Study on Digoxin for Treating Relapsed Medulloblastoma in Children and Young Adults

Inclusion Criteria

• Patients must be older than 12 months and younger than 30 years.
• Must have a confirmed diagnosis of relapsed non-WNT, non-SHH medulloblastoma.
• Must have received at least one previous chemotherapy treatment and radiation for their cancer.
• Must have completed certain treatments a specified time before joining the study, such as:
  • At least 3 months since craniospinal or local radiotherapy.
  • At least 2 weeks since focal radiotherapy to metastatic sites.
  • More than 3 weeks since chemotherapy, immunotherapy, or biologics.
  • At least 7 days since using growth factors or platelet-stimulating agents.
• Must have recovered from any surgeries and be neurologically stable for more than 7 days.
• Must have measurable tumor size on MRI scans.
• Must have a performance status score of 50% or higher, indicating they can perform daily activities.
• Must have normal organ and bone marrow function.
• Must not have certain heart conditions as shown on screening tests.
• Must be cleared by a cardiologist if there are any heart concerns.
• Can be on stable doses of dexamethasone.
• Must have a stable neurological condition for at least 7 days before joining.
• Females of childbearing age must have a negative pregnancy test and agree to stop breastfeeding.
• Must agree to use effective birth control during the study.
• Must be able to understand and sign a consent form, with help from parents or guardians if needed.

Exclusion Criteria

• Cannot be taking other cancer treatments or investigational drugs.
• Cannot have used digoxin during previous cancer treatments.
• Cannot have allergies to digoxin or similar drugs.
• Cannot have serious heart rhythm problems.
• Cannot be on medications that interfere with digoxin.
• Cannot have uncontrolled illnesses or organ dysfunction that would affect treatment.
• Cannot have psychiatric or social issues that would prevent following study requirements.
• Pregnant or breastfeeding women cannot participate.
• Cannot participate if unable to comply with study safety monitoring.