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| Diagnosis | Central nervous system (CNS) HR-EBT: Embryonal Tumor (various), Group 3 and 4 Medulloblastoma, Atypical Teratoid Rhabdoid Tumor, Pineoblastoma, CNS Neuroblastoma, Medulloepithelioma | Study Status | Open |
| Phase | I |
| Age | up to (and including) 6 Years old | Randomisation | NO |
| Line of treatment | First line treatment |
| Routes of Treatment Administration | Induction Phase:
- Drug: Double Therapy (Cytarabine, Hydrocortisone) - intrathecal (IT)
- Drug: Cisplatin - intravenous (IV)
- Drug: Vincristine - intravenous (IV)
- Drug: Etoposide - intravenous (IV)
- Drug: Cyclophosphamide - intravenous (IV)
- Drug: Mesna - intravenous (IV)
- Drug: Filgrastim - subcutaneous or intravenous (SC or IV)
Consolidation Phase:
- Drug: Carboplatin - intravenous (IV)
- Drug: Thiotepa - intravenous (IV)
- Drug: Filgrastim - subcutaneous or intravenous (SC or IV)
Maintenance Arms (A and/or B):
- Drug: Topotecan - intrathecal (IT)
- Drug (Maintenance A Only): Tamoxifen - oral (PO)
- Drug: ISOtretinoin - oral (PO)
- Drug (Maintenance B Only): Celecoxib - oral (PO)
- Drug (Maintenance B Only): Temozolomide - oral (PO)
- Drug (Maintenance B Only): Cyclophosphamide - oral (PO)
- Drug (Maintenance B Only): Etoposide - oral (PO) |
| Last Posted Update | 2026-01-22 |
| ClinicalTrials.gov # | NCT06942039 |
International Sponsor
C17 CouncilPrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Annie Huang
CHU Ste. Justine - Dr. Sébastien Perreault
Alberta Children's Hospital - Dr. Lucie Lafay-Cousin
BC Children's Hospital - Dr. George Michaiel
London Children's Hospital - Dr. Shayna ZelcerCentres
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. Alexandra Zorzi
Dr. Shayna Zelcer
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
Clinical research contact
Mariam Mikhail
Medical contact
Dr. Victor Lewis
Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Rebecca Deyell
Social worker/patient navigator contact
Ilana Katz
Clinical research contact
Hem/Onc/BMT Clinical Trials Unit
Study Description
A pilot study to see if it is possible and safe to add medicine given into the spinal fluid (intrathecal chemotherapy) and continued treatment (maintenance therapy) after strong chemotherapy for young children under 6 years old who have newly diagnosed high-risk brain tumors.
Inclusion Criteria
- Age: Children 6 years old or younger at the time their brain tumor is confirmed.
- Tumor types: Certain rare, aggressive brain or spinal tumors, including ATRT, medulloblastoma (group 3 or 4), pineoblastoma, ETMR, and other similar embryonal brain tumors.
- MRI scans: MRI of the brain and spine (with and without contrast) must be done before and after surgery.
- Lumbar puncture (spinal tap): A sample of spinal fluid is recommended (if safe to do) before or after surgery, but not required.
- Must meet all lab and organ function requirements
- Must be well enough to be up and about at least 50% of waking hours
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.
