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.
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
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. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Childhood Brain Stem Neoplasm Childhood Lymphoma Childhood Solid Neoplasm Pineal Region Neoplasm Recurrent Childhood Central Nervous System Neoplasm Recurrent Childhood Visual Pathway Glioma Refractory Central Nervous System Neoplasm Entinostat Histone Deacetylase Inhibitors
Open to people ages 12 months to 21 years
=14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy; additionally, patients must have fully recovered from all acute toxic effects of prior therapy; Note:cytoreduction with hydroxyurea must be discontinued>= 24 hours prior to the start of protocol therapy
= 16 years: 1.7 mg/dL for males and 1.4 mg/dL for females
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