Clinical trial NCT02693171: Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
Official title: A Post-Marketing Study to Further Assess the Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neuroblastoma
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-02-26
Enrollment: 13
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High-risk neuroblastoma patients prescribed Unituxin

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To Determine the Incidence of Human Anti-chimeric Antibody (HACA) in High-risk Neuroblastoma Patients Treated With Unituxin Combination Therapy.
timeFrame: Approximately 6 months
Secondary outcomes:
measure: To Determine the Incidence of Targeted Immune-related Adverse Events (AEs) During Treatment With Dinutuximab Combination Therapy in High-risk Neuroblastoma Subjects.
timeFrame: Approximately 6 months
measure: To Determine the Incidence of Neutralizing Antibody (NAb) in Patients With Human Anti-chimeric Antibody (HACA) Positive Samples.
timeFrame: Approximately 6 months
measure: To Determine the Effect of HACA on Dinutuximab Plasma Concentrations.
timeFrame: Approximately 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital- San Diego
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan - C S Mott Children's Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota - Minneapolis
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center / Levine Children's Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Children's Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Fort Worth
country: United States
facility: Cook Children's Health Care System
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Ami Desai, MD
role: STUDY_CHAIR
References: