MK2206 in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Leukemia
Condition: Accelerated Phase Chronic Myelogenous Leukemia; Acute Leukemias of Ambiguous Lineage; Acute Myeloid Leukemia/Transient Myeloproliferative Disorder; Acute Undifferentiated Leukemia; Aggressive NK-cell Leukemia; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blastic Phase Chronic Myelogenous Leukemia; Blastic Plasmacytoid Dendritic Cell Neoplasm; Childhood Burkitt Lymphoma; Childhood Chronic Myelogenous Leukemia; Childhood Diffuse Large Cell Lymphoma; Childhood Grade III Lymphomatoid Granulomatosis; Childhood Immunoblastic Large Cell Lymphoma; Childhood Nasal Type Extranodal NK/T-cell Lymphoma; Chronic Eosinophilic Leukemia; Chronic Myelomonocytic Leukemia; Chronic Neutrophilic Leukemia; Chronic Phase Chronic Myelogenous Leukemia; Intraocular Lymphoma; Juvenile Myelomonocytic Leukemia; Mast Cell Leukemia; Myeloid/NK-cell Acute Leukemia; Noncutaneous Extranodal Lymphoma; Post-transplant Lymphoproliferative Disorder; Primary Central Nervous System Hodgkin Lymphoma; Primary Central Nervous System Non-Hodgkin Lymphoma; Progressive Hairy Cell Leukemia, Initial Treatment; Prolymphocytic Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Childhood Grade III Lymphomatoid Granulomatosis; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Small Noncleaved Cell 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; Recurrent/Refractory Childhood Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Relapsing Chronic Myelogenous Leukemia; Secondary Acute Myeloid Leukemia; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific; Waldenström Macroglobulinemia
MeSH terms: Burkitt Lymphoma; Mycoses; Lymphoma; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Hodgkin Disease; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Mycosis Fungoides; Leukemia, Myelomonocytic, Acute; Leukemia, Myelomonocytic, Chronic; Sezary Syndrome; Waldenstrom Macroglobulinemia; Leukemia, Myelomonocytic, Juvenile; Lymphoma, Large-Cell, Anaplastic; Leukemia, Hairy Cell; Leukemia, Myeloid, Chronic-Phase; Blast Crisis; Lymphomatoid Granulomatosis; Leukemia, Myeloid, Accelerated Phase; Lymphoma, Extranodal NK-T-Cell; Leukemia, Prolymphocytic; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Intraocular Lymphoma; Leukemia, Mast-Cell; Leukemia, Large Granular Lymphocytic; Lymphoproliferative Disorders; Myeloproliferative Disorders; Hypereosinophilic Syndrome; Leukemia, Neutrophilic, Chronic; Recurrence; Acute Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial is studying the side effects, best way to give, and best dose of Akt
      inhibitor MK2206 (MK2206) in treating patients with recurrent or refractory solid tumors or
      leukemia. MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed
      for cell growth.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      l. To estimate the maximum-tolerated dose (MTD) and/or recommended phase 2 dose of MK-2206
      (Akt inhibitor MK2206) administered orally every other day (schedule 1) or once weekly
      (schedule 2) to children with refractory or recurrent solid malignancies, including central
      nervous system (CNS) tumors or lymphomas.

      II. To define and describe the toxicities of MK-2206 in children with refractory solid
      malignancies administered on this schedule.

      III. To assess the tolerability of MK-2206 at the solid tumor MTD in patients with recurrent
      or refractory leukemia.

      IV. To characterize the pharmacokinetics of MK-2206 in children with recurrent or refractory
      cancer. (exploratory)

      SECONDARY OBJECTIVES:

      I. To preliminarily define the antitumor activity of MK-2206 within the confines of a phase 1
      study.(exploratory) II. To evaluate biological activity of MK-2206 by measuring
      phosphatidylinositol 3 kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin
      (mTOR) signaling in tumor and peripheral blood mononuclear cells and measure the expression
      of biomarkers related to AKT activation phenotypes. (exploratory)

      OUTLINE: This is a dose-escalation study (part A) followed by treatment at the
      maximum-tolerated dose (part B).

      Patients receive Akt inhibitor MK2206 orally (PO) every other day (schedule 1) OR once weekly
      (schedule 2) on days 1-28. Treatment repeats every 28 days for up 12 courses (1 year) in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 30 days.
    

Intervention name(s): Akt inhibitor MK2206; diagnostic laboratory biomarker analysis; pharmacological study
Intervention type(s): Drug; Other; Other
Intervention description(s): Given PO; Correlative studies; Correlative studies
Other intervention name(s): MK2206; pharmacological studies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment