Sirolimus in Combination With MEC in High Risk Myeloid Leukemias

Inclusion Criteria:

- Must have histologic evidence of advanced myeloid leukemias defined as one of the
following: primary refractory non-M3 AML; relapsed non-M3 AML; secondary AML;
intermediate or poor prognosis de novo AML in patients who are >= 60 years old

- >= 18 years of age

- ECOG performance status of 0, 1

- Able to consume oral medication

- Initial laboratory values: creatinine <= 2.0 mg/dL; total or direct bilirubin <=
1.5/dL; SGPT(ALT) <= 3xULN; negative pregnancy test for women with child-bearing
potential

- Ejection fraction of >= 45%

Exclusion Criteria:

- Subjects with FAM B3

- Must not be receiving chemotherapy (except Hydroxyurea)

- Not receiving growth factors, except for erythropoietin

- Subjects with a "currently active" second malignancy other than non-melanoma skin
cancers

- Subjects with uncontrolled high blood pressure, unstable angina, symptomatic
congestive heart failure, MI within the last 6 months or uncontrolled cardiac
arrhythmia

- Subjects taking diltiazem

- Subjects who require HIV protease inhibitors or those with AIDS-related illnesses

- No evidence of cerebellar dysfunction at baseline or during prior cytarabine therapy

- Not pregnant or breastfeeding

- Uncontrolled infection

- Subjects taking Carbamazepine, Rifabutin, Rifampin, Rifapentine, St. John's wort,
Clarithromycin, Cyclosporine, Diltiazem, Erythromycin, Telithromycin, Verapamil,
Tacrolimus