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Clinical Trial Summary

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.


Clinical Trial Description

In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 2500 mg/m2 BID on each day of study. Subjects will be evaluated in 3 Cohorts: Cohort 1: Molecular High Risk Medulloblastoma Cohort 2: Molecular Very High Risk Medulloblastoma Cohort 3: Relapsed/Refractory Medulloblastoma A total of 118 subjects across all cohorts will be enrolled to ensure that there will be 107 evaluable subjects (32-39 per cohort) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04696029
Study type Interventional
Source Milton S. Hershey Medical Center
Contact Genevieve Bergendahl, MSN
Phone 7175310003
Email gbergendahl@pennstatehealth.psu.edu
Status Recruiting
Phase Phase 2
Start date March 29, 2021
Completion date March 2029

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