| SWOG-S0919 | A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Relapsed Acute Myelogenous Leukemia (1738)-
Eligibility: click to view information
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 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
- Consent Forms: S0919 Consent
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