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Phase II Study of Naxitamab Added to Induction Therapy for Subjects with Newly Diagnosed High-Risk Neuroblastoma

Objective

To evaluate the VGPR(+) rate (VGPR + CR rate) to naxitamab with standard induction therapy for subjects with newly-diagnosed high-risk neuroblastoma according to the 1993 International Neuroblastoma Response Criteria (INRC) and compare to relevant historical controls.

Protocol #

BCC018

Trial Phase:

Phase II

Principal Investigator:

Gowda, Madhu

Cancer Type
  • Brain and Nervous System
Study Site
  • Virginia Commonwealth University

Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.

Age > 18 months (> 547 days) regardless of biologic features or
ii. Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic features (MYCN amplification, unfavorable pathology and/or DNA index = 1) or
iii. MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features.
Subjects must be age </= 21 years at initial diagnosis
Subjects must be >12 months of age at enrollment

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Both
  • Protocol Type Treatment
  • Research Study Team Lindsey Gwaltney, MS, RN
    Phone: +1 804-628-2112
    Email Study Contact

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