Phase II trial of temsirolimus in children with high-grade glioma, neuroblastoma and rhabdomyosarcoma.

ABSTRACT:

Purpose

A phase II study of temsirolimus was conducted in children and adolescents with high-grade glioma, neuroblastoma or rhabdomyosarcoma.

Patients and methods

Temsirolimus 75 mg/m(2) was administered once weekly until disease progression or intolerance. Using the Simon 2-stage design, further enrolment in each disease cohort required ≥ 2 objective responses within the first 12 weeks for the first 12 evaluable patients (those who received ≥ 3 temsirolimus doses).

Results

Fifty-two heavily pretreated patients with relapsed (12%) or refractory (88%) disease, median age 8 years (range 1-21 years), were enroled and treated. One patient with neuroblastoma achieved confirmed partial response within the first 12 weeks; thus, none of the 3 cohorts met the criterion for con

SUBMITTER: Geoerger B 

PROVIDER: S-EPMC3539305 | biostudies-literature | 2012 Jan

REPOSITORIES: biostudies-literature