Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-30 @ 7:24 PM
Study NCT ID:
NCT01497860
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2011-12-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas
Sponsor:
Eugene Hwang
Organization:
Study Overview
Official Title:
Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: