NCT02780804

Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 12 Months – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of entinostat administered as a single-agent, once weekly to children with recurrent or refractory solid tumors. II. To define and describe the toxicities of entinostat administered as a single agent, once weekly to children with recurrent or refractory solid tumors. III. To characterize the pharmacokinetics of entinostat in children with recurrent or refractory cancer. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of entinostat within the confines of a phase 1 study. II. To assess change in histone H3 and H4 acetylation in peripheral blood mononuclear cells (PBMCs) as a marker of the biologic activity of entinostat. OUTLINE: This is a dose escalation study. Patients receive entinostat orally (PO) on days 1, 8, 15, and 22. Cycles repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Conditions

• Brain Stem Neoplasm
• Pineal Region Neoplasm
• Recurrent Lymphoma
• Recurrent Malignant Solid Neoplasm
• Recurrent Primary Central Nervous System Neoplasm
• Recurrent Visual Pathway Glioma
• Refractory Lymphoma
• Refractory Malignant Solid Neoplasm
• Refractory Primary Central Nervous System Neoplasm
• Refractory Visual Pathway Glioma

Interventions

Type	Name	Description
DRUG	Entinostat	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2017-01-06
• Primary completion: 2021-06-30
• Completion: 2021-09-30
• First posted: 2016-05-24
• Last updated: 2023-10-17
• Results posted: 2023-01-31

Locations

21 sites across 1 country: United States