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Cardiac Glycoside
Digoxin for Medulloblastoma
Phase 2
Waitlist Available
Led By Laura Metrock, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have specific timeframes since prior therapy: craniospinal radiotherapy (≥18 Gy): at least 3 months, local radiotherapy to primary tumor: at least 3 months, focal radiotherapy to symptomatic metastatic sites: at least 2 weeks, myelosuppressive chemotherapy and/or immunotherapy and/or biologics: more than 3 weeks (6 weeks for nitrosoureas), hematopoietic growth factor: 7 days
Patients must have clear residual disease measurable on MRI
Must not have
Participants receiving concurrent anticancer or investigational agents are ineligible
Patients with serious or inadequately controlled cardiac arrhythmias are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if digoxin is effective in treating a specific type of brain tumor that has come back in children and young adults."
Who is the study for?
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.
What is being tested?
The study tests the effectiveness of digoxin in treating specific types of medulloblastoma that have returned after previous treatments. It focuses on patients who do not respond to standard therapies for this brain tumor affecting children and young adults.
What are the potential side effects?
Potential side effects from digoxin may include nausea, vomiting, dizziness, fatigue, visual changes (like blurred or yellow vision), confusion or mental changes. Serious side effects could involve heart problems such as irregular heartbeat.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My MRI shows clear signs of remaining disease.
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I can do most of my daily activities by myself.
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I am between 1 year and 30 years old.
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My organs and bone marrow are functioning normally.
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My neurological condition has been stable for at least 7 days.
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I am not pregnant, will take a pregnancy test, and agree to stop breastfeeding.
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My medulloblastoma is not WNT or SHH type, confirmed by a specific test.
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I have had chemotherapy and radiation for my medulloblastoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently taking any cancer treatments or experimental drugs.
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I do not have serious or uncontrolled heart rhythm problems.
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I do not have any uncontrolled illnesses or major organ problems.
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I am not taking digoxin for any condition while being treated for medulloblastoma.
Select...
I am not on medications that affect digoxin metabolism.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival at 4 months (PFS4)
Secondary study objectives
Event Free Survival
Response rate
Stable Disease (SD)
Side effects data
From 2018 Phase 4 trial • 178 Patients • NCT031360682%
hemmorhage
1%
pregnancy labor
1%
fever
1%
cramping
1%
severe nausea
1%
vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Digoxin
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Digoxin TreatmentExperimental Treatment1 Intervention
Digoxin will be administered orally at a standard maintenance dosing. Each cycle will be 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digoxin
2017
Completed Phase 4
~670
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
564 Previous Clinical Trials
144,860 Total Patients Enrolled
National Pediatric Cancer FoundationOTHER
7 Previous Clinical Trials
268 Total Patients Enrolled
Laura Metrock, MDPrincipal InvestigatorUniversity of Alabama at Birmingham Children's of Alabama
Jonathan Metts, MDStudy ChairMoffitt Cancer Center
4 Previous Clinical Trials
117 Total Patients Enrolled