S0919, A Phase II Study of Idarubicin and Ara-C in Combination With Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)

Inclusion Criteria

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