Pravastatin, Idarubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Treatments: Cytarabine; Idarubicin; Pravastatin

Criteria

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