Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422032
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2007-01-11
Brief Title:
2 Arm Study of Clofarabine IV in MDS Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Randomized Study of Two Different Schedules of Intravenous Clofarabine in Myelodysplastic Syndrome MDS
Status:
COMPLETED
Status Verified Date:
2012-06
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 compare the effectiveness of 2 different doses of the drug clofarabine that can be given on a weekly schedule for the treatment of Myelodysplastic Syndrome MDS The safety of these two doses will also be compared
Primary Objective Compare the response rates of two dose schedules of clofarabine in MDS
Secondary Objective Compare response durations survivals and side effects of the two schedules
Primary Objective Compare the response rates of two dose schedules of clofarabine in MDS
Secondary Objective Compare response durations survivals and side effects of the two schedules
Detailed Description:
Clofarabine is a new chemotherapy drug that is designed to interfere with the growth and development of cancer cells
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of a coin to one of two treatment groups Groups A and B Participants in Group A will receive a lower dose of clofarabine Participants in Group B will receive a higher dose of clofarabine At first there will be an equal chance of being assigned to either group However as experience increases and more information becomes available the chance of being assigned to the group that has shown the most effectiveness will increase You and the study doctor will know to which group you are assigned
Participants will receive clofarabine as a 1-hour infusion into a vein once a day for 5 days in a row This will be repeated every 4 to 8 weeks Each 4-8 week period is considered 1 cycle of treatment
For participants in both groups after each cycle of therapy they will not receive the next cycle of chemotherapy until their blood counts have recovered and any possible side effects have gone away for around 4 to 8 weeks You must stay in Houston for the first treatment cycle about 4 to 8 weeks and will be required to return to Houston before receiving each additional cycle of chemotherapy up to 6 days each cycle
Before every treatment cycle your doctor will perform a physical exam including measurement of your weight and vital signs blood pressure heart rate temperature and breathing rate You will be asked about the level of your daily activities and how you are feeling You will have blood samples about 1-2 teaspoons collected for routine lab tests 1-2 times a week for the first cycle then every 2-4 weeks while on therapy Repeat bone marrow samples will be collected every 1-3 cycles However if you complete the study before the third cycle the bone marrow may be taken then You may choose to have check-up visits and blood tests with your local doctor
If you show a response and do not experience any severe side effects you can receive up to a total of 12 cycles of therapy During each cycle clofarabine will be given the same way as during the first cycle However the dose of clofarabine may be lowered during later cycles to decrease the risk of side effects that may have occurred in previous cycles If the disease gets worse or you experience any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
This is an investigational study Clofarabine is approved by the FDA for treatment of pediatric acute lymphoblastic leukemia Its use in this study is experimental Up to 60 participants will take part in this study All will be enrolled at M D Anderson
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of a coin to one of two treatment groups Groups A and B Participants in Group A will receive a lower dose of clofarabine Participants in Group B will receive a higher dose of clofarabine At first there will be an equal chance of being assigned to either group However as experience increases and more information becomes available the chance of being assigned to the group that has shown the most effectiveness will increase You and the study doctor will know to which group you are assigned
Participants will receive clofarabine as a 1-hour infusion into a vein once a day for 5 days in a row This will be repeated every 4 to 8 weeks Each 4-8 week period is considered 1 cycle of treatment
For participants in both groups after each cycle of therapy they will not receive the next cycle of chemotherapy until their blood counts have recovered and any possible side effects have gone away for around 4 to 8 weeks You must stay in Houston for the first treatment cycle about 4 to 8 weeks and will be required to return to Houston before receiving each additional cycle of chemotherapy up to 6 days each cycle
Before every treatment cycle your doctor will perform a physical exam including measurement of your weight and vital signs blood pressure heart rate temperature and breathing rate You will be asked about the level of your daily activities and how you are feeling You will have blood samples about 1-2 teaspoons collected for routine lab tests 1-2 times a week for the first cycle then every 2-4 weeks while on therapy Repeat bone marrow samples will be collected every 1-3 cycles However if you complete the study before the third cycle the bone marrow may be taken then You may choose to have check-up visits and blood tests with your local doctor
If you show a response and do not experience any severe side effects you can receive up to a total of 12 cycles of therapy During each cycle clofarabine will be given the same way as during the first cycle However the dose of clofarabine may be lowered during later cycles to decrease the risk of side effects that may have occurred in previous cycles If the disease gets worse or you experience any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
This is an investigational study Clofarabine is approved by the FDA for treatment of pediatric acute lymphoblastic leukemia Its use in this study is experimental Up to 60 participants 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