Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067808
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2003-08-27
Brief Title:
Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome MDS
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Randomized Study of Three Different Schedules of Low-Dose Decitabine 5-AZA-2-Deoxycytidine in Myelodysplastic Syndrome MDS
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Treatment Methylation is a change that occurs to Deoxyribonucleic acid DNA that has an effect on gene usage in human cells Abnormal methylation is very common in leukemias Decitabine is a new drug that blocks DNA methylation
Before treatment starts a physical exam blood tests between 4-6 tablespoons and a bone marrow study will be done To collect a bone marrow sample an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle Women able to have children must have a negative blood or urine pregnancy test
When this study began participants were randomly assigned as in the toss of a coin to one of 3 treatment groups The assignment to one of the 3 schedules was adjusted according to how well patients respond to treatment About 17 patients were assigned to each group for the first 50 patients
Participants in the first group received decitabine intravenously IV--through a needle in their vein over one hour once a day for 10 days Treatment was given every 4 to 8 weeks depending on how well their blood counts recovered Participants in the second group received decitabine as an IV infusion over one hour once a day for 5 days Treatment was given every 4 to 8 weeks Participants who received decitabine by vein got the same total dose per course Participants in the third group received decitabine by subcutaneous SQ injections injections given under the skin twice a day for 5 days As in the first and second group treatment was given every 4 to 8 weeks
After 65 patients were enrolled on this study it was decided that the 5-day IV schedule was the best of the 3 schedules The study will now continue with all new patients receiving the 5 -day IV decitabine treatment If you are now enrolling on the study you will be placed in this treatment group instead of being randomly assigned to a treatment group
Participants who are already on study and who are receiving the 5-day SQ schedule or the 10-day IV schedule will be given the option to change to the 5-day IV schedule at the start of their next course of study drug treatment since this is considered the new standard schedule on this particular study
If you choose to take part in this study and begin receiving the study treatment described above your response to treatment will be checked after completing 8 weeks of therapy If the response to treatment is good treatment with decitabine will continue Decitabine treatment may be continued for up to 24 courses or as long as it is judged best to control the leukemia
During this study you will need to visit your doctor for a physical exam and 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 Periodic bone marrow samples will also be taken to check cells related to the disease before during and after completion of this study
Patients 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 FDA approvedUp to 133 participants will be treated in this study All will be enrolled at M D Anderson
Before treatment starts a physical exam blood tests between 4-6 tablespoons and a bone marrow study will be done To collect a bone marrow sample 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 able to have children must have a negative blood or urine pregnancy test
When this study began participants were randomly assigned as in the toss of a coin to one of 3 treatment groups The assignment to one of the 3 schedules was adjusted according to how well patients respond to treatment About 17 patients were assigned to each group for the first 50 patients
Participants in the first group received decitabine intravenously IV--through a needle in their vein over one hour once a day for 10 days Treatment was given every 4 to 8 weeks depending on how well their blood counts recovered Participants in the second group received decitabine as an IV infusion over one hour once a day for 5 days Treatment was given every 4 to 8 weeks Participants who received decitabine by vein got the same total dose per course Participants in the third group received decitabine by subcutaneous SQ injections injections given under the skin twice a day for 5 days As in the first and second group treatment was given every 4 to 8 weeks
After 65 patients were enrolled on this study it was decided that the 5-day IV schedule was the best of the 3 schedules The study will now continue with all new patients receiving the 5 -day IV decitabine treatment If you are now enrolling on the study you will be placed in this treatment group instead of being randomly assigned to a treatment group
Participants who are already on study and who are receiving the 5-day SQ schedule or the 10-day IV schedule will be given the option to change to the 5-day IV schedule at the start of their next course of study drug treatment since this is considered the new standard schedule on this particular study
If you choose to take part in this study and begin receiving the study treatment described above your response to treatment will be checked after completing 8 weeks of therapy If the response to treatment is good treatment with decitabine will continue Decitabine treatment may be continued for up to 24 courses or as long as it is judged best to control the leukemia
During this study you will need to visit your doctor for a physical exam and 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 Periodic bone marrow samples will also be taken to check cells related to the disease before during and after completion of this study
Patients 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 FDA approvedUp to 133 participants will be treated 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