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 groupLocations
24Canada
CHUQQC G1V 4W6, QuébecQuebec, Canada
United States
Arkansas
Arkansas Children's Hospital72202, Little Rock United States
California
UCSF Benioff Children's Hospital Oakland94609, Oakland United States
Rady Children's Hospital92123, San Diego United States
Sponsors and collaborators
Giselle Sholler
Lead sponsor
Milton S. Hershey Medical Center
Sponsor institution
Source ClinicalTrials.gov