A phase-1 pharmacokinetic optimal dosing study of intraventricular topotecan for children with neoplastic meningitis: a Pediatric Brain Tumor Consortium study.

ABSTRACT:

Purpose

We performed a phase-1 pharmacokinetic optimal dosing study of intraventricular topotecan (IT), administered daily 5×, to determine whether, the maximum tolerated dose of IT topotecan was also the pharmacokinetic optimal dose.

Patients and methods

Patients received topotecan administered through an intraventricular access device (0.1 or 0.2 mg/dose), daily × 5 every other week 2× (Induction); every 3 weeks × 2 (Consolidation); then every 4 weeks for up to 11 courses (Maintenance). Ventricular CSF pharmacokinetic studies were performed on day 1, week 1 of induction, and in a subset of patients after a single intralumbar topotecan dose on day 1, week 3.

Results

Nineteen patients were enrolled. All were evaluable for toxicity and 18 were assessable for pharmacoki

SUBMITTER: Blaney SM 

PROVIDER: S-EPMC3573253 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature