Canadian clinical trial registry

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1 results found

Title
Status

 

OZM-063 - 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)

Closed to enrollment

OZM-063 - 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)

Go to Health Care Provider version

DiagnosisLow Grade GliomaStudy StatusClosed to enrollment
PhaseII
AgeChild, Adult - (6 Months to 18 Years)RandomisationYES
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment Administrationintravenous
Last Posted Update2024-01-08
ClinicalTrials.gov #NCT02840409
International Sponsor
The Hospital for Sick Children / Hoffmann-La Roche
Principal Investigators for Canadian Sites
Montreal Children’s Hospital – Dr. Geneviève Legault
The Hospital for Sick Children – Dr. Uri Tabori
Alberta Children’s – Dr. Lucie Lafay-Cousin
BC Children’s Hospital – Dr. Juliette Hukin
CHU Ste-Justine – Dr. Yvan Samson
Stollery Children’s Hospital – Dr. Bev Wilson
CHU de Quebec - Dr. Valerie Larouche
CancerCare Manitoba - Dr. Issai Vanan
Children’s Hospital of Eastern Ontario (CHEO) - Dr. Donna L. Johnston
Hamilton Health Sciences Centre - Dr. Uma Athale
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Carol Duchenne
 
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 

 

 

Study Description

This study is trying to determine the benefit of adding bevacizumab (an intravenous drug) to chemotherapy treatment with vinblastine, in children and adolescents with low grade gliomas.

Participants in this trial will be randomised (randomly assigned) into one of two treatment arms.

  • Arm A will include 68 weeks (16 months) of single agent Vinblastine given once weekly intravenously.
  • Arm B will include 68 weeks (16 months) of Vinblastine given weekly intravenously with the addition of 12 doses of bevacizumab given every two weeks intravenously for the initial 24 weeks (6 months).
Inclusion Criteria
  • Children and adolescents aged 6 months to < 18 years
  • Low grade glioma 
  • The tumour must have grown back after surgery with clear imaging or clinical signs, or
  • The tumour was partially removed with surgery and there is a necessity to begin treatment because of a risk of neurological impairment with progression.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team