Leukemia Clinical Trial
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
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | October 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | M.D. Anderson Cancer Center at University of Texas | Houston | Texas |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biological efficacy by measuring surrogate end-points, including cellular cholesterol, messenger RNAs encoding cholesterol synthesis and cholesterol import regulators, and specific protein farnesylation | No | ||
Primary | Leukemia cell apoptosis | No | ||
Primary | Maximum tolerated dose (MTD) of pravastatin | Yes | ||
Primary | Maximal biological effect on cholesterol metabolism achieved with or without the MTD of pravastatin | Yes |
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