Actively Recruiting
Evaluation of Digoxin for Relapsed Non-WNT, Non-SHH Medulloblastoma in Pediatric and Young Adult Patients
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-27
23
Participants Needed
15
Research Sites
N/A
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
Researchers are evaluating the use of digoxin in treating pediatric and young adult patients with relapsed non-WNT, non-SHH medulloblastoma, a type of brain tumor. This phase 2 study aims to assess whether digoxin can improve progression-free survival and other outcomes in this specific group of patients who have already undergone chemotherapy and radiation treatment. Participants will receive digoxin orally in standard maintenance doses, divided once or twice daily based on age, with each treatment cycle lasting 28 days. The study focuses on continuous dosing, and the main treatment period is followed by monitoring for disease progression and response to therapy, including stable disease and event-free survival. During the study, participants will undergo regular assessments including MRI scans to measure tumor size and evaluation of organ and marrow function. Researchers will also monitor heart health through screening ECG and echocardiograms to check for conditions that may affect digoxin use. The primary outcome is progression-free survival at 4 months, with additional measures including response rate and event-free survival up to 12 months. Participants will be followed closely to track treatment effects and safety throughout the study duration.
CONDITIONS
Brief 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 received at least one prior chemotherapy course and irradiation for medulloblastoma.
- Prior therapies must meet specific waiting periods before enrollment, including at least 3 months since craniospinal or local radiotherapy, 2 weeks since focal radiotherapy to metastases, and 3 to 6 weeks since myelosuppressive therapies.
- Patients must have recovered from surgery with neurological stability for more than 7 days.
- Patients must have measurable residual tumor on MRI.
- Patients must have a Lansky or Karnofsky performance score of 50% or higher.
- Patients must have normal organ and marrow function.
- Patients must have no Wolff-Parkinson-White syndrome or high-grade AV block on ECG.
- Patients must have no hypertrophic obstructive cardiomyopathy on echocardiogram.
- Patients with recent palpitations or concerning heart findings must be cleared by a cardiologist.
- Patients can receive dexamethasone if dosage is stable or decreasing for 7 days.
- Patients must have stable neurologic status for 7 days prior to enrollment.
- Female patients of childbearing potential must have a negative pregnancy test and agree to contraception; lactating females must stop breastfeeding.
- Patients and/or guardians must understand and sign informed consent or assent.
You will not qualify if you...
- Participants receiving other anticancer or investigational agents are not eligible.
- Participants currently taking digoxin for medulloblastoma treatment are excluded.
- Patients with allergies to digoxin-related compounds are excluded.
- Patients with serious or uncontrolled cardiac arrhythmias or symptomatic bradycardia are not eligible.
- Patients taking medications that interfere with digoxin metabolism are excluded.
- Patients with uncontrolled or significant systemic illnesses that may affect treatment tolerance or study results are excluded.
- Patients with psychiatric or social conditions limiting compliance are excluded.
- Pregnant women or women unwilling to stop breastfeeding are excluded.
- Patients unlikely to comply with safety monitoring requirements are excluded.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants receive digoxin orally on a continuous dosing schedule with each cycle lasting 28 days.
Visits occur each cycle for treatment and monitoring
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
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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