Pravastatin, Idarubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia
NCT ID: NCT00107523
Last Updated: 2010-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2005-01-31
2005-10-31
Brief Summary
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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.
Detailed Description
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* Determine the biological efficacy of pravastatin in leukemia cells, in terms of measuring surrogate endpoints, including cellular cholesterol, messenger RNA encoding cholesterol synthesis, cholesterol import regulators, and specific protein farnesylation, in patients with acute myeloid leukemia.
* Determine whether increasing doses of pravastatin, when administered with idarubicin and high-dose cytarabine, produce increased apoptosis in leukemia cells of these patients.
* Determine the maximum tolerated dose (MTD) of pravastatin when administered with idarubicin and high-dose cytarabine in these patients.
* Determine whether the MTD of pravastatin is required to achieve the maximal biological effect on cholesterol metabolism in leukemia cells of these patients.
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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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cytarabine
idarubicin
pravastatin
Eligibility Criteria
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Inclusion Criteria
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No uncontrolled or life threatening infection
* No known intolerance to study drugs
* Must be able to safely tolerate the 3-day delay between the start of pravastatin and the start of chemotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No other concurrent HMG-CoAR inhibitors, including any of the following:
* Atorvastatin
* Fluvastatin
* Lovastatin
* Rosuvastatin
* Simvastatin
* No concurrent non-HMG-CoAR inhibitors to lower cholesterol
* No concurrent use of any of the following medications:
* Bezafibrate
* Clofibrate
* Fenofibrate
* Gemfibrozil
* Cholestipol
* Cholestyramine resin
* Colesevelam
* Ezetimibe
* Biphenabid
* Niacin
18 Years
ALL
No
Sponsors
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Fred Hutchinson Cancer Center
OTHER
Principal Investigators
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Stephen H. Petersdorf, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
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M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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FHCRC-1945.00
Identifier Type: -
Identifier Source: secondary_id
MDA-2004-0185
Identifier Type: -
Identifier Source: secondary_id
CDR0000419678
Identifier Type: REGISTRY
Identifier Source: secondary_id
1945.00
Identifier Type: -
Identifier Source: org_study_id