NCT02840409

Vinblastine +/- Bevacizumab in Children With Unresectable or Progressive Low Grade Glioma (LGG)

A Phase II, Open-Labeled, Multi-Center, Randomized Controlled Trial of Vinblastine +/- Bevacizumab for the Treatment of Chemotherapy-Naïve Children With Unresectable or Progressive Low Grade Glioma (LGG)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized, multi-center, comparator Phase II trial looking at the addition of Bevacizumab to Vinblastine in chemotherapy naïve pediatric patients with progressive Low Grade Glioma aged 6 months to less than18 years of age at the time of initiation of therapy. Participants will be randomized to Arm A or Arm B. Arm A includes 68 weeks of single agent Vinblastine administered once weekly IV. Arm B includes 68 weeks of Vinblastine administered weekly IV with the addition of 12 doses of Bevacizumab administered every two weeks IV for the initial 24 weeks. Randomization will take place at the time of registration taking into account NF1 and BRAF-KIAA1549-fusion status.

Conditions

• Low Grade Glioma

Interventions

Type	Name	Description
DRUG	Vinblastine
DRUG	Bevacizumab

Timeline

• Start date: 2016-08-01
• Primary completion: 2024-07-31
• Completion: 2026-08-01
• First posted: 2016-07-21
• Last updated: 2024-01-31

Locations

21 sites across 4 countries: United States, Australia, Canada, New Zealand