Vinblastine +/- Bevacizumab for treatment of pediatric LGG

• Research type

  Research Study

• Full title

  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).

• IRAS ID

  229140

• Contact name

  Eric Bouffet

• Contact email

  eric.bouffet@sickkids.ca

• Sponsor organisation

  The Hospital for Sick Children

• Eudract number

  2017-001982-26

• Clinicaltrials.gov Identifier

  NCT02840409

• Duration of Study in the UK

  8 years, 9 months, 3 days

• Research 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 than 18 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.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  18/LO/0325

• Date of REC Opinion

  26 Apr 2018

• REC opinion

  Further Information Favourable Opinion