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

DISEASE CHARACTERISTICS:

• Morphologically confirmed diagnosis of acute myeloid leukemia (AML)

• Must have received ≥ 1 prior chemotherapy regimen for AML

  • Any type of prior chemotherapy allowed

  • Must have achieved a complete remission (CR) (including CR with incomplete recovery) that lasted ≥ 3 months after the last induction regimen and then subsequently relapsed

    • Relapse must be documented by a bone marrow examination demonstrating > 5% blasts in the bone marrow not attributable to another cause
• No acute promyelocytic leukemia (i.e., APL, FAB M3) or blastic transformation of chronic myelogenous leukemia
• No clinical evidence of leptomeningeal disease
• Concurrent registration on research study SWOG-9007 required

PATIENT CHARACTERISTICS:

• 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
• Ejection fraction ≥ 45% by echocardiogram or MUGA scan
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias

• 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 despite appropriate antibiotics or other treatment
• Other prior malignancy allowed provided patient is in remission from that malignancy

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 6 months since prior chemotherapy or radiotherapy and recovered
• No prior autologous or allogeneic stem cell transplantation
• Prior or concurrent hydroxyurea to control high WBC counts allowed
• No concurrent statin treatments