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Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

  • Clinical Trial Information

    Trial Contact: Cevallos, Claudia; El-Shami, Jessica; Leffin, Melissa; Spinelli, Jennifer

  • IRB No: 20.100.06

    Protocol Abbrev: BCC015

    Principal Investigator: Alejandro Gustavo Levy, MD

    Phase: Drug: Phase II

    Age Group: Pediatric

    Secondary Protocol No: BCC015

    Treatment: Drug: Eflornithine

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT04301843

  • Objective

    To evaluate the efficacy of difluoromethylornithine (DFMO) in combination with etoposide in patients with relapsed/refractory neuroblastoma, based upon event free survival (EFS) from time of enrollment.

  • Key Eligibility

    •  All patients must have a pathologically confirmed diagnosis of neuroblastoma, ≤ 30.99 years of age with history of relapsed/refractory neuroblastoma.
    •  All patients must have completed upfront therapy with at least 4 cycles of aggressive multi-drug chemotherapy.
    •  Timing from prior therapy: Enrollment (first dose of DFMO) no later than 60 days from last dose of the most recent therapy.

    •  Subjects must have fully recovered from the acute toxic effects of all prior anti- cancer chemotherapy and be within the following timelines:
    1.Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea).
    2.Hematopoietic growth factors: At least 5 days since the completion of therapy with a growth factor.
    3.Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Study Chair.
    4.Immunotherapy: At least 6 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines, CAR-T cells.
    5.Anti-GD2 Monoclonal antibodies: At least 2 weeks must have elapsed since prior treatment with a monoclonal antibody.
    6.XRT: At least 14 days since the last treatment except for radiation delivered with palliative intent to a non-target site.
    7.Stem Cell Transplant:
    a.Allogeneic: No evidence of active graft vs. host disease
    b.Allo/Auto: ≥ 2 months must have elapsed since transplant.
    8.MIBG Therapy: At least 8 weeks since treatment with MIBG therapy
    •  Subjects must have a Lansky or Karnofsky Performance Scale score of 60% or higher.
    •  Life expectancy > 2 months
    •  All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to first dose of study drug unless otherwise indicated below.
    •  Subjects must have adequate organ functions at the time of registration:
    ◦Hematological: Total absolute neutrophil count ANC ≥750/μL
    ◦Liver: Subjects must have adequate liver function as defined by AST and ALT <5x upper limit of normal (Normal=45), Bilirubin <1.5x upper limit normal (Normal=1.0). Normal PT, PTT, fibrinogen.
    ◦Renal: Adequate renal function defined as (perform one of the following): Creatinine clearance or radioisotope GFR 70 mL/min/1.73 m2 or greater or a serum creatinine based on age/gender
    •  Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.