Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas
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.
In addition, the quality of life for children with low-grade gliomas is important and
requires further study. This trial will incorporate an optional assessment using validated
neuropsychological testing throughout treatment to evaluate the quality of life of the child
Objective: To test the efficacy of Vinorelbine in a larger number of 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. This cycle can then be repeated for up to 1-2 years if providing clinical
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or date off study. This will be assessed continually for 60 months.
Eugene Hwang, MD
Children's Research Institute
United States: Institutional Review Board
|Mayo Clinic||Rochester, Minnesota 55905|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|