Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients

Stopped early

Conditions studied: Neuroblastoma

In brief

The purpose of this study was to assess the incidence of human anti-chimeric antibody (HACA) in high-risk neuroblastoma patients treated with Unituxin combination therapy.

Key facts

Study ID

NCT02693171

Run by

United Therapeutics

People needed

13

Starts

2016-03-15

Expected to finish

2016-12-19

Last updated by the study team

2019-08-05

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient had been diagnosed with high-risk neuroblastoma.
• Patient had been prescribed Unituxin and plans to start Unituxin therapy within 30 days of study entry.
• Patient started Unituxin therapy no later than 200 days after Autologous Stem Cell Transplantation (ASCT).
• Written informed consent / assent was obtained in accordance with institutional and International Conference on Harmonisation (ICH) guidelines.

You may not qualify if…

• Patient had received prior anti-disialoganglioside (anti-GD2) antibody therapy.
• Patient had participated in an investigational clinical trial with tumor therapeutic intent within 30 days of informed consent.
• Patient underwent Autologous Stem Cell Transplantation (ASCT) more than 200 days prior to receiving Unituxin therapy.

Where it is running

• University Of Alabama At Birmingham — Birmingham, Alabama, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Rady Children's Hospital- San Diego — San Diego, California, United States
• University of Chicago — Chicago, Illinois, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan - C S Mott Children's Hospital — Ann Arbor, Michigan, United States
• Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Carolinas Medical Center / Levine Children's Hospital — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Penn State Hershey Children's Hospital — Hershey, Pennsylvania, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Cook Children's Health Care System — Fort Worth, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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