Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081887
Status:
TERMINATED
Last Update Posted:
2012-08-01
First Post:
2004-04-23
Brief Title:
Study of Weekly Clofarabine for the Treatment of RelapsedRefractory Chronic Lymphocytic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of Weekly Clofarabine for the Treatment of RelapsedRefractory Chronic Lymphocytic Leukemia
Status:
TERMINATED
Status Verified Date:
2012-07
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:
Primary Objectives
1 To determine the maximum tolerated dose MTD of clofarabine in Chronic Lymphocytic Leukemia CLL
2 To determine the toxicity profile of clofarabine in CLL
3 To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile of clofarabine in CLL
1 To determine the maximum tolerated dose MTD of clofarabine in Chronic Lymphocytic Leukemia CLL
2 To determine the toxicity profile of clofarabine in CLL
3 To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile of clofarabine in CLL
Detailed Description:
Clofarabine is a new chemotherapy drug that is designed to interfere with the growth and development of cancer cells
Before you can start treatment on the 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 complete medical history and physical examination You will also be asked about what medications you are taking currently and about the level of your daily activities Routine blood tests about 2 tablespoons will be done within 14 days before the start of the study to make sure that you are not at increased risk for developing side effects You may have bone marrow samples collected 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a bone marrow sample an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle
If you are found to be eligible you will receive clofarabine as a 1-hour infusion into a vein once once every 2 weeks for 4 weeks This cycle makes up one treatment course
The drug is evaluated at different dose levels The first three patients will start with a lower dose Unless serious side effects occur the next group of patients usually groups are 3 patients although they can be expanded to include more patients if needed will receive a higher dose
If you show a response and do not experience any severe side effects you can receive up to a total of 6 courses of therapy During each course clofarabine is given the same way as during the first course However the dose of clofarabine may be lowered during later courses to decrease the risk of side effects that may have occurred in previous courses 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
Before every treatment course your doctor will perform a physical exam including measurement of your weight and vital signs You will be asked about the level of your daily activities and how you are feeling At least once every two weeks more often if your doctor feels it is necessary you will have blood samples about 1-2 teaspoons collected for routine lab tests Repeat bone marrows will be collected after the third and sixth course However if you complete the study before the third course the bone marrow may be taken then No bone marrow may be taken if the condition of your disease is obvious from the blood
You will need to stay in Houston for the first 4 weeks of treatment After that you may return to your home but you will still have to return to Houston to receive the clofarabine treatment You may choose to have check-up visits and blood tests with your local doctor
After you finished your treatment and as long you are participating on this study you will be scheduled every 3-6 months to check on the status of the disease and your overall health
This is an investigational study Clofarabine is authorized by the FDA for use in research only Up to 36 participants will take part in this study All will be enrolled at M D Anderson
Before you can start treatment on the 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 complete medical history and physical examination You will also be asked about what medications you are taking currently and about the level of your daily activities Routine blood tests about 2 tablespoons will be done within 14 days before the start of the study to make sure that you are not at increased risk for developing side effects You may have bone marrow samples collected 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
If you are found to be eligible you will receive clofarabine as a 1-hour infusion into a vein once once every 2 weeks for 4 weeks This cycle makes up one treatment course
The drug is evaluated at different dose levels The first three patients will start with a lower dose Unless serious side effects occur the next group of patients usually groups are 3 patients although they can be expanded to include more patients if needed will receive a higher dose
If you show a response and do not experience any severe side effects you can receive up to a total of 6 courses of therapy During each course clofarabine is given the same way as during the first course However the dose of clofarabine may be lowered during later courses to decrease the risk of side effects that may have occurred in previous courses 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
Before every treatment course your doctor will perform a physical exam including measurement of your weight and vital signs You will be asked about the level of your daily activities and how you are feeling At least once every two weeks more often if your doctor feels it is necessary you will have blood samples about 1-2 teaspoons collected for routine lab tests Repeat bone marrows will be collected after the third and sixth course However if you complete the study before the third course the bone marrow may be taken then No bone marrow may be taken if the condition of your disease is obvious from the blood
You will need to stay in Houston for the first 4 weeks of treatment After that you may return to your home but you will still have to return to Houston to receive the clofarabine treatment You may choose to have check-up visits and blood tests with your local doctor
After you finished your treatment and as long you are participating on this study you will be scheduled every 3-6 months to check on the status of the disease and your overall health
This is an investigational study Clofarabine is authorized by the FDA for use in research only Up to 36 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