Phase I trial of lapatinib in children with refractory CNS malignancies: a Pediatric Brain Tumor Consortium study.

ABSTRACT:

Purpose

To estimate the maximum-tolerated dose, dose-limiting toxicities (DLTs), and pharmacokinetic properties of lapatinib, a selective epidermal growth factor receptor (EGFR) and ERBB2 inhibitor, in children with refractory or recurrent CNS malignancies.

Patients and methods

Lapatinib was administered orally twice daily at escalating doses starting at 300 mg/m(2) to patients who were not (stratum I) or were (stratum II) receiving steroids. Pharmacokinetic studies were performed during the first two courses. Expression of the four ERBB receptors and downstream signaling elements in tumor tissue was evaluated by immunohistochemistry.

Results

Fifty-nine patients were enrolled (stratum I, n = 32; stratum II, n = 27). Of 29 patients evaluable for toxicity in stratum I,

SUBMITTER: Fouladi M 

PROVIDER: S-EPMC2953974 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature