This phase II trial is studying how well AKT inhibitor MK-2206 works in treating patients with relapsed or refractory acute myeloid leukemia (AML). AKT inhibitor MK-2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. Determine the proportion of patients achieving Morphologic Complete Response (CR), Morphologic CR with incomplete count recovery (CRp) or Partial Response (PR) as best response within 3 cycles of therapy with MK-2206. SECONDARY OBJECTIVES: I. Describe the disease-free survival of patients that achieve CR/CRp. II. Determine the toxicity profile of single-agent MK-2206 in this patient population. III. To determine the biologic effects of MK-2206 on leukemia cells. OUTLINE: Patients receive AKT inhibitor MK-2206 orally (PO) once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
200 mg orally (PO) once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Correlative studies
UT MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Number of Participants With a Response of CR, CRp, or PR
Responses defined by International Working Group (IWG) 2003 Response Criteria: Morphologic Complete Response (CR): Peripheral blood counts: No circulating blasts, Neutrophil count \>/= 1.0 x10\^9/L, Platelet count \>/= 100 x10\^9/L; Bone marrow aspirate and biopsy: \</= 5% blasts, No detectable Auer rods, No extramedullary leukemia. Partial Response (PR): No circulating blasts, Neutrophil count \>/=1.0 x10\^9/L, Platelet count \>/= 100 x10\^9/L, \>/= 50 % reduction in bone marrow blast to 6% to 25%, or blasts \</= 5% if Auer rods are present. Morphologic CR with incomplete count recovery (CRp): All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L).
Time frame: 12 weeks of treatment
Number of Participants With Treatment-related Non-hematological Toxicity
Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 4.0 (CTCAEv4.0)
Time frame: Up to 30 days post-treatment
Maximum Percentage Change in Apoptosis
Peripheral blood Acute Myeloid Leukemia (AML) cells (total 2 x 10\^6) used to determine induction of apoptosis in AML stem cells by 4-color flow cytometry assay (CD34/CD38/CD123/annexin). Two-sample t-test conducted to compare changes between the responders and non-responders. Responders are participants who obtain a CR, CRp, or PR, with or without cytogenetic response.
Time frame: Baseline to 12 courses
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