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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

  • Clinical Trial Information

    Trial Contact: Doyle, Katherine M; Dubberly, Paige D; Parker, Melanie; Armatti, Julie M; Frankos, Marie

  • IRB No: 22.164.08

    Protocol Abbrev: BCC016

    Principal Investigator:

    Phase: Drug: Phase II

    Age Group: Pediatric

    Secondary Protocol No: BCC016

    Treatment: Drug: Eflornithine

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT04696029

  • 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.