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

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, June 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
Novo Nordisk
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00500240
  Purpose

Primary Objective:

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, and/or longer survival.


Condition Intervention Phase
Leukemia
Lymphoma
Drug: Insulin Glargine
Drug: Insulin Aspart
Phase III

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma   

Drug Information available for:   Insulin    Insulin glargine    Insulin aspart    Dextrose   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To determine if aggressive management of hyperglycemia results in longer overall survival in patients with ALL, Burkitts lymphoma, or lymphoblastic lymphoma treated with HyperCVAD or variants of the HyperCVAD regimen. [ Time Frame: April 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:   114
Study Start Date:   April 2004
Estimated Study Completion Date:   April 2010
Estimated Primary Completion Date:   April 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1
Insulin Glargine
Drug: Insulin Glargine
Insulin Glargine
2
Insulin Aspart
Drug: Insulin Aspart
Insulin Aspart

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 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.

  Eligibility
Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Age >/= 15 years.
  2. Previously untreated ALL, Burkitt's lymphoma, or lymphoblastic leukemia receiving induction chemotherapy with hyper-CVAD or variants of the hyper-CVAD regimen.
  3. Random serum glucose >/= 180 mg/dL detected during the first 2 cycles of chemotherapy and confirmed with a second measurement.

Exclusion Criteria:

  1. History of Type I diabetes mellitus.
  2. Pregnancy or breast feeding.
  3. Allergy to insulin or insulin products.
  4. On-going treatment of steroid-induced hyperglycemia by an endocrinologist and/or general internist.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500240

Contacts
Contact: Khanh Vu, MD     713-745-0655    

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Khanh Vu, MD            

Sponsors and Collaborators
M.D. Anderson Cancer Center
Novo Nordisk

Investigators
Principal Investigator:     Khanh Vu, MD     U.T.M.D. Anderson Cancer Center    
  More Information


M.D. Anderson's Website  This link exits the ClinicalTrials.gov site
 

Responsible Party:   The University of Texas M. D. Anderson Cancer Center ( Khanh Vu, M.D./Assistant Professor )
Study ID Numbers:   2004-0107
First Received:   July 10, 2007
Last Updated:   June 5, 2008
ClinicalTrials.gov Identifier:   NCT00500240
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Acute Lymphocytic Leukemia  
Leukemia  
Lymphoma  
Burkitts Lymphoma  
Lymphoblastic Leukemia  
Blood Sugar
Hyperglycemia
Insulin Aspart
Insulin Glargine
Hyper-CVAD

Study placed in the following topic categories:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Insulin
Leukemia
Lymphatic Diseases
Burkitt's lymphoma
Hyperglycemia
Burkitt Lymphoma
Glargine
Insulin, Asp(B28)-
Hyperkinesis
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Hypoglycemic Agents
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 03, 2008




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