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

Terminated

Conditions: Neuroblastoma

Interventions: Drug: Dinutuximab

Registration Number: NCT02693171

Lead Sponsor: United Therapeutics

Brief Summary: 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.

Detailed Description: This was a multi-center, non-randomized, open-label study in patients with high-risk neuroblastoma to assess the immunogenicity, safety and tolerability of Unituxin combination therapy. Patients enrolled in the study were prescribed Unituxin for the treatment of high-risk neuroblastoma.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 13

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dinutuximab administered for 5 cycles	Dinutuximab	High-risk neuroblastoma patient treated with Unituxin as standard of care

Primary Outcome Measures

Name	Time	Method
To Determine the Incidence of Human Anti-chimeric Antibody (HACA) in High-risk Neuroblastoma Patients Treated With Unituxin Combination Therapy.	Approximately 6 months	Seven blood samples were collected at the following time points for the evaluation of HACA levels: * Course 1- Prior to the first Unituxin infusion * Course 2- Prior to the first Unituxin infusion * Course 3- Prior to the first Unituxin infusion * Course 4- Prior to the first Unituxin infusion * Course 5- Prior to the first Unituxin infusion * Course 6- Prior to the first dose of 13-cis-retinoic acid (RA) * Study termination (approximately 2 weeks following the final 13-cis-retinoic acid dose)

Secondary Outcome Measures

Name	Time	Method
To Determine the Incidence of Neutralizing Antibody (NAb) in Patients With Human Anti-chimeric Antibody (HACA) Positive Samples.	Approximately 6 months	Incidence of neutralizing antibody (NAb) in patients with human anti-chimeric antibody (HACA) positive samples was summarized and listed.
To Determine the Incidence of Targeted Immune-related Adverse Events (AEs) During Treatment With Dinutuximab Combination Therapy in High-risk Neuroblastoma Subjects.	Approximately 6 months	The incidence of targeted immune-related adverse events (AEs) during treatment with dinutuximab combination therapy in high-risk neuroblastoma subjects were summarized and listed.
To Determine the Effect of HACA on Dinutuximab Plasma Concentrations.	Approximately 6 months	Ten blood samples were collected at the following time points for the evaluation of dinutuximab plasma concentrations: * Course 1- Prior to the first Unituxin infusion * Course 2- Prior to the first Unituxin infusion * Course 3- Prior to the first Unituxin infusion * Course 4- Prior to the first Unituxin infusion * Course 5- Prior to the first Unituxin infusion * Course 6- Prior to the first dose of 13-cis-retinoic acid (RA) * Study termination (approximately 2 weeks following the final 13-cis-retinoic acid dose). An additional 3 blood samples were obtained for the evaluation of dinutuximab plasma concentrations. Each of these blood samples was obtained immediately following the fourth dinutuximab infusion in Courses 1, 3, and 5.

Trial Locations

Locations (18): University of Chicago
🇺🇸
Chicago, Illinois, United States
Duke University Medical Center
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Durham, North Carolina, United States
Dana Farber Cancer Institute
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Boston, Massachusetts, United States
University of Michigan - C S Mott Children's Hospital
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Ann Arbor, Michigan, United States
Children's Hospital Los Angeles
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Los Angeles, California, United States
University Of Alabama At Birmingham
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Birmingham, Alabama, United States
Arkansas Children's Hospital
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Little Rock, Arkansas, United States
Children's Hospital of Orange County
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Orange, California, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, United States
Carolinas Medical Center / Levine Children's Hospital
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Charlotte, North Carolina, United States
Rady Children's Hospital- San Diego
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San Diego, California, United States
Children's Mercy Hospital
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Kansas City, Missouri, United States
Nationwide Children's Hospital
🇺🇸
Columbus, Ohio, United States
Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, United States
Seattle Children's Hospital
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Seattle, Washington, United States
Penn State Hershey Children's Hospital
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Hershey, Pennsylvania, United States
Cook Children's Health Care System
🇺🇸
Fort Worth, Texas, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States