MedTrace Logo

131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases

NCT03275402 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-02-13

Study results available
· View outcomes & findings →

Summary

Children with a neuroblastoma diagnose and central nervous system (CNS)/leptomeningeal metastases will be given up to 2 rounds of intracerebroventricular treatment with a radiolabelled monoclonal antibody, 131I-omburtamab to evaluate efficacy and safety

Conditions

Interventions

BIOLOGICAL

131I-omburtamab

Murine IgG1 monoclonal antibody radiolabeled with iodine-131

Sponsors & Collaborators

  • Y-mAbs Therapeutics

    lead INDUSTRY

Principal Investigators

  • John Roemer, MD · Y-mAbs Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2023-06-02
Completion
2023-06-02
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Japan
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03275402 on ClinicalTrials.gov