DFMO in Combo w/ Bortezomib for Relapsed or Refract Neuroblastoma

Phs I/II DFMO combo w/Brtezmib in pts w/Relpsd or Refrct Nrblstma

November 22, 2017

  • Clinical Trial Information

    Trial Contact: El-Shami, Jessica; Francois, Laetitia Claire; Leffin, Melissa; Spinelli, Jennifer

  • IRB No: 14.115.09

    Protocol Abbrev: NMTRC-010B

    Principal Investigator: Don E. Eslin, MD

    Sub Investigators: Giusti, Vincent MD; Smith, Amy MD; Sutphin, Robert MD; Levy, Alejandro MD; Pope, Michele ARNP; Story, Allison ARNP; Sullivan Darden, Kelly ARNP; Wieber, Laura ARNP

    Phase: Drug: Phase I

    Age Group: Pediatric

    Secondary Protocol No: NMTRC-010B

    Treatment: Drug: DFMO Drug: Bortezomib

    Applicable Disease Sites: Neuroblastoma

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT02139397

  • Objective

    The purpose of this research study is to evaluate an investigational drug (DFMO) in combination with bortezomib, for relapsed and refractory neuroblastoma. DFMO is an investigational drug because it has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the safety and tolerability of DFMO in combination with bortezomib as well as the tumors response to this study drug.

  • Key Eligibility

    Ages Eligible for Study: up to 21 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No