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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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Title
Status

 

CONNECT1905 - Phase 2 Study of Systemic IL-6 Receptor Antagonist ACTEMRA® (Tocilizumab) for the Treatment of Progressive/Recurrent Pediatric Adamantinomatous Craniopharyngioma

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CONNECT1905 - Phase 2 Study of Systemic IL-6 Receptor Antagonist ACTEMRA® (Tocilizumab) for the Treatment of Progressive/Recurrent Pediatric Adamantinomatous Craniopharyngioma

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DiagnosisAdamantinomatous Craniopharyngioma, Recurrent Adamantinomatous CraniopharyngiomaStudy StatusOpen
PhaseII
Age1 Year to 25 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Tocilizumab (Route: IV)
Last Posted Update2025-06-18
ClinicalTrials.gov #NCT05233397
International Sponsor
Sponsor:
Nationwide Children's Hospital

Collaborator:
Children's Hospital Colorado
Principal Investigators for Canadian Sites
The Hospital for Sick Children (SickKids): Dr. Julie Bennett
Montreal Children's Hospital: Dr. Geneviève Legault
Stollery Children's Hospital: Dr. Liana Nobre
Centres
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
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

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

 

 

Study Description

In this study, a drug called tocilizumab will be used to treat patients with a brain tumour called Adamantinomatous Craniopharyngioma between the ages of 1 and 25 years old. This cancer is currently treated with surgery and radiation, which can impact the quality of life for patients - instead, this drug interacts with IL-6, which is a type of protein in your body called a cytokine. By blocking the function of IL-6, this study explores if the drug is safe and effective at inducing a tumor response.

Inclusion Criteria
  • Participants must be ≥ 12 months and ≤ 25 years of age at the time of study enrollment.
  • Participants must have a confirmed diagnosis of adamantinomatous craniopharyngioma that has previously been treated
  • Participants must be up and about at least half of their waking hours
  • Must have recovered from the effects of any prior therapies
  • Participants must meet the organ function and lab work requirements 
  • Participants and/or their parents or legal authorized representatives must sign a written informed consent.

 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.