DIV-NB-401: A Post-Marketing Study to Further Assess the Immunogenicity and Safety of Unituxin (Dinutuximab, monocolonal antibody ch14.18) in High-Risk Neuroblastoma Patients
Sponsor: |
United Therapeutics Corp. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAQ6521 |
Contact: |
Alice Lee: 212-305-5808 / al2041@cumc.columbia.edu |
The purpose of this research study is to collect information about the percentage of people that develop HACA when they are treated with Unituxin and determine if HACA affects the blood levels of Unituxin. Unituxin is a type of antibody. Antibodies are made by the body to attack tumors and fight infections. Unituxin is a chimeric antibody which means it is made in the lab using cells from both mice and humans. Unituxin reacts with a substance (GD2) made by neuroblastoma cancer cells. By attaching to GD2, Unituxin helps your bodys immune system find and attack the cancer. Sometimes people who receive drugs made with cells from a mouse develop an antibody to them, called human anti-chimeric antibody (HACA). High levels of HACA can change the amount of Unituxin in your blood.
This study is closed
Investigator
Alice Lee, MD
Does you child have neuroblastoma? |
Yes |
No |