OSU 0479: Flavopiridol in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia
What is the purpose of this study?
The goals of this research study are:
- To determine the highest safe dose of an experimental medicine, Flavopiridol, in the treatment of acute leukemias
- To learn what kind of side effects Flavopiridol can cause
- To learn more about the pharmacology (how the body handles the drug) of Flavopiridol
- To slow or stop the growth of leukemia or, if possible, reduce the activity of leukemia
- To gain information about leukemia and how it is affected by Flavopiridol
Who will be included in this study?
Patients with acute leukemias who are 1 to 17 years old are eligible to participate in this clinical trial.
What is involved?
Flavopiridol will be given by intravenous (IV) infusion through a central line for 3 days every month. For at least the first two cycles of treatment, the drug will be given in the ICU. Patients who do not have serious side effects, and whose leukemia is not getting worse, may continue to get Flavopiridol for up to 6 treatment cycles.
Before patients can participate in this study, they will take part in a screening process that will include:
- Medical history
- Physical examination
- Blood tests to test how well your bone marrow, liver, kidneys, and thyroid are functioning
- Pregnancy test (if you are a woman who could have children)
- Bone marrow biopsy and aspirate (a procedure in which an area of the hip is numbed with a drug so you cannot feel the area and a small sample of bone and bone marrow are removed through a needle)
- Electrocardiogram (EKG) to make a tracing of how your heart beats
- Echocardiogram (ECHO) or a nuclear medicine scan called a MUGA scan to check the strength of your heart
- Radiology tests such as chest x-ray (if necessary)
The following tests are all necessary to make sure that patients are not having unsafe side effects of Flavopiridol.
- Physical exam
- Blood tests
- Close urine monitoring that may require a Foley (urinary) catheter
- Close blood monitoring for blood salt levels (potassium)
- Bone marrow biopsy and aspirate to evaluate the leukemia
What are the benefits?
Patients may receive no direct benefit from participating in this study. The potential benefit is that Flavopiridol may cause the leukemia to stop growing or go into partial remission for a period of time or it may lessen symptoms. The biggest benefit is that patients may be helping other children. Clinical studies are essential in finding new and improved treatments and diagnostic tools.
Will I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
A detailed list of side effects can be provided to those patients interested in knowing more about the study.
Who should I contact for more information?
Rebecca Turner, MS, CCRP
Cincinnati Children's Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org
