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| Diagnosis | Adamantinomatous Craniopharyngioma, Recurrent Adamantinomatous Craniopharyngioma | Study Status | Open |
| Phase | II |
| Age | 1 Year to 25 Years | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Drug: Tocilizumab (Route: IV) |
| Last Posted Update | 2024-07-09 |
| ClinicalTrials.gov # | NCT05233397 |
International Sponsor
Sponsor:
Nationwide Children's Hospital
Collaborator:
Children's Hospital ColoradoPrincipal Investigators for Canadian Sites
The Hospital for Sick Children (SickKids):
Montreal Children's Hospital: Dr. Geneviève LegaultCentres
Medical contact
Clinical Research Unit
Social worker/patient navigator contact
Clinical Research Unit
Clinical research contact
Stephanie Badour
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.
