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Irinotecan, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma

A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma

  • Clinical Trial Information

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

  • IRB No: ANBL1821

    Protocol Abbrev: ANBL1821

    Principal Investigator: Amy A Smith, MD

    Phase: Drug: Phase II

    Age Group: Pediatric

    Secondary Protocol No: ANBL1821

    Treatment: Biological: Dinutuximab Drug: Eflornithine Drug: Irinotecan Biological: Sargramostim Drug: Temozolomide

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT03794349

  • Objective

    To determine whether administration of eflornithine (DFMO) in combination with dinutuximab, irinotecan hydrochloride (irinotecan) and temozolomide results in an improved response rate compared to dinutuximab, irinotecan and temozolomide in patients with relapsed or refractory neuroblastoma and therefore is a therapeutic regimen worthy of further testing in patients with newly-diagnosed high-risk neuroblastoma.

  • Key Eligibility

    Ages Eligible for Study: 1 Year and older (Child, Adult, Older Adult)
    Sexes Eligible for Study: All
    Accepts Healthy Volunteers: No

    •  Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines (i.e. > 2 x upper limit of normal [ULN]), at the time of initial diagnosis.