Status:
COMPLETED
Pravastatin, Idarubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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. Prav...
Detailed Description
OBJECTIVES: * Determine the biological efficacy of pravastatin in leukemia cells, in terms of measuring surrogate endpoints, including cellular cholesterol, messenger RNA encoding cholesterol synthes...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:
- Newly diagnosed disease (MDACC patients only)
- In first or second relapse AND scheduled to receive first salvage therapy
- Primary refractory disease after prior induction therapy for newly diagnosed disease
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- AST or ALT ≤ 2 times normal
- Alkaline phosphatase ≤ 2 times normal
- Bilirubin \< 2.0 mg/dL
- No acute or chronic hepatic impairment
- Renal
- Creatinine \< 1.5 times normal (unless secondary to acute myeloid leukemia)
- Cardiovascular
- Ejection fraction (EF) ≥ 45% by MUGA or 2-D echocardiogram
- Patients who have an EF \< 45% OR cardiac symptoms must be evaluated and cleared by cardiology to be eligible for study entry
- No cardiac contraindication to idarubicin
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00107523
Start Date
January 1 2005
End Date
October 1 2005
Last Update
September 21 2010
Active Locations (2)
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1
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
2
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024