine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013