ADVL1513, A Phase 1 Study of Entinostat, an Oral Histone Deacetylase Inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors and Lymphoma

This 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.

Principal Investigator:
Ivan Kirov, MD

Research Coordinator:
Kathryn Duvall
(714) 509-8646

Visit clinicaltrials.gov for more information about this trial.



  • Clinical Trial Info
  • IRB Number: 170103
  • Sponsor: Children's Oncology Group
  • Protocol Number: ADVL1513
  • NCT Number: NCT02780804
  • Research Type: Adolescents and Young Adults, Brain Tumor/Central Nervous System/Neuro-Oncology, Recurrent/Refractory Cancer, Solid Tumors
  • Phase: I
  • Status: Active - Open to Enrollment

Key Inclusion Criteria:

  • Patients must have a body surface area (BSA) of >= 1.17 m^2 at time of study enrollment
  • Patients must be able to swallow intact tablets
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment
  • Standard COG Phase 1 organ function requirements

Key Exclusion Criteria:

  • Patients requiring concurrent administration of valproic acid
  • Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant
  • Patients who are not able to swallow intact tablets are not eligible

 

Long Live Childhood

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