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

Neuroblastoma Clinical Trial

Official title:

A Post-Marketing Study to Further Assess the Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02693171
• Other study ID #: DIV-NB-401
• Status: Terminated
• Start date: March 15, 2016
• Est. completion date: December 19, 2016

Study information

• Verified date: June 2019
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 19, 2016
• Est. primary completion date: December 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• Dinutuximab
Unituxin was administered along with cytokines according to the prescribing information

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Determine the Incidence of Human Anti-chimeric Antibody (HACA) in High-risk Neuroblastoma Patients Treated With Unituxin Combination Therapy.	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)	Approximately 6 months
Secondary	To Determine the Incidence of Targeted Immune-related Adverse Events (AEs) During Treatment With Dinutuximab Combination Therapy in High-risk Neuroblastoma Subjects.	The incidence of targeted immune-related adverse events (AEs) during treatment with dinutuximab combination therapy in high-risk neuroblastoma subjects were summarized and listed.	Approximately 6 months
Secondary	To Determine the Incidence of Neutralizing Antibody (NAb) in Patients With Human Anti-chimeric Antibody (HACA) Positive Samples.	Incidence of neutralizing antibody (NAb) in patients with human anti-chimeric antibody (HACA) positive samples was summarized and listed.	Approximately 6 months
Secondary	To Determine the Effect of HACA on Dinutuximab Plasma Concentrations.	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.	Approximately 6 months