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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Eisai Medical Research Inc. |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00113321 |
Purpose
To study if decitabine can help to control MDS in patients who have failed on therapy with azacytidine, the current standard of therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia |
Drug: Decitabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
| Official Title: | Phase II Study of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) in Myelodysplastic Syndrome (MDS) Post Azacytidine (AZA) Failure |
| Enrollment: | 16 |
| Study Start Date: | March 2005 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Decitabine: Experimental |
Drug: Decitabine
20 mg/m2 IV over 1 hour daily x 5 days. If necessary alternative to IV is decitabine 10 mg/m^2 subcutaneous twice a day x 5 days (20 mg/m^2 daily).
|
Methylation is a change that occurs to DNA that affects gene usage in human cells. Abnormal methylation is very common in leukemias, which is a related disease to MDS. Decitabine is a new drug that blocks DNA methylation.
Researchers want to find out if blocking methylation will help control MDS.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a physical exam, routine blood tests (between 4-6 tablespoons), and a bone marrow aspirate. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found to be eligible to take part in this study, you will receive decitabine by vein over one hour, once a day, for 5 days (1 course). If this is not possible due to complications, you will receive the drug as an injection under the skin twice a day for 5 days (1 course). Treatment will be given every 4 to 8 weeks depending on how well your blood counts recover.
After completing 8-12 weeks of therapy, response will be evaluated. If the response to treatment is good, treatment with decitabine will continue. Decitabine treatment may be continued for up to 12 courses, or as long as it is judged best to control the leukemia.
During this study, you will need to visit your doctor periodically for physical exams and measurement of vital signs. The frequency of doctor visits will vary depending on your physical condition, but will be required at least once a month.
Blood tests (about 2 teaspoons) will be done about every week during the first 6-8 weeks of treatment, then every 1 to 2 weeks for the length of the study. The blood samples will be used for routine lab tests. Every 1-3 courses, bone marrow samples will also be taken to check cells related to the disease before, during (every 1-3 courses), and after completion of this study.
You will be taken off study if the disease gets worse or intolerable side effects occur.
This is an investigational study. Decitabine is not yet FDA approved. It will be provided free of charge by MGI Pharma. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Hagop Kantarjian, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | The University of M.D. Anderson Cancer Center ( Hagop Kantarjian, M.D., Professor ) |
| Study ID Numbers: | 2004-0468 |
| Study First Received: | June 7, 2005 |
| Last Updated: | August 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00113321 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia Azacytidine Failure Decitabine |
|
Antimetabolites Chronic Myelomonocytic Leukemia Precancerous Conditions Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myeloproliferative Disorders Decitabine |
Leukemia, Myeloid Leukemia, Myelomonocytic, Acute Leukemia Preleukemia Azacitidine Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Myelodysplastic Myeloproliferative Disease |
|
Antimetabolites Antimetabolites, Antineoplastic Disease Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Enzyme Inhibitors Decitabine |
Leukemia, Myeloid Pharmacologic Actions Leukemia, Myelomonocytic, Acute Leukemia Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Azacitidine Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases |
