NCT00107523

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_1 leukemia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

First QC Date

April 5, 2005

Last Update Submit

September 20, 2010

Conditions

Leukemia

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)recurrent adult acute myeloid leukemiauntreated adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (4)

  • Biological efficacy by measuring surrogate end-points, including cellular cholesterol, messenger RNAs encoding cholesterol synthesis and cholesterol import regulators, and specific protein farnesylation

  • Leukemia cell apoptosis

  • Maximum tolerated dose (MTD) of pravastatin

  • Maximal biological effect on cholesterol metabolism achieved with or without the MTD of pravastatin

Interventions

cytarabineDRUG
idarubicinDRUG
pravastatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

LeukemiaCongenital AbnormalitiesLeukemia, Myeloid, Acute

Interventions

CytarabineIdarubicinPravastatin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesNaphthalenes

Study Officials

  • Stephen H. Petersdorf, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2005

First Posted

April 6, 2005

Study Start

January 1, 2005

Study Completion

October 1, 2005

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

US(2)