Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500240
Status:
TERMINATED
Last Update Posted:
2015-06-03
First Post:
2007-07-10
Brief Title:
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia ALL
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated early due to futility
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 intense management and control of blood sugar levels during treatment for acute lymphocytic leukemia Burkitts lymphoma or lymphoblastic lymphoma will result in decreased risk of relapse fewer complications andor longer survival
Detailed Description:
High blood sugar is a common side effect of treatment for certain types of cancer
You will be randomly assigned as in the toss of a coin to one of two treatment groups Participants in one group will receive blood sugar management with regular human insulin Participants in the other group will receive more intense management with two newer forms of human insulin - insulin aspart for rapid lowering of the blood glucose and insulin glargine for the slow decrease of blood sugar level over 24 hours
You will receive additional blood tests about 1 tablespoon each at the time of entry on the study and after about every 2 to 4 courses of chemotherapy while on the study These blood tests help better define the severity of your high blood sugar and your bodys ability to metabolize sugar Any bone marrow and blood samples that were collected before your therapy for your leukemia may be used for lab tests to measure markers of glucose metabolism in the blood You will not be required to have a bone marrow biopsy after enrollment on study
While in the hospital receiving chemotherapy you will have your blood sugar checked 3 to 4 times a day To check your blood sugar level you your nurse or a laboratory technician will prick your finger with a small needle and place a small drop of blood on a test strip If your blood sugar is high you will be given the appropriate amount of insulin
Before you begin out-patient insulin treatment a research nurse doctor or diabetes educator will watch how you andor your caregiver administer your insulin shots to make sure that it is done correctly and safely Once you leave the hospital you will be required to check your own blood sugar 3 times a day and take insulin either yourself or with the help of a health provider up to 4 times a day while on steroid therapy and for 2 days after receiving steroids On all other days you will be required to check your blood glucose once or twice a day and administer insulin 1 - 3 times daily You will also need to speak with a nurse by phone every 1-3 days for review of blood sugar measurements and possible adjustment of the dose of insulin you must take
You will remain on the study from the time you are found to have high blood sugar levels until completion of your chemotherapy about 8 months for most patients You may be taken off this study at any time if you find that you are unable or unwilling to monitor your glucose or receive insulin shots at home
You will be followed for high blood sugar levels while you are receiving treatment with Hyper-CVAD chemotherapy regimen fractionated cyclophosphamide vincristine doxorubicin and dexamethasone alternating cycles with methotrexate cytarabine methylprednisolone If you continue to have high blood sugar after completion of this treatment you will have continued follow-up either with your primary physician at home or if you choose in the Internal Medicine Clinic at M D Anderson
This is an investigational study All of the insulin used in this study is FDA approved for the treatment of high blood sugar and commercially available A total of up to 114 patients will take part in this study All will be enrolled at M D Anderson
You will be randomly assigned as in the toss of a coin to one of two treatment groups Participants in one group will receive blood sugar management with regular human insulin Participants in the other group will receive more intense management with two newer forms of human insulin - insulin aspart for rapid lowering of the blood glucose and insulin glargine for the slow decrease of blood sugar level over 24 hours
You will receive additional blood tests about 1 tablespoon each at the time of entry on the study and after about every 2 to 4 courses of chemotherapy while on the study These blood tests help better define the severity of your high blood sugar and your bodys ability to metabolize sugar Any bone marrow and blood samples that were collected before your therapy for your leukemia may be used for lab tests to measure markers of glucose metabolism in the blood You will not be required to have a bone marrow biopsy after enrollment on study
While in the hospital receiving chemotherapy you will have your blood sugar checked 3 to 4 times a day To check your blood sugar level you your nurse or a laboratory technician will prick your finger with a small needle and place a small drop of blood on a test strip If your blood sugar is high you will be given the appropriate amount of insulin
Before you begin out-patient insulin treatment a research nurse doctor or diabetes educator will watch how you andor your caregiver administer your insulin shots to make sure that it is done correctly and safely Once you leave the hospital you will be required to check your own blood sugar 3 times a day and take insulin either yourself or with the help of a health provider up to 4 times a day while on steroid therapy and for 2 days after receiving steroids On all other days you will be required to check your blood glucose once or twice a day and administer insulin 1 - 3 times daily You will also need to speak with a nurse by phone every 1-3 days for review of blood sugar measurements and possible adjustment of the dose of insulin you must take
You will remain on the study from the time you are found to have high blood sugar levels until completion of your chemotherapy about 8 months for most patients You may be taken off this study at any time if you find that you are unable or unwilling to monitor your glucose or receive insulin shots at home
You will be followed for high blood sugar levels while you are receiving treatment with Hyper-CVAD chemotherapy regimen fractionated cyclophosphamide vincristine doxorubicin and dexamethasone alternating cycles with methotrexate cytarabine methylprednisolone If you continue to have high blood sugar after completion of this treatment you will have continued follow-up either with your primary physician at home or if you choose in the Internal Medicine Clinic at M D Anderson
This is an investigational study All of the insulin used in this study is FDA approved for the treatment of high blood sugar and commercially available A total of up to 114 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