Racotumomab in Patients With High-risk Neuroblastoma

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.

Timeline

Start

2016-11

Primary completion

2022-11

Completion

2022-11

Publications

• Felizzia G, Segatori VI, Galluzzo L, Alonso DF, Pinto N, Sobrero V, Varela M, Veron D, Gulino CA, Eberle SE, Fernandez D, Guthmann M, Tinelli M, Lombas C, Spitzer E, Demarco I, Montanari A, Basile C, Odella J, Posadas D, Viso M, Villar MV, Pires C, Bevilacqua G, Rubio P, Alonso C, Rossi J, Casanello AL, Rizzi A, Mascardi R, Salvador V, Ardiles N, Zubizarreta P, Cacciavillano W. Immune Response and Safety of Anti-NeuGcGM3 Anti-Idiotype Vaccine Racotumomab in Patients With High-Risk Neuroblastoma: An Open-Label, Single-Arm, Multicenter Phase 2 Study in Argentina. Pediatr Blood Cancer. 2026 Aug;73(8):e70394. doi: 10.1002/1545-5017.70394. Epub 2026 May 14.

Drugs

Indications