Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01497860
Study type Interventional
Source Children's Research Institute
Contact
Status Completed
Phase Phase 2
Start date July 2011
Completion date July 2017

See also
  Status Clinical Trial Phase
Recruiting NCT04734444 - SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue N/A
Recruiting NCT01837862 - A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas Phase 1/Phase 2
Recruiting NCT06104488 - A Study of Avutometinib for People With Solid Tumor Cancers Phase 1
Completed NCT04659421 - Study of Recombinant Human Endostatin Combined With CV Regimen in the Treatment of Pediatric Low-grade Gliomas Phase 2
Recruiting NCT04174820 - Child's Study of the Impact of PF Lesion on Motor Skills, Language, Cognitive Functioning and Social Cognition
Completed NCT02197637 - Phase II Trial of Oral Vinorelbine in Children With Recurrent or Progressive Unresectable Low-Grade Glioma Phase 2
Completed NCT05373394 - Evaluation of Cognitive and Motor Neurological Disorders in the Short and Long Term After Surgery for the Removal of a Diffuse Low-grade Glioma of the Supplementary Motor Area
Recruiting NCT05406700 - Niraparib In Recurrent IDH 1/2 Gliomas Early Phase 1
Active, not recruiting NCT04865315 - A Living Tissue Bank of Patient-Derived Organoids From Glioma Tumors
Recruiting NCT06159478 - Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume) Phase 2
Recruiting NCT06381570 - Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas Early Phase 1
Terminated NCT03763422 - Trial in Low Grade Glioma Patients: Wait or Treat Phase 3
Completed NCT04346472 - Longitudinal MRI Assessment in Patients With Diffuse Low-grade Gliomas
Active, not recruiting NCT03948490 - Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas N/A
Recruiting NCT04923126 - SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma Phase 1/Phase 2
Completed NCT00782626 - Everolimus (RAD001) for Children With Chemotherapy-Refractory Progressive or Recurrent Low-Grade Gliomas Phase 2
Completed NCT05873946 - Assessing the Effectiveness of 2D Non-Navigated Intraoperative Ultrasound in Glioma Surgery
Not yet recruiting NCT05555550 - Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG Early Phase 1
Withdrawn NCT05233215 - GROW (Glioma Specialists Reaching Out With Support) Support N/A
Recruiting NCT05566795 - DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) Phase 3