Digoxin Medulloblastoma Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-30
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Digoxin
Drug2.5-10 mcg/kg/day orally divided twice daily or once daily based on age on a continuous dosing schedule.
Treatment groups
23 Participants
are divided into 1 treatment groupGroup A: Digoxin TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression Free Survival at 4 months (PFS4)
Proportion of patients with progression free survival at 4 months after initiation of treatment.
Time frame
4 monthsSecondary outcomes
1
Response rate
Response rate is defined as complete response (CR) + partial response (PR) at 4 months after initiation of study treatment.
Time frame
4 months2
Stable Disease (SD)
Stable disease rate as defined as stable disease (SD) at 4 months after initiation of study treatment.
Time frame
4 months3
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.
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
National Pediatric Cancer Foundation
Collaborator
Source ClinicalTrials.gov