Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS) - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Eisai Inc.
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00067808

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 II

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:

MedlinePlus related topics: Cancer Leukemia Myelodysplastic Syndromes

Drug Information available for: 5-Aza-2'-deoxycytidine

U.S. FDA Resources

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:

M.D. Anderson Cancer Center's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Hagop Kantarjian, MD / Professor, UT MD 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:	June 3, 2011
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 February 12, 2012