A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)

Relapsed/refractory pts must have previous morphologically confirmed AML diagnosis. MDS transformed to AML pts must have previous morphologically confirmed MDS diagnosis. Pts may have received previous non-intensive therapy for MDS (w/up to 20% blasts). At reg they must have morphologically confirmed AML diagnosis.
Pts with APL (APL, FAB, M3) or blastic transformation of CML are not eligible.

Relapsed/refractory AML patients must meet all of the following:
-At least 1 prior induction for AML (any type of chemo, hydroxyurea for high WBC permitted)
-Relapse/refractory disease must be documented by marrow exam w/ > 5% blasts in marrow not attributable to another cause
-Pts must NOT have received chemo within 14 days prior to reg
-Pts must NOT have auto or allo transplant

Primary refractory pts eligible if, on D14 of previous chemo, they have significant residual disease. Pts who received only hypomethylating agent or low dose therapy for induction are not primary refractory for purposes of this study and are not eligible.

Relapsed pts must have achieved CR or CRi lasting < 6 months with last induction.



Pts must not have symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias. Either an ECG or MUGA scan with an EF </= 45% must be obtained within 28 days prior to registration, or within 14 days prior to reg if pt has received anthracycline in the 28 day window. If patient has symptoms suggestive of ischemia or congestive heart failure after that cardiac evaluation was done, a repeat study must be obtained prior to registration.

Pts must have a serum creatinine < 2.0 mg/dl within 14 days prior to registration. Pts

Patients must have bilirubin </= 2.0 x IULN within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis and not to liver dysfunction.

Pts must have SGOT </= 3.0 x IULN and SGPT </= 3.0 x IULN within 14 days prior to registration. Treatment may begin with SGOT/SGPT above those limits, if the abnormalities are thought to be due to the patient’s leukemia. Patients must have

Zubrod PS of 0-2.

Pts must be >/= 18 years of age.

Pts must not have clinical evidence of leptomeningeal disease (a spinal tap does not need to be performed).

Pts not known to be HIV+ must be tested for HIV infection within 14 days prior to registration. Patients who are HIV+ may be eligible providing they meet all of additional criteria outlined within 14 days prior to registration. Patients who are HIV+ and do not meet all of the outlined criteria will not be eligible for this study.

Pts with prior malignancy (other than AML and MDS) are eligible. However, the patient must be in remission from the prior malignancy and have completed all chemotherapy and radiotherapy at least 6 months prior to registration and all treatment related toxicities must have been resolved.

Pts must not have a systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).

Pts must have pretreatment cytogenetics specimens submitted to the site preferred lab. Collection of pretreatment marrow specimens must be completed within 28 days prior to registration.

Women of reproductive potential must have a negative pregnancy test within 14 days prior to registration. Patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study. Women/men of reproductive potential must have agreed to use an effective contraceptive method.

All pts must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

At the time of pt registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base.