DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma
ConditionMedulloblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorGiselle Sholler
About this trial
Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma.
Eligibility criteria
Qualifiers
Age: 0-21 years of age at diagnosis
Pathology All patients must either have a pathologically confirmed diagnosis of medulloblastoma with molecular grouping identified by either Nanostring or methylation profiling.
Metastatic non-MYC amplified Group 3
Metastatic Group 4
Disqualifiers
BSA of <0.25 m2
Metastatic disease outside of CNS
Relapsed/refractory patients who are radiation-naïve and age 5 years or older at time of enrollment
Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
Trial design
Treatments tested in this trial
- Difluoromethylornithine
Treatment groups
118 Participants
are divided into 1 treatment groupSponsors and collaborators
Giselle Sholler
Lead sponsor
Milton S. Hershey Medical Center
Sponsor institution
Source ClinicalTrials.gov