Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113321
Status:
TERMINATED
Last Update Posted:
2012-08-07
First Post:
2005-06-07
Brief Title:
Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Low-Dose Decitabine 5-AZA-2-Deoxycytidine in Myelodysplastic Syndrome MDS Post Azacytidine AZA Failure
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study if decitabine can help to control Myelodysplastic Syndrome MDS in patients who have failed on therapy with azacytidine the current standard of therapy
Detailed Description:
Methylation is a change that occurs to Deoxyribonucleic acid 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a bone marrow aspirate an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle Women who are able to have children must have a negative blood or urine pregnancy test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 Food and Drug Administration FDAapproved 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
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 Food and Drug Administration FDAapproved 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None