Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299156
Status:
COMPLETED
Last Update Posted:
2015-11-03
First Post:
2006-03-03
Brief Title:
Oral Clofarabine Study in Patients With Myelodysplastic Syndrome
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Oral Clofarabine in Myelodysplastic Syndrome MDS
Status:
COMPLETED
Status Verified Date:
2015-08
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 clofarabine given by mouth on a weekly schedule can help to control MDS The safety of clofarabine given by mouth will also be studied
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 you will be randomly assigned as in the roll of dice to one of 2 treatment groups Participants in Group 1 will take a lower dose of clofarabine than Participants in Group 2 You have an equal chance of being assigned to either of the 2 treatment groups Neither you nor your study doctor can choose your assignment Later after the first 40 patients the assignment will favor the better treatment arm until one arm is selected as the significantly better one or until 80 patients are treated in total When you have been assigned to a treatment group you will receive clofarabine as tablets once a day for 5 days in a row This will be repeated every 4-8 weeks Each 4-8 week period is considered 1 cycle of treatment
Original patients who are still on study original patients who received or are still receiving 30 mgm2 have already been reduced to lower doses on subsequent courses or had treatment discontinuedcompleted These patients will be asked to sign a new informed consent document to be made aware of the new developments in this study
Each dose of clofarabine should be taken with 4 ounces of water in the morning on an empty stomach You must not eat or drink anything besides water from midnight the night before you take the study drug until 1 hour after taking the morning dose You should take clofarabine every morning at about the same time If vomiting occurs within 15 minutes of taking clofarabine the dose may be repeated If vomiting occurs more than 15 minutes after taking clofarabine the dose cannot be replaced or made up
Coffee and other caffeinated liquids cannot be taken before dosing and for 1 hour after dosing
All clofarabine doses should be taken either in the outpatient or inpatient setting by qualified and trained site personnel or given with appropriate instructions to you andor your care provider to take at home At the start of each cycle you will receive enough clofarabine for 1 cycle of therapy You should store the clofarabine in its original container at room temperature You should keep the container closed when not in use and out of the reach of children
After each cycle of therapy you will not receive the next cycle of chemotherapy until your 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 given by vein is approved by the FDA for treatment of pediatric acute lymphoblastic leukemia Its use in this study is experimental Up to 80 patients will take part in this study All will be enrolled at MD Anderson
If you are found to be eligible you will be randomly assigned as in the roll of dice to one of 2 treatment groups Participants in Group 1 will take a lower dose of clofarabine than Participants in Group 2 You have an equal chance of being assigned to either of the 2 treatment groups Neither you nor your study doctor can choose your assignment Later after the first 40 patients the assignment will favor the better treatment arm until one arm is selected as the significantly better one or until 80 patients are treated in total When you have been assigned to a treatment group you will receive clofarabine as tablets once a day for 5 days in a row This will be repeated every 4-8 weeks Each 4-8 week period is considered 1 cycle of treatment
Original patients who are still on study original patients who received or are still receiving 30 mgm2 have already been reduced to lower doses on subsequent courses or had treatment discontinuedcompleted These patients will be asked to sign a new informed consent document to be made aware of the new developments in this study
Each dose of clofarabine should be taken with 4 ounces of water in the morning on an empty stomach You must not eat or drink anything besides water from midnight the night before you take the study drug until 1 hour after taking the morning dose You should take clofarabine every morning at about the same time If vomiting occurs within 15 minutes of taking clofarabine the dose may be repeated If vomiting occurs more than 15 minutes after taking clofarabine the dose cannot be replaced or made up
Coffee and other caffeinated liquids cannot be taken before dosing and for 1 hour after dosing
All clofarabine doses should be taken either in the outpatient or inpatient setting by qualified and trained site personnel or given with appropriate instructions to you andor your care provider to take at home At the start of each cycle you will receive enough clofarabine for 1 cycle of therapy You should store the clofarabine in its original container at room temperature You should keep the container closed when not in use and out of the reach of children
After each cycle of therapy you will not receive the next cycle of chemotherapy until your 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 given by vein is approved by the FDA for treatment of pediatric acute lymphoblastic leukemia Its use in this study is experimental Up to 80 patients will take part in this study All will be enrolled at MD 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