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Pediatric Studies

MK-2206 for Recurrent or Refractory Solid Tumors or Leukemia (COG-ADVL1013)
A Phase I Study of MK-2206, an AKT Inhibitor, in Pediatric Patients With Recurrent or Refractory Solid Tumors or Leukemia
Status Conditions Phase Study ID
Recruiting Brain and Central Nervous System Tumors
Leukemia
Lymphoma
Lymphoproliferative Disorder
Small Intestine Cancer
Phase I COG-ADVL1013
NCT01231919
Summary

RATIONALE: MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of MK2206 in treating patients with recurrent or refractory solid tumors or leukemia.


Investigator
Julie Park, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

 

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis meets one of the following criteria:

    • Part A (both schedules):

      • Patients must have a diagnosis of recurrent or refractory solid tumors, including CNS tumors or lymphoma
      • Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of CSF or serum tumor markers, including alpha-fetoprotein or beta-HCG
    • Part B (both schedules):

      • Patients must have a diagnosis of recurrent or refractory leukemia
  • Patients with solid tumors must have either measurable or evaluable disease
  • Patients with leukemia must have ≥ 5% blasts in the bone marrow

    • Active extramedullary disease (except for leptomeningeal disease) may also be present
  • Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
  • Slides or tissue blocks from either initial diagnosis or relapse must be available for central review (if tissue blocks or slides are unavailable, the study chair must be notified prior to study enrollment)

PATIENT CHARACTERISTICS:

  • Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50% for patients ≤ 16 years of age

    • Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
  • For patients with solid tumors without known bone marrow involvement including patients who are status post-stem cell transplantation:

    • Peripheral absolute neutrophil count (ANC) ≥ 1,000/mm^3
    • Platelet count ≥ 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment)
  • For patients with solid tumors with known bone marrow metastatic disease*:

    • These patients are eligible for study provided they meet the blood count criteria above and are not known to be refractory to red cell or platelet transfusions NOTE: *These patients are not evaluable for hematologic toxicity.
  • For patients with leukemia (part B):

    • Blood counts are not required to be normal prior to enrollment on this trial, however, platelet count has to be ≥ 20,000/mm^3 (may receive platelet transfusions)
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min^2 OR a serum creatinine based on age/gender as follows:

    • ≤ 0.6 mg/dL (for patients 1 to < 2 years old)
    • ≤ 0.8 mg/dL (for patients 2 to < 6 years old)
    • ≤ 1 mg/dL (for patients 6 to < 10 years old)
    • ≤ 1.2 mg/dL (for patients 10 to < 13 years old)
    • ≤ 1.4 mg/dL (for female patients ≥ 13 years old)
    • ≤ 1.5 mg/dL (for male patients 13 to < 16 years old)
    • ≤ 1.7 mg/dL (for male patients ≥ 16 years old)
  • Bilirubin (sum of unconjugated + conjugated) ≤ 1.5 x upper limit of normal (ULN) for age
  • SGPT (ALT) ≤ 110 U/L for patients with solid tumors OR SGPT (ALT) ≤ 225 U/L for patients with leukemias (for the purpose of this study, the ULN for SGPT is 45 U/L)
  • Serum albumin ≥ 2 g/dL
  • QTc ≤ 450 msec
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Patients must be able to swallow whole tablets

    • Nasogastric or G-tube administration is not allowed
  • Patients must have a body surface area > 0.5 m^2 when enrolling on dose levels 0 or 1 of the every other day schedule

    • No BSA restrictions apply to patients enrolling on higher dose levels
    • No BSA restrictions apply to patients enrolling on any dose level of the weekly schedule
  • Patients with seizure disorder may be enrolled if on non-enzyme-inducing anticonvulsants and well controlled
  • Nervous system disorders (CTCAE v4) resulting from prior therapy must be ≤ grade 2
  • Patients who have an uncontrolled infection are not eligible
  • Patients with known type I or type II diabetes mellitus are not eligible
  • Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible

PRIOR CONCURRENT THERAPY:

  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy
  • Patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
  • Patients with leukemia who relapse while receiving standard maintenance chemotherapy will not be required to have a waiting period before enrollment onto this study
  • Patients with leukemia who relapse while they are not receiving standard maintenance therapy, must have fully recovered from all acute toxic effects of prior therapy

    • At least 14 days must have elapsed since the completion of cytotoxic therapy, with the exception of hydroxyurea
    • Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of MK-2206
  • At least 14 days after the last dose of a long-acting growth factor (e.g., Neulasta) or 7 days for short-acting growth factor

    • For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur (the duration of this interval must be discussed with the study chair)
  • At least 7 days after the last dose of a biologic agent

    • For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur (the duration of this interval must be discussed with the study chair)
  • At least 6 weeks since the completion of any type of immunotherapy (e.g., tumor vaccines)
  • At least 3 half-lives of the antibody after the last dose of a monoclonal antibody
  • At least 2 weeks for local palliative XRT (small port); ≥ 24 weeks must have elapsed if prior TBI, craniospinal XRT, or if ≥ 50% radiation of pelvis; ≥ 6 weeks must have elapsed if other substantial BM radiation
  • No evidence of active graft vs host disease and ≥ 8 weeks must have elapsed since transplant or stem cell infusion without TBI
  • At least 3 months since bone marrow transplantation
  • Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the prior 7 days are not eligible
  • Patients who are currently receiving another investigational drug are not eligible
  • Patients who are currently receiving other anticancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy)

    • Patients with leukemia may receive intrathecal therapy
  • Patients must not be receiving enzyme-inducing anticonvulsants
  • Patients receiving insulin or growth hormone therapy are not eligible
  • Patients on medications that may cause QTc interval prolongation are not eligible
  • Patients who are receiving cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post-bone marrow transplant or organ rejection post-transplant are not eligible for this trial
  • Other concurrent cancer therapy, including chemotherapy, radiation therapy, immunotherapy, or biologic therapy may NOT be administered to patients receiving study drug
Last Updated
February 29, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.