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New treatment option for Medulloblastoma
Official title Digoxin Medulloblastoma Study
ClinicalTrials.gov ID: NCT06701812
What this study is testing
What is Digoxin?
Digoxin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for medulloblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 30
You may be able to join if
- 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...
- 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...
- Patients must have recovered from any surgical procedures such as biopsy, with neurological stability for \> 7 days.
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility criteria
- 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)...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- Participants who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Hartford, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 months to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Hartford, Connecticut, United States; Washington D.C., District of Columbia, United States; Jacksonville, Florida, United States; Miami, Florida, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.