ADVL1513: Entinostat for Children with Recurrent or Refractory Solid Tumors

A Phase I Study of Entinostat, an Oral Histone Deacetylase Inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors and Lymphoma

Categories:

Solid Tumor

Phase I/II

Diseases Treated:

Solid Tumor, CNS Tumor, Lymphoma

Eligibility Overview:

  • 12 months to 21 years old
  • Able to swallow whole tablets
  • Diagnosis of recurrent or refractory solid tumor, including CNS tumor and lymphoma
  1. Brief Summary

    This Phase I study will examine the safety and pharmacokinetics of single-agent oral entinostat in children and young adults with refractory or recurrent solid tumors, including CNS tumors and lymphoma. Entinostat is a novel, oral small molecule inhibitor of class I histone deactylases (HDAC). It has shown anti-tumor activity against a variety of pediatric cancer cells lines, including rhabdomyosarcoma, neuroblastoma, Ewing sarcoma, retinoblastoma, osteosarcoma, and medulloblastoma. There have been no prior pediatric studies of entinostat. 

    Primary Objectives

    • To estimate the maximum tolerated dose (MTD) and/or recommended Phase II dose of entinostat administered as a single-agent, once weekly
    • To define and describe the toxicities of entinostat
    • To characterize the pharmacokinetics of entinostat

    Eligibility Criteria

    Inclusion criteria include:

    • 12 months to 21 years old
    • Able to swallow whole tablets
    • Diagnosis of recurrent or refractory solid tumor, including CNS tumor and lymphoma
    • Recovered from acute toxic effects of prior anti-cancer therapy 
    • No known curative therapy or therapy proven to prolong survival with an acceptable quality of life

    Exclusion Criteria include:

    • Pregnancy or breastfeeding
    • Currently receiving another investigational drug
    • Currently receiving other anti-cancer agents
    • History of allergy to medications that have a benzamide structure (e.g., metoclopramide, procarbazine, domperidone, cisapride)

    Study Sites

    St. Jude Children's Research Hospital
    Memphis, Tennessee

    Collaborating sites in the U.S.

  2. About this study

    This clinical trial is a research study of an experimental drug for cancer. The drug is called entinostat. It is considered experimental because it has not been proven to work in children and young adults with solid tumors that have come back (recurrent) or are hard to treat (refractory). Entinostat seems to work against cancer in laboratory studies. It has been used in adults, but it has not been approved for use in children. This study will test entinostat in children and young adults with hard-to-treat solid tumors.

    Purpose of this clinical trial

    The main purpose of this study is to find the highest dose of entinostat that may be given safely without causing severe side effects. Researchers also want to learn more about how the body handles the drug. Finally, they want to see how well entinostat treats recurrent and refractory solid tumors in children and young adults.

    Eligibility overview

    • 12 months to 21 years old
    • Able to swallow whole tablets
    • Diagnosis of recurrent or refractory solid tumor, including CNS tumor and lymphoma
  3. ADVL1513 Quick View
    Sponsors Children's Oncology Group
    ClinicalTrials.gov identifier NCT02780804
    Trial Start Date December 2016
    Estimated Enrollment 36
    Study Type Interventional
    Study Phase Phase I
    Conditions Solid tumors
    Ages 12 months to 21 years old
    Principal investigator Wayne Furman, MD (St. Jude)
    Study Sites St. Jude Children's Research Hospital and collaborating sites in the U.S.
    For a consultation or to discuss ADVL1513 St. Jude Physician/Patient Referral
    Office 1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

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