Digoxin for Medulloblastoma
Trial Summary
Do I need to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot take medications that interfere with digoxin metabolism or any other investigational agents. It's best to discuss your current medications with the study team.
Is digoxin generally safe for humans?
Digoxin has been associated with increased risks of certain cancers, such as breast and uterus cancer, and there is a higher risk of toxicity, especially in women. However, its safety has improved over the years, and studies suggest it may be safe for some cancer patients after adjusting for other factors.12345
How is the drug digoxin unique in treating medulloblastoma?
What is the purpose of this trial?
The purpose of this study is to evaluate the efficacy of digoxin in treating relapsed non-SHH, non-WNT medulloblastoma in pediatric and young adult patients.
Research Team
Jonathan Metts, MD
Principal Investigator
Moffitt Cancer Center
Laura Metrock, MD
Principal Investigator
University of Alabama at Birmingham Children's of Alabama
Eligibility Criteria
This trial is for pediatric and young adult patients aged >12 months and <30 years with relapsed non-SHH, non-WNT medulloblastoma. They must have measurable disease on MRI, stable neurological status, specific cardiac criteria met, normal organ/marrow function, and a performance score of ≥50%. Prior chemotherapy and irradiation are required. Contraception use is necessary for those who can bear children.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Digoxin will be administered orally at a standard maintenance dosing. Each cycle will be 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Digoxin
Digoxin is already approved in European Union, United States, Canada, Japan for the following indications:
- Atrial fibrillation
- Atrial flutter
- Supraventricular tachycardia
- Congestive heart failure
- Atrial fibrillation
- Atrial flutter
- Supraventricular tachycardia
- Congestive heart failure
- Atrial fibrillation
- Atrial flutter
- Supraventricular tachycardia
- Congestive heart failure
- Atrial fibrillation
- Atrial flutter
- Supraventricular tachycardia
- Congestive heart failure
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
National Pediatric Cancer Foundation
Collaborator