Study of Akt Inhibitor MK2206 in Patients With Relapsed Lymphoma
Condition: Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; B-cell Adult Acute Lymphoblastic Leukemia; B-cell Chronic Lymphocytic Leukemia; Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Noncutaneous Extranodal Lymphoma; Peripheral T-cell Lymphoma; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Refractory Hairy Cell Leukemia; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; T-cell Adult Acute Lymphoblastic Leukemia; T-cell Large Granular Lymphocyte Leukemia; Testicular Lymphoma; Waldenström Macroglobulinemia
MeSH terms: Mycoses; Lymphoma; Leukemia; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Hodgkin Disease; Lymphoma, Mantle-Cell; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Mycosis Fungoides; Sezary Syndrome; Leukemia, T-Cell; Lymphoma, T-Cell, Cutaneous; Waldenstrom Macroglobulinemia; Leukemia-Lymphoma, Adult T-Cell; Lymphoma, Large-Cell, Anaplastic; Leukemia, Hairy Cell; Lymphomatoid Granulomatosis; Lymphoma, Extranodal NK-T-Cell; Intraocular Lymphoma; Leukemia, Large Granular Lymphocytic; Immunoblastic Lymphadenopathy; Recurrence
Intervention: Akt inhibitor MK2206; laboratory biomarker analysis
Intervention description: Given PO; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients
      with relapsed lymphoma. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking
      some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) (small
             lymphocytic lymphoma may be included)

          -  Relapsed or refractory after at least one regimen and with no curative option with
             conventional therapy

          -  Bidimensionally measurable disease (at least 2 cm)

          -  No evidence of cerebral or meningeal involvement by lymphoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

          -  Signed informed consent form prior to enrollment

          -  Women of childbearing potential and men must use two forms of contraception (hormonal
             or barrier method of birth control; abstinence) prior to study entry and for the
             duration of study participation; should a women become pregnant or suspect she is
             pregnant while she or her partner is participating in this study, the patient should
             inform the treating physician immediately

        Exclusion Criteria:

          -  Burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia and cutaneous
             T-cell lymphoma

          -  Chemotherapy or radiation therapy or other investigational agents within 3 weeks prior
             to entering the study unless there is clear evidence of progression of disease and
             toxicity from previous treatment has resolved in which case study entry may be within
             1 week of last treatment

          -  Previous radioimmunotherapy within 12 weeks

          -  Patients with known immunodeficiency virus (HIV) infection must not have cluster of
             differentiation (CD)4 cells < 400/mm^3 and who must not have a prior acquired
             immunodeficiency syndrome (AIDS)-defining diagnosis and cannot be on antiretroviral
             therapy for HIV

          -  Known active viral hepatitis

          -  Any serious active disease or co-morbid condition, which in the opinion of the
             principal investigator, will interfere with the safety or with compliance with the
             study

          -  Absolute neutrophil count < 1.5 x 10^9/L

          -  Platelets < 75 x 10^9/L

          -  Total bilirubin > 1.5 x upper limit of normal (ULN) (> 3 x ULN for patients with liver
             involvement)

          -  Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 2.5 x ULN (> 5 x
             ULN for patients with liver involvement)

          -  Serum creatinine > 2 x ULN

          -  Hemoglobin (Hb)A1C > 8%

          -  Patients receiving any medications or substances that are inhibitors of cytochrome
             P450 family 3, subfamily A, polypeptide 4 (CYP 450 3A4) are ineligible

          -  Patients with diabetes or in risk for hyperglycemia should not be excluded from trials
             with MK-2206, but the hyperglycemia should be well controlled on oral agents before
             the patient enters the trial

          -  Cardiovascular: baseline Fredericia corrected QT interval (QTcF) > 450 msec (male) or
             QTcF > 470 msec (female) will exclude patients from entry on study

          -  Significant heart block or baseline bradycardia < 50 beats per minute (bpm) due to
             cardiac disease

          -  Patients who are pregnant or breastfeeding