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Brief Title: DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma
Official Title: Phase II Trial of Eflornithine/DFMO as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma
Study ID: NCT04696029
Brief 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.
Detailed 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)
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Arkansas Children's Hospital, Little Rock, Arkansas, United States
UCSF Benioff Children's Hospital Oakland-, Oakland, California, United States
Rady Children's Hospital, San Diego, California, United States
Connecticut Children's Hospital, Hartford, Connecticut, United States
Arnold Palmer Hospital for Children, Orlando, Florida, United States
St. Joseph's Children's Hospital, Tampa, Florida, United States
Kentucky Children's Hospital, Lexington, Kentucky, United States
University of Louisville/Norton's Children's, Louisville, Kentucky, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
Cardinal Glennon Children's Medical Center, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Levine Children's Hospital, Charlotte, North Carolina, United States
Penn State Milton S. Hershey Medical Center and Children's Hospital, Hershey, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Dell Children's Blood and Cancer Center, Austin, Texas, United States
Name: Michael A Huang, MD
Affiliation: Beat Childhood Cancer at Atrium Health
Role: STUDY_CHAIR