Neoplasms

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Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Dinutuximab

High-risk neuroblastoma patient treated with Unituxin as standard of care

Unituxin was administered along with cytokines according to the prescribing information

Ami Desai, MD

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.

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.

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

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

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)

The incidence of targeted immune-related adverse events (AEs) during treatment with dinutuximab combination therapy in high-risk neuroblastoma subjects were summarized and listed.

Incidence of neutralizing antibody (NAb) in patients with human anti-chimeric antibody (HACA) positive samples was summarized and listed.

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.

United Therapeutics

High-risk neuroblastoma patient treated with Unituxin as standard of care

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

Dinutuximab Administered for 5 Cycles

Age, Continuous

Age at Diagnosis

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Time since Diagnosis

Induction chemotherapy treatment

Cancer-related surgery

Single stem cell transplant

Tandem stem cell transplant

Radiotherapy treatment

Other cancer-related treatment

Treatment of Neuroblastoma

Pre-Autologous Stem Cell Transplantation (ASCT) Response

Odette Jordan, MD, PMP

High-risk neuroblastoma patient treated with Unituxin as standard of care

Dinutuximab: Unituxin will be administered along with cytokines according to the prescribing information

Outcome measure data were not collected. Sponsor was required to run this Phase 4 study for EU marketing approval. However, Sponsor terminated the study 15 Dec 2016 and application withdrawn (accepted by European Commission 20 Mar 2017).

To Determine the Incidence of Human Anti-chimeric Antibody (HACA) in High-risk Neuroblastoma Patients Treated With Unituxin Combination Therapy.

Outcome measure data were not collected. Safety data from the 12 subjects dosed prior to study termination were collected and summary level data were reported (eg, total number of subjects affected and total number of events for dinutuximab-treated subjects). Please refer to the adverse event tables for results.

To Determine the Incidence of Targeted Immune-related Adverse Events (AEs) During Treatment With Dinutuximab Combination Therapy in High-risk Neuroblastoma Subjects.

Spots Global Cancer Trial Database for Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients

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Study Description

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