Phase II Study of 177Lutetium-DOTATATE Treatment for Children Over 18 Months With Relapsed or Primary Refractory High-risk Neuroblastoma

What this Trial Is About

The LuDO-N Trial is a phase II multi-center clinical study investigating the use of 177Lu-DOTATATE in children with recurrent or relapsed high-risk neuroblastoma. This trial aims to assess how well this treatment works by measuring the response at 1 and 4 months after treatment ends. Secondary goals include evaluating survival rates, treatment-related side effects, and examining how tumor characteristics relate to treatment response. Participants receive two doses of 177Lu-DOTATATE administered intravenously, with at least two weeks between doses. The first dose is based on the patients weight, while the second dose is adjusted using scans to control radiation exposure, particularly to avoid kidney toxicity. Patients must be prepared for autologous stem cell transplantation as part of this intensified treatment approach. During the study, participants will undergo various scans and laboratory tests before starting treatment and at scheduled times to monitor tumor response and side effects. Researchers will assess treatment effectiveness using established neuroblastoma response criteria and will follow patients for up to five years to monitor survival and any long-term effects. The total participation time includes treatment administration and extended follow-up for safety and outcomes.

177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma