Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02780804|
Recruitment Status : Active, not recruiting
First Posted : May 24, 2016
Last Update Posted : January 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Entinostat Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 26, 2016|
|Estimated Primary Completion Date :||April 30, 2022|
Experimental: Treatment (entinostat)
Patients receive entinostat 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.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Maximum tolerated dose [ Time Frame: Up to 28 days ]Will be defined as the maximum dose at which fewer than one-third of patients experience dose limiting toxicity during cycle 1 of therapy. Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Incidence of adverse events [ Time Frame: Up to 28 days ]Will be described and graded using CTCAE version 5.0. A descriptive summary of all toxicities will be reported.
- Changes in pharmacokinetic (PK) parameters [ Time Frame: Pre-dose on days 1, 8, and 22 and 1, 3 ,6, 24, 48 and 96 hours post-dose on day 1, and day 28 ]A descriptive analysis of PK parameters of entinostat will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- Antitumor activity of entinostat [ Time Frame: Up to 12 months ]
- Change in histone H3 and H4 acetylation [ Time Frame: Up to 12 months ]Will be assessed in peripheral blood mononuclear cells.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780804
|Principal Investigator:||Andrew Bukowinski||COG Phase I Consortium|