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Trial Summary

Protocol No.PHO-CROOP-COG-ADVL1513
StatusOPEN TO ACCRUAL
Principal InvestigatorCroop, James
ScopeNational
PhasePhase I
Age GroupChildren
TitleA PHASE 1 STUDY OF ENTINOSTAT, AN ORAL HISTONE DEACETYLASE INHIBITOR, IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS, INCLUDING CNS TUMORS AND LYMPHOMA
DescriptionThis phase I trial studies the side effects and best dose of entinostat in treating pediatric patients with solid tumors that have come back or have not responded to treatment. Entinostat may block some of the enzymes needed for cell division and it may help to kill tumor cells.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patients with recurrent or refractory solid tumors, including central nervous system (CNS) tumors or lymphoma, are eligible; 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 cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
  • 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
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesChildhood Cancers
Participating InstitutionsIndiana University (IU)
  • Riley Hospital for Children
Treatment TypeTreatment
ContactMelissa Lee, Phone: +1 317-944-4281
Pager: 312-1228
Email: mellee@iu.edu