Low-grade Glioma Clinical Trial
Official title:
Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas
The purpose of this study is to investigate whether weekly Vinorelbine treatment can shrink
or slow the growth of pediatric low-grade gliomas that have either returned or are continuing
to grow.
Vinorelbine is a semi-synthetic vinca alkaloid that has recently generated interest in
patients with pediatric low-grade glioma. It has been specifically synthesized to broaden its
therapeutic spectrum and decrease the neurotoxicity associated with related agents.
Different treatments exist for children with progressive or recurrent low-grade glioma. Each
has variable efficacy at slowing or reversing growth, and exploration continues into finding
better-tolerated, more effective treatments.
Vinorelbine has recently generated interest in stabilizing some pediatric low-grade gliomas.
It has been fairly well tolerated in both adult and pediatric studies that have examined its
use in other tumors.
Objective: To test the efficacy of Vinorelbine in children with pediatric low-grade glioma
that has returned or continues to grow.
In this trial, Vinorelbine will be given intravenously once a week for 6 weeks followed by a
2 week rest (6 of every 8 weeks) for one year. The patients will then be followed for 60
months. Progression free survival is the primary outcome and defined as the none of the
following: greater a 20% increase in the sun of the longest diameter of the target lesion, or
a measurable increase in a non-target lesion, or the appearance of new lesions.
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