AKT Inhibitor MK-2206 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Inclusion Criteria

• Patients must have histologically or cytologically confirmed AML other than acute promyelocytic leukemia (2008 World Health Organization (WHO) classification)
• Patients must have persistent or relapsing disease requiring 2nd salvage therapy (e.g. treatment for second or higher relapse or for primary refractory disease after failure of two prior treatment regimens); duration of prior complete remission 1 month and have no evidence of active graft versus host disease (GVHD) except grade 1 skin GVHD
• Patients age >= 60 years with less than two prior treatment regimens not candidates for or have refused standard chemotherapy, excluding subjects with acute promyelocytic leukemia (APL) or with favorable cytogenetic abnormalities [inv16, t(8;21)]
• Patient at the time of enrollment should not be a candidate for allogeneic stem cell transplantation
• The Eastern Cooperative Oncology Group (ECOG) performance status = = 60 mL/min for patients with creatinine levels > 1.5 * institutional ULN
• Serum total bilirubin = 2 * ULN, unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis
• asparate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT /SGPT) = grade 1
• Patients with central nervous system (CNS) involvement
• Patient has known hypersensitivity to the components of study drug or its analogs
• Uncontrolled congestive heart failure, unstable angina pectoris
• Uncontrolled cardiac arrhythmia
• History or current evidence of a myocardial infarction during the last 6 months
• corrected Q-T interval (QTc) prolongation > 450 msec (Bazett's Formula)
• Congenitally long QT syndrome, has received any marketed or experimental compound in the last 4 weeks or 5 half lives (whichever is shorter) prior to entering the study with possible or known effects of QT prolongation
• Patient with symptomatic bradycardia, or a history of clinically significant bradyarrhythmias such as sick sinus syndrome, 2nd degree AV block (Mobitz Type 2)
• Patient with uncontrolled hypertension (i.e., i.e., sustained systolic blood pressure >= 160 or diastolic >= 90); patients who are controlled on antihypertensive medication will be allowed to enter the study
• Patient with poorly controlled diabetes defined as HBA1C > 9%
• Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
• Patient is known to be Human Immunodeficiency Virus (HIV)-positive with history of AIDS defining conditions; or CD4 cells prior to leukemia onset =< 400 cells/mm^3; or patients receiving antiretroviral therapy that affects CYP3A4 such as protease inhibitors, efavirenz, nevirapine, or zidovudine
• Patient has active Hepatitis B or C or active Hepatitis A