Phase 1 study of valproic acid in pediatric patients with refractory solid or CNS tumors: a children's oncology group report.

ABSTRACT:

Purpose

The primary purpose of this trial was to define and describe the toxicities of oral valproic acid (VPA) at doses required to maintain trough concentrations of 100 to 150 mcg/mL or 150 to 200 mcg/mL in children with refractory solid or central nervous system (CNS) tumors. Secondary objectives included assessment of free and total VPA pharmacokinetics (PKs) and histone acetylation in peripheral blood mononuclear cells (PBMC) at steady state.

Patients and methods

Oral VPA, initially administered twice daily and subsequently three times daily, was continued without interruption to maintain trough concentrations of 100 to 150 mcg/mL. First-dose and steady-state PKs were studied. Histone H3 and H4 acetylation in PBMCs was evaluated using an ELISA technique.

Results

SUBMITTER: Su JM 

PROVIDER: S-EPMC3064523 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature