DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma
Phase II Trial of Eflornithine/DFMO as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma
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Clinical Trial Information
Trial Contact: Spinelli, Jennifer; Armatti, Julie M; Doyle, Katherine M; Dubberly, Paige D; Parker, Melanie
Trial Phone: 321.841.5357 ; 321-843-5284 ; 3218412008 ; 321-841-7561 ; 321-843-1036
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IRB No: 22.164.08
Protocol Abbrev: BCC016
Principal Investigator: Amy A. Smith, MD
Phase: Drug: Phase II
Age Group: Pediatric
Secondary Protocol No: BCC016
Treatment: Drug: Eflornithine
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT04696029
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Objective
To evaluate the efficacy of difluoromethylornithine (DFMO) as a single agent in preventing
relapse in patients with molecular high risk and very high risk medulloblastoma, and
relapsed/refractory medulloblastoma based upon the 2-year progression-free survival rate
(PFS) compared to relevant historical controls. -
Key Eligibility
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.
