S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia

Cohort 1 (Initial cohort: Relapsed AML with previous remission >/= 3 months) is permanently closed to accrual DISEASE CHARACTERISTICS

• Patients must have a previous morphologically confirmed diagnosis of acute myeloid leukemia (AML). Note: This protocol uses the World Health Organization (WHO) diagnostic criteria for acute myeloid leukemia (AML) (see Section 4.1). Patients with acute promyelocytic leukemia (APL, FAB, M3) or blastic transformation of chronic myelogenous leukemia (CMML) are not eligible.
• Patients must have received at least one prior chemotherapy regimen for their acute myeloid leukemia (AML) and they may have received any type of chemotherapy. They must have achieved complete remission (CR), lasting at least three months with their last induction regimen and they must have relapsed after the last regimen. Relapse must be documented by a bone marrow examination demonstrating > 5% blasts in the bone marrow not attributable to another cause. Refractory patients and patients who have received autologous or allogeneic stem cell transplantation are not eligible. Administration of hydroxyurea to control high white blood cell (WBC) count prior to, during and after registration is permitted.
• Patients must not have symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias. Either an echocardiogram or multiple-gated acquisition (MUGA) scan with an ejection fraction ≥ 45% must be obtained within 28 days prior to registration. (Either method for measuring cardiac function is acceptable, however, the same scan must be used throughout treatment and follow-up to monitor the patient for cardiac toxicity.) 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.
• Patients must have a serum creatinine 5% blasts in the bone marrow not attributable to another cause
• Patient must not have received chemo within 14 days prior to registration
• Primary refractory patients eligible if, on Day 14 of previous chemo regimen, they have significant residual disease. Patients who received only hypomethylating agent or low dose therapy for Induction are not considered primary refractory for this study and are not eligible.
• Relapsed patients must have achieved a complete remission (CR) or CR with incomplete blood count recovery that lasted < 6 months after the last induction regimen
• No clinical evidence of leptomeningeal disease
• Pretreatment (collected within 28 days of registration) cytogenetics must be performed on all patients.
• Patients must have complete history and physical exam within 28 days prior to registration.

PATIENT CHARACTERISTICS:

• No symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias
• Ejection fraction ≥ 45% by echocardiogram or MUGA scan within 28 days prior to registration (or within 14 days prior to registration if the patient has received anthracycline in the 28 day window)
• Zubrod performance status 0-2
• Serum creatinine ≤ 2.0 times upper limit of normal (ULN)
• Total bilirubin ≤ 2.0 times ULN (unless elevation is primarily due to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis AND not due to liver dysfunction)
• AST and ALT ≤ 3.0 times ULN
• Not pregnant or nursing and negative pregnancy test within 14 days prior to registration. Females of child-bearing potential must agree to use effective contraception
• No HIV positivity unless the following criteria are met:
• No history of AIDS-defining events
• CD4 count ≥ 500/mm³
• Viral load < 25, 000 copies (< 50 copies if on combination antiretroviral therapy)
• Not receiving zidovudine or stavudine as part of combination antiretroviral therapy
• No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as exhibiting ongoing signs/symptoms related to the infection with no improvement