Trial Information

Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia

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 body's 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 and/or 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. 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.