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Title
Status

 

DECRYPT-BABYBRAIN - A Pilot Study of Intrathecal Topotecan and Maintenance Chemotherapy in the Post-consolidation Setting for the Treatment of High-risk Embryonal Central Nervous System Tumours in Children Less Than 6 Years of Age

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DECRYPT-BABYBRAIN - A Pilot Study of Intrathecal Topotecan and Maintenance Chemotherapy in the Post-consolidation Setting for the Treatment of High-risk Embryonal Central Nervous System Tumours in Children Less Than 6 Years of Age

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DiagnosisCentral nervous system (CNS) HR-EBT: Embryonal Tumor (various), Group 3 and 4 Medulloblastoma, Atypical Teratoid Rhabdoid Tumor, Pineoblastoma, CNS Neuroblastoma, MedulloepitheliomaStudy StatusOpen
PhaseI
Ageup to (and including) 6 Years oldRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationInduction 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 Update2025-10-22
ClinicalTrials.gov #NCT06942039
International Sponsor
C17 Council
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Annie Huang
CHU Ste. Justine - Dr. Sébastien Perreault
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
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
 

 

 

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.