CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Vinorelbinedrug
Likely dose
Vinorelbine 6mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01497860
NCT01497860Phase 2Completed
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Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas

Eugene Hwang·interventional·Posted Dec 23, 2011·Updated May 20, 2019

In Brief

A Phase 2 clinical trial evaluating Vinorelbine for Low-grade Glioma. Completed, enrolled 13 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow-grade Glioma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 23, 2011
Enrollment StartJul 1, 2011
Primary CompletionJan 1, 2017
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 14.5 years ago

Interventions

Vinorelbinedrug

IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.