Clinical Trial

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

Active, Not Recruiting Phase 2
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Record status
This record was last updated January 31, 2024 (before its estimated July 31, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2016-07-18; most recent amendment 2024-01-29.
Status change: Recruiting → Active, Not Recruiting 2024-01-29
Status change: Not Yet Recruiting → Recruiting 2016-12-23
Trial Details
NCT Number NCT02840409
Lead Sponsor The Hospital for Sick Children
Collaborators: Hoffmann-La Roche
Conditions Low Grade Glioma
Enrollment 109 participants
Start Date 2016-08-01
Primary Completion 2024-07-31 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2024-01-31