Arsenic trioxide added to chemotherapy for children whose medulloblastoma came back
Official title: Arsenic Trioxide Combined With Chemotherapy for Relapsed SHH-Activated and/or TP53-Mutant Medulloblastoma
Status: Not yet recruiting. It has not opened yet. Ask your care team to watch for it if it looks like a fit.
The trial team last updated this record on .
The short version
This study tests a drug called arsenic trioxide, added to chemotherapy, in children whose brain tumor came back.
Read our full plain-language summary
What the trial team says
This prospective, open-label, single-arm, multicenter study will evaluate the efficacy and safety of arsenic trioxide (ATO) combined with chemotherapy in pediatric patients with relapsed or refractory SHH-activated medulloblastoma and/or TP53-mutant medulloblastoma. Eligible participants will be 18 months to 18 years of age. Participants will receive six cycles of induction chemotherapy containing ATO in combination with etoposide and either cisplatin or cyclophosphamide. The primary outcome is the objective response rate (ORR), defined as the proportion of participants achieving a complete response or partial response, assessed according to the Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria by an independent review committee. Secondary outcomes include overall survival, progression-free survival, and treatment-related safety, including adverse events and serious adverse events. A total of 78 participants are planned for enrollment.
Key facts
- Registry number
- NCT07856069
- Stage of testing
- Phase 2
- Conditions studied
- Medulloblastoma
Where it is running
This trial lists 1 site.
-
Guangdong
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Guangzhou)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.