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MedulloblastomaPhase 2NCT06701812

Digoxin Medulloblastoma Study

A Phase 2 study testing Digoxin in people with Medulloblastoma and Medulloblastoma, Non-WNT/Non-SHH, run by H. Lee Moffitt Cancer Center and Research Institute at 17 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 12 months to 30 years
What is being tested?
Digoxin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
17 sitesUnited States
Study dates
15 Jan 2026to Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 months to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients must be age >12 months and <30 years at the time of enrollment.
  • Patients must have relapsed non-WNT, non-SHH medulloblastoma confirmed by a CAP/CLIA certified assay (such as nanostring or methylation) performed on tissue from diagnosis or relapse.
  • Patients must have received at least one prior course of chemotherapy for their medulloblastoma. They must also have received irradiation.
  • Prior therapy: Therapy may not have been received more recently than the timeframes defined below: Craniospinal radiotherapy: At least 3 months have elapsed since prior craniospinal radiotherapy (at doses ≥ 18 Gy). Local radiotherapy: At least 3 months since prior local radiotherapy to primary tumor. Focal radiotherapy: At least 2 weeks since prior focal radiotherapy to symptomatic metastatic sites. Myelosuppressive chemotherapy and/or immunotherapy and/or biologics: More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas), immunotherapy, or biologics. Hematopoietic growth factor: Seven days must have elapsed since the completion of therapy with colony-stimulating factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or erythropoietin), or platelet-stimulating agents.
  • Patients must have recovered from any surgical procedures such as biopsy, with neurological stability for > 7 days.
  • Patients must have clear residual disease, defined as tumor that is measurable in two perpendicular diameters on MRI (ie, largest tumor diameter and its largest perpendicular). The size of a measurable lesion at baseline should be at least 2 times the thickness of the slices showing the tumor (adding the interslice gap).
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  • Patients must have a Lansky or Karnofsky performance status score of ≥ 50%. Use Karnofsky for patients > 16 years of age and Lansky for patients < 16 years of age. Patients who are unable to ambulate but who are functional in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.
  • Patients must have normal organ and marrow function.
  • Patient has no evidence of Wolff-Parkinson-White syndrome or high-grade AV block (form of second-degree heart block) on screening ECG.
  • Patient has no evidence of hypertrophic obstructive cardiomyopathy on screening echo.
  • Any patient that reports recent palpitations (within the last month), or concerning findings on echo or ECG must be evaluated and cleared for treatment with digoxin by a cardiologist prior to enrollment. Study PI should be contacted for additional questions/concerns regarding these patients.
  • Patients receiving concurrent dexamethasone are eligible, provided dosage is stable or decreasing for ≥7 days prior to study enrollment.
  • Patients must have a stable neurologic status for ≥7 days prior to study enrollment. If a patient experiences neurologic decline following enrollment but prior to day 1 of cycle 1, they should be reassessed for eligibility.
  • Pregnancy: Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment. Female patients who are lactating must agree to stop breastfeeding.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • All patients and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.

Who cannot join

  • Participants who are receiving concurrent anticancer or any other investigational agents are ineligible.
  • Participants taking digoxin for any reason during treatment for initial diagnosis of medulloblastoma or relapse are ineligible. Exposure to digoxin therapy prior to initial diagnosis of medulloblastoma is allowed.
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to digoxin are ineligible.
  • Patients with serious or inadequately controlled cardiac arrhythmias, including baseline ectopy, ventricular tachycardia, frequent premature ventricular contractions (PVCs), or symptomatic sinus bradycardia are excluded from the study.
  • Patients taking medications that are known to interfere with digoxin metabolism are ineligible.
  • Participants with uncontrolled intercurrent illness, concurrent clinically significant unrelated systemic illness (e.g. serious infection) or significant cardiac, pulmonary, hepatic, or other organ dysfunction that would compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results are ineligible.
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  • Participants with psychiatric illness/social situations that would limit compliance with study requirements are ineligible.
  • Pregnant women or women unwilling to stop breastfeeding are excluded from this study because it is unknown how pregnant women with recurrent medulloblastoma will metabolize and tolerate digoxin. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with digoxin in this setting.
  • Participants who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jessica Crimella contact

813-745-6250

Jessica.Crimella@moffitt.org

17 sites in 1 country

United States17 sites, 17 recruiting

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21218

    Kenneth Cohen, MD

    Recruiting

  • University of Alabama at Birmingham Children's of Alabama

    Birmingham, Alabama, 35233

    Laura Metrock, MD

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514

    David Kram, MD

    Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Erin Trovillion, MD

    Recruiting

  • UT Southwestern

    Dallas, Texas, 75390

    Matthew Campbell, MD

    Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

    Michael Isakoff, MD

    Recruiting

  • Nemours Jacksonville

    Jacksonville, Florida, 32207

    Darren Klawinski, MD

    Not yet recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    Tom Badgett, MD, PhD

    Recruiting

  • Arkansas Childrens Hospital

    Little Rock, Arkansas, 72202

    David Douglass, MD

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Bradley Gampel, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Scott Borinstein, MD

    Recruiting

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016

    Ross Mangum, MD

    Recruiting

  • Washington University St. Louis

    St Louis, Missouri, 63130

    Mohamed Abdelbaki, MD

    Recruiting

  • Johns Hopkins All Children's

    St. Petersburg, Florida, 33701

    Stacie Stapleton, MD

    Recruiting

  • St. Joseph's Children's Hospital

    Tampa, Florida, 33607

    Trisha Larkin, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Alice Lee, MD

    Recruiting

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    Eugene Hwang, MD

    Recruiting

Other trials in United States

About this study

Official title: Evaluation of Digoxin for Relapsed Non-WNT, Non-SHH Medulloblastoma

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.

Being tested
Digoxin
Medical subject headings
Medulloblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DigoxinDrug

    2.5-10 mcg/kg/day orally divided twice daily or once daily based on age on a continuous dosing schedule.

Study groups in NCT06701812
Study groupRoleWhat they receive
Digoxin TreatmentExperimentalDigoxin will be administered orally at a standard maintenance dosing. Each cycle will be 28 days.
Receives: Drug: Digoxin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival at 4 months (PFS4)

    Proportion of patients with progression free survival at 4 months after initiation of treatment.

    Measured: 4 months

Secondary outcomes (3)

  1. Response rate

    Response rate is defined as complete response (CR) + partial response (PR) at 4 months after initiation of study treatment.

    Measured: 4 months

  2. Stable Disease (SD)

    Stable disease rate as defined as stable disease (SD) at 4 months after initiation of study treatment.

    Measured: 4 months

  3. Event Free Survival

    Event Free Survival as defined as time from first dose of protocol therapy to secondary malignancy, death, or progression, whichever comes first.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2024
  2. Study start15 Jan 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06701812
Sponsor's protocol ID
MCC-23221
Status last verified
Aug 2026
First submitted
20 Nov 2024
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Digoxin in people with Medulloblastoma and Medulloblastoma, Non-WNT/Non-SHH, run by H. Lee Moffitt Cancer Center and Research Institute at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jessica Crimella (813-745-6250, Jessica.Crimella@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival at 4 months (PFS4) (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06701812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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