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Sponsored by: |
Fred Hutchinson Cancer Research Center |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00107523 |
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving pravastatin together with idarubicin and cytarabine may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of pravastatin when given together with idarubicin and cytarabine in treating patients with acute myeloid leukemia.
Condition | Intervention | Phase |
Leukemia |
Drug: cytarabine Drug: idarubicin Drug: pravastatin |
Phase I |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
ChemIDplus related topics: | Cytarabine Cytarabine hydrochloride Idarubicin Idarubicin hydrochloride Pravastatin Pravastatin sodium |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Trial Evaluating the Effect of the Addition of HMGCoA-Reductase Inhibition With Pravastatin to Salvage Chemotherapy Idarubicin-HDAC in Patients With Relapsed or Refractory Acute Myelogenous Leukemia |
Study Start Date: | January 2005 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter, dose-escalation study of pravastatin.
Patients receive oral pravastatin once daily on days 1-8, idarubicin IV over 30 minutes on days 4-6, and high-dose cytarabine IV continuously on days 4-7. Treatment repeats every 28-42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete remission (CR) may receive additional treatment with the same doses of study drugs over fewer days. These patients receive oral pravastatin once daily on days 1-6 and idarubicin IV over 30 minutes and high-dose cytarabine IV continuously on days 4 and 5. Patients experiencing disease response with severe side effects may receive additional treatment at a lower dose of the study drug causing the side effects.
Cohorts of 3 patients receive escalating doses of pravastatin until the maximum tolerated dose (MTD)* is determined or a predetermined maximum dose is reached.
NOTE: *Patients achieving a CR with a dose of pravastatin that is subsequently determined to be above the MTD receive pravastatin at the MTD for all subsequent courses.
After completion of study treatment, patients are followed at least every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Ejection fraction (EF) ≥ 45% by MUGA or 2-D echocardiogram
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No other concurrent HMG-CoAR inhibitors, including any of the following:
No concurrent use of any of the following medications:
United States, Texas | |||||
M.D. Anderson Cancer Center at University of Texas | |||||
Houston, Texas, United States, 77030-4009 | |||||
United States, Washington | |||||
Fred Hutchinson Cancer Research Center | |||||
Seattle, Washington, United States, 98109-1024 |
Fred Hutchinson Cancer Research Center |
Principal Investigator: | Stephen H. Petersdorf, MD | Fred Hutchinson Cancer Research Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000419678, FHCRC-1945.00, MDA-2004-0185 |
First Received: | April 5, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00107523 |
Health Authority: | United States: Federal Government |
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