Actively Recruiting
Digoxin Medulloblastoma Study
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-27
23
Participants Needed
15
Research Sites
54 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
N
National Pediatric Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Digoxin Medulloblastoma Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be older than 12 months and younger than 30 years at enrollment.
- Patients must have relapsed non-WNT, non-SHH medulloblastoma confirmed by a certified assay.
- Patients must have had at least one prior chemotherapy course and irradiation for medulloblastoma.
- At least 3 months must have passed since prior craniospinal or local radiotherapy; at least 2 weeks since focal radiotherapy to metastatic sites.
- More than 3 weeks since prior myelosuppressive chemotherapy, immunotherapy, or biologics; 7 days since colony-stimulating factor therapy.
- Patients must have recovered from surgery with neurological stability for over 7 days.
- Patients must have measurable residual tumor on MRI.
- Patients must have a Lansky or Karnofsky performance status score of 50% or higher.
- Patients must have normal organ and marrow function.
- No evidence of Wolff-Parkinson-White syndrome or high-grade AV block on ECG.
- No evidence of hypertrophic obstructive cardiomyopathy on echocardiogram.
- Any recent palpitations or concerning heart findings must be cleared by a cardiologist.
- Patients on dexamethasone are eligible if dosage is stable or decreasing for at least 7 days.
- Neurologic status must be stable for at least 7 days before enrollment.
- Females of childbearing potential must have a negative pregnancy test and agree to stop breastfeeding.
- Women and men must agree to use effective contraception during the study.
- Patients and/or guardians must understand and agree to informed consent or assent.
You will not qualify if you...
- Patients receiving other anticancer or investigational agents concurrently.
- Patients taking digoxin currently for medulloblastoma treatment.
- History of allergic reactions to digoxin or similar compounds.
- Serious or uncontrolled cardiac arrhythmias, frequent premature ventricular contractions, or symptomatic sinus bradycardia.
- Use of medications interfering with digoxin metabolism.
- Uncontrolled illness or significant organ dysfunction that would affect treatment tolerance or study participation.
- Psychiatric or social issues limiting compliance with study requirements.
- Pregnant women or women unwilling to stop breastfeeding.
- Patients unable to comply with safety monitoring requirements as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
University of Alabama at Birmingham Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Arkansas Childrens Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Not Yet Recruiting
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
5
Nemours Jacksonville
Jacksonville, Florida, United States, 32207
Not Yet Recruiting
6
University of Miami
Miami, Florida, United States, 33136
Not Yet Recruiting
7
Johns Hopkins All Children's
St. Petersburg, Florida, United States, 33701
Not Yet Recruiting
8
St. Joseph's Children's Hospital
Tampa, Florida, United States, 33607
Actively Recruiting
9
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21218
Actively Recruiting
10
Washington University St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
11
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
12
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
13
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
14
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
15
UT Southwestern
Dallas, Texas, United States, 75390
Not Yet Recruiting
Research Team
J
Jessica Crimella
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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