Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia

Inclusion Criteria

• •1. Patients must have histologic evidence of high risk acute myeloid leukemia defined as one of the following:
• •1. Primary refractory non-M3 AML
• •* Residual leukemia after a minimum of 2 prior courses of chemotherapy (Same or different)
• •* Evidence of leukemia recurrence after a nadir bone marrow biopsy demonstrates no evidence of residual leukemia.
• •* Evidence of leukemia after induction therapy which, in the opinion of the investigator, would be appropriate for reinduction with sirolimus/MEC therapy.
• •2. Relapsed non-M3 AML
• •3. Previously untreated non-M3 AML age \>60 with no evidence of favorable karyotype defined by presence of t(8;21)(q22;q22) \[AML1-ETO\], inv16(p13;q22), or t(16;16)(p13;q22) \[CBFβ;MYH11\] by cytogenetics, FISH, or RT-PCR
• •4. Previously untreated secondary AML (from antecedent hematologic malignancy or following therapy with radiation or chemotherapy for another disease) with no evidence of favorable karyotype defined by presence of t(8;21)(q22;q22) \[AML1-ETO\], inv16(p13;q22), or t(16;16)(p13;q22) \[CBFβ;MYH11\] by cytogenetics, FISH, or RT-PCR
• •2. Subjects must be ≥ 18 years of age.
• •3. Subjects must have an ECOG performance status of 2 or less (see Appendix1).
• •4. Subjects must have a life expectancy of at least 4 weeks.
• •5. Subjects must be able to consume oral medication.
• •6. Subjects must have recovered from the toxic effects of any prior chemotherapy to =\< Grade 1 (except alopecia).
• •7. Required initial laboratory values:
• •1. Creatinine ≤ 2.0mg/dL
• •2. total or direct bilirubin ≤ 1.5mg/dL; SGPT (ALT) ≤ 3xULN
• •3. negative pregnancy test for women with child-bearing potential.
• •8. Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
• •9. Subjects must have a left ventricular ejection fraction (LVEF) of ≥ 45%.