Racotumomab in Patients With High-risk Neuroblastoma

Neuroblastoma Clinical Trial

Official title: Open-label, Multicenter, Phase II Immunotherapy Study With Racotumomab in Patients With High-risk Neuroblastoma

Status Completed

Clinical Trial Summary

This clinical trial will be carried out in children diagnosed with high-risk neuroblastoma that have achieved a complete or very good partial response after standard therapy. An additional cohort of children who could not achieve these response criteria or that relapsed after standard therapy but do not have progressive disease will receive Racotumomab together with metronomic chemotherapy.

The main objectives of this study are to determine the immune response after one-year duration immunization with Racotumomab, to describe the response of Racotumomab therapy in minimal residual disease (MRD) in bone marrow and to describe the toxicity profile of Racotumomab.

Clinical Trial Description

Neuroblastoma is the most common extra-cranial tumor in childhood but prognosis is still poor, even with the advances in its treatment.

New therapeutic strategies have been examined, and several immunotherapeutic approaches, including combined therapy with monoclonal antibodies (anti-GD2), intravenous interleukin-2 (Il-2) and intravenous granulocyte-macrophage colony-stimulating factor (GM-CSF), and anti-idiotype vaccines are currently being assessed.

Racotumomab is an anti-idiotype antibody capable of inducing anti-N-glycolyl GM3 antibodies in patients with neuroblastoma.

The expression of the ganglioside N-glycolyl GM3 was shown in neuroblastoma and this expression could be useful as a specific target for immunotherapy.

Ractoumomab will be administered once standard therapy for neuroblastoma has been completed. ;

Related Conditions & MeSH terms

• Neuroblastoma

• NCT number: NCT02998983
• Study type: Interventional
• Source: Laboratorio Elea Phoenix S.A.
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Completion date: November 2022