Study of Digoxin Treatment for Relapsed Non-WNT, Non-SHH Medulloblastoma in Children and Young Adults Aged 1 to 30 Years

What this Trial Is About

Researchers are evaluating the use of digoxin to treat relapsed non-SHH, non-WNT medulloblastoma in children and young adults aged over 12 months and under 30 years. This phase 2 trial aims to assess the effectiveness of digoxin in this specific type of brain tumor that has returned after prior treatments, providing important data on progression-free survival and disease response. Participants will receive oral digoxin at a maintenance dose ranging from 2.5 to 10 mcgkg per day, divided into once or twice daily doses, in repeated 28-day treatment cycles. This study includes only a single treatment group where all participants receive digoxin continuously, and the treatment schedule is designed to monitor response and side effects over time. During the study, participants will undergo regular evaluations including MRI scans to measure tumor size, performance status assessments, and cardiac monitoring such as ECG and echocardiograms to ensure safety. The main outcome measured is progression-free survival at 4 months, with additional assessments of response rates, stable disease status, and event-free survival up to 12 months. Participants will be closely monitored for neurological status and organ function throughout the trial, which is expected to continue until February 2027.

Digoxin Medulloblastoma Study