Vinorelbine for 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas|
- Progression-free survival [ Time Frame: 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. ] [ Designated as safety issue: No ]
- Quality of life assessments [ Time Frame: Assessed yearly for the 60 months. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Drug: Weekly vinorelbine treatment
Vinorelbine will be administered IV once a week for 6 out of every 8 weeks. This will continue barring progression or unacceptable toxicity for at least one year.
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 being treated.
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 benefit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497860
|Contact: Eugene Hwang, MDfirstname.lastname@example.org|
|Contact: Alissa Munemail@example.com|
|United States, District of Columbia|
|Children's National Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Eugene Hwang, MD 202-476-5046 firstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Amulya Rao, MBBS 507-284-2652 NageswaraRao.Amulya@mayo.edu|
|Principal Investigator: Amulya Rao, MBBS|
|Principal Investigator:||Eugene Hwang, MD||Children's Research Institute|