Phase I study of temsirolimus in pediatric patients with recurrent/refractory solid tumors.

ABSTRACT:

Purpose

To determine dose-limiting toxicities, maximum-tolerated dose (MTD), pharmacokinetics, and pharmacodynamics of weekly intravenous temsirolimus, a mammalian target of rapamycin (mTOR) signaling pathway inhibitor, in pediatric patients with recurrent or refractory solid tumors.

Patients and methods

Cohorts of three to six patients 1 to 21 years of age with recurrent or refractory solid tumors were treated with a 1-hour intravenous infusion of temsirolimus weekly for 3 weeks per course at one of four dose levels: 10, 25, 75, or 150 mg/m(2). During the first two courses, pharmacokinetic and pharmacodynamic evaluations (phosphorylation of S6, AKT, and 4EBP1 in peripheral-blood mononuclear cells) were performed.

Results

Dose-limiting toxicity (grade 3 anorexia) occu

SUBMITTER: Spunt SL 

PROVIDER: S-EPMC3138720 | biostudies-literature | 2011 Jul

REPOSITORIES: biostudies-literature