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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
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BCC016 - Phase II Trial of Eflornithine/DFMO as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma

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BCC016 - Phase II Trial of Eflornithine/DFMO as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma

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DiagnosisMedulloblastomaStudy StatusOpen
PhaseII
Ageup to 21 YearsRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: Difluoromethylornithine (Oral) Other Names: Eflornithine, DFMO
Last Posted Update2025-12-04
ClinicalTrials.gov #NCT04696029
International Sponsor
Giselle Sholler
Principal Investigators for Canadian Sites
CHU Quebec - Dr. Bruno Michon
Centres
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

 

 

Study Description

Participants with a diagnosis of a brain tumour called medulloblastoma (categorized as high risk/very high risk or has not responded to previous treatment) will receive an oral dose of a medication called difluoromethylornithine (DFMO) twice a day while on study. 

Inclusion Criteria
  • Must be 21 years old or younger to participate
  • Have a confirmed diagnosis of medulloblastoma that has been categorized as high risk/very high risk or has not responded to previous treatment
  • A disease assessment that includes imaging, lumbar puncture (only if previously positive) and bone marrow aspiration biopsy (only if previously positive) will be done
  • Must have had enough time pass from any prior therapy (60 days from last dose of conventional chemotherapy and 45 days for high dose chemotherapy + stem cell transplantation)
  • Participants must be up and about for at least 50% of waking hours
  • Must meet all requirements for organ function, clinical and laboratory tests
  • Females of childbearing potential must have a negative pregnancy test and must agree to use an effective birth control method.
  • Participants or their legal representatives must sign an informed consent 

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