Actively Recruiting
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation
Led by C17 Council · Updated on 2026-02-27
15
Participants Needed
12
Research Sites
379 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pilot study to determine feasibility of adding intrathecal chemotherapy and maintenance therapy after high dose chemotherapy for treatment of newly diagnosed HR-EBTs in patients less than 6 years of age.
CONDITIONS
Official Title
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Tumor tissue sample available
- Age between 0 and 6 years at diagnosis
- Diagnosis of high-risk CNS embryonal brain tumors including ATRT, group 3 or 4 medulloblastoma, pineoblastoma, CNS neuroblastoma, ETMR (including ETANTR, ependymoblastoma), medulloepithelioma, CNS embryonal tumor with rhabdoid features, or CNS embryonal tumor not otherwise specified
- Baseline brain and spine MRI with and without contrast performed pre- and post-operatively
- Lumbar puncture for cerebrospinal fluid cytology recommended if medically feasible
- Life expectancy greater than 8 weeks from diagnosis
- Performance status with Lansky score of 50 or higher
- Normal organ and marrow function including adequate kidney, heart, lung, bone marrow, and liver function as defined by specific laboratory and clinical criteria
You will not qualify if you...
- Receiving other anti-cancer or investigational treatments
- Previous chemotherapy or radiotherapy for this tumor, except corticosteroids
- Presence of another active malignancy requiring treatment
- Use of certain medications affecting cytochrome P450 3A4 enzyme (e.g., enzyme-inducing anticonvulsants, certain antifungals, rifampin, St. John's wort)
- Severe or uncontrolled medical diseases including uncontrolled diabetes, chronic kidney or liver disease, active infection, heart failure, unstable angina, arrhythmia, hyperparathyroidism, or psychiatric/social issues limiting compliance
- Known HIV infection or hepatitis B or C
- Tumor types not eligible such as sonic hedgehog and wingless medulloblastomas, ependymomas, choroid plexus carcinomas, high-grade glial tumors, diffuse midline gliomas, CNS germ cell tumors, CNS sarcomas, CNS lymphomas, or leukemic lesions
- Inability of participant or guardians to adhere to study schedule and protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Alberta Children's Hospital
Calgary, Alberta, Canada
Actively Recruiting
2
BC Children's Hospital
Vancouver, British Columbia, Canada
Actively Recruiting
3
CancerCare Manitoba (CCMB)
Winnipeg, Manitoba, Canada
Not Yet Recruiting
4
IWK Health Centre
Halifax, Nova Scotia, Canada
Not Yet Recruiting
5
McMaster Children's Hospital
Hamilton, Ontario, Canada
Not Yet Recruiting
6
London Health Sciences Centre
London, Ontario, Canada
Actively Recruiting
7
CHU Sainte-Justine
Montreal, Quebec, Canada
Actively Recruiting
8
Montreal Children's Hospital (McGill)
Montreal, Quebec, Canada
Not Yet Recruiting
9
CHU de Québec-Université Laval
Québec, Quebec, Canada
Not Yet Recruiting
10
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada
Not Yet Recruiting
11
Stollery Children's Hospital
Edmonton, Canada
Not Yet Recruiting
12
The Hospital for Sick Children
Toronto, Canada
Actively Recruiting
Research Team
S
Sylvia Cheng
CONTACT
C
C17 Council
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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