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Neuroblastoma clinical trials

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NCT ID: NCT04753658 Terminated - Neuroblastoma Clinical Trials

Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib

Start date: March 19, 2021
Phase:
Study type: Observational

The overall goal of this real-world data collection is to assess demographic, clinical characteristics and real-world effectiveness of pediatric neuroblastoma patients treated with lorlatinib through the expanded access program.

NCT ID: NCT04730349 Terminated - Neuroblastoma Clinical Trials

A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer

PIVOT IO 020
Start date: June 3, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.

NCT ID: NCT04560166 Terminated - Clinical trials for Neuroblastoma Recurrent

Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma

Start date: November 8, 2021
Phase: Phase 2
Study type: Interventional

An International, Single-Arm, Multicenter Phase 2 Trial.

NCT ID: NCT03860207 Terminated - Neuroblastoma Clinical Trials

Study of the Safety and Efficacy of Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb) in Patients With Relapsed/Refractory Neuroblastoma, Osteosarcoma and Other Solid Tumor Cancers

Start date: February 22, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety of a study drug called humanized 3F8 bispecific antibody (Hu3F8-BsAb).

NCT ID: NCT03458728 Terminated - Neuroblastoma Clinical Trials

Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients

Start date: April 30, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.

NCT ID: NCT03275402 Terminated - Neuroblastoma Clinical Trials

131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases

Start date: December 11, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Children with a neuroblastoma diagnose and central nervous system (CNS)/leptomeningeal metastases will be given up to 2 rounds of intracerebroventricular treatment with a radiolabelled monoclonal antibody, 131I-omburtamab to evaluate efficacy and safety

NCT ID: NCT03165292 Terminated - Clinical trials for Very High Risk Neuroblastoma

Evaluation of 2 Intensification Treatment Strategies for Neuroblastoma Patients With a Poor Response to Induction

VERITAS
Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. This evaluation will follow a hierarchical testing procedure: each experimental treatment will be first evaluated as a single-arm phase 2 study, and in case of positive conclusion, the relative efficacy of both arms will then be evaluated comparatively.

NCT ID: NCT02780128 Terminated - Cancer Clinical Trials

Next Generation Personalized Neuroblastoma Therapy

NEPENTHE
Start date: July 2016
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to match genomic aberrations in tumor cells at time of relapse to rationally designed combinations of molecularly targeted agents. This study will be done in two parts: Part I: Tumor will be accessed at study entry via a biopsy and subjected to deep sequencing to identify protocol-specified biomarkers for therapy assignment. Part II: If the tumor contains a genetic change defined by the study as being actionable, and other criteria are met, participants will be assigned to therapy based upon the genetic changes identified in the tumor biopsy.

NCT ID: NCT02693171 Terminated - Neuroblastoma Clinical Trials

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

Start date: March 15, 2016
Phase:
Study type: Observational

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.

NCT ID: NCT02641782 Terminated - Neuroblastoma Clinical Trials

NB2013-HR German (GPOH) / Dutch (DCOG) Trial

NB2013-HR
Start date: November 2015
Phase: Phase 2
Study type: Interventional

Although the five year survival rate of children with high risk neuroblastoma have increased over the last three decades from 4 to 44 % (1), neuroblastoma is the second most frequent cause for cancer related death in childhood (11 %). Most patients show good initial response rates (complete (CR) and partial remission (PR) rate 95 %), but 55 % experience a largely treatment-resistant tumor progression. Recently, a breakthrough with immunotherapy was reported by US investigators from the Children's Oncology Group (2) using the anti-ganglioside D2 (GD2) monoclonal antibody ch14.18 for tumor cell destruction and granulocyte macrophage-colony stimulating factor (GM-CSF) plus interleukin 2 (IL-2) for immunostimulation. This immune therapy resulted in an increase of 20 % Event free survival (EFS) at 2 year from randomization. However, this was associated with a high toxicity rate (pain, capillary leak syndrome). The proposed trial compares the Childrens' Oncology Group (COG) "standard of care" arm (anti-GD2 + GM-CSF + IL-2 i.v. + retinoic acid oral) with an experimental arm (anti-GD2 + GM-CSF + IL-2 s.c. + retinoic acid oral) designed to reduce toxicity. The potential benefit from this trial consists of the confirmation that the American trial design is feasible in an independent set of patients with different preceding therapy, at a different time point regarding to immune reconstitution after autologous stem cell transplantation (ASCT), the feasibility of a newly designed immunotherapy (which is hopefully less toxic) and the investigation of immune response parameters. This pilot study is the prerequisite for a consecutive randomized clinical trial comparing two immunotherapeutic approaches in a larger set of patients.