At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed neuroblastoma diagnosis
- ✓Relapsed or primary refractory high-risk neuroblastoma (INSS stage 4 or INRGSS stage M)
- ✓Age greater than 18 months at enrollment
- ✓Life expectancy greater than 3 months
- ✕Not fit enough to undergo proposed study treatment per national PI assessment
- ✕Pregnant or lactating patient
- ✕Concurrent treatment with any anti-tumor agents
- ✕Prior treatment with other radiolabeled somatostatin analogues
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04903899Phase 2RecruitingMonitorUpdated 16mo ago · Completion was 1mo agoA Phase II Trial of 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
In Brief
A Phase 2 clinical trial evaluating 177Lu-DOTATATE for Neuroblastoma Recurrent and Neuroblastoma. Currently recruiting, targeting 24 participants across 5 sites in 5 countries.
Signals
Detailed Summary
The LuDO-N Trial is a multi-centre phase II clinical trial on 177Lu-DOTATATE treatment of recurrent or relapsed high-risk neuroblastoma in children. The LuDO-N Trial builds on the experience from the previous LuDO Trial and utilises an intensified dosing schedule to deliver 2 doses over a 2-week period, in order to achieve a maximal effect on the often rapidly progressing disease. This strategy requires a readiness for autologous stem cell transplantation in all patients, but is not anticipated to increase the risk of long-term sequelae, since the cumulative radiation dose remains unchanged. The primary aim of the study is to assess the response to 177Lu-DOTATATE treatment at 1 and 4 months after ende of treatment. Secondary aims are to assess survival and treatment-related toxicity. Additional aim are to correlate tumour dosimetry with response, correlate SSTR-2 expression with 68Ga-DOTATATE uptake and to correlate the uptake with the treatment response.
Study Details
Timeline
Interventions
A weight-based activity of 200 MBq kg-1 will be used for the first dose. The activity of the second dose will be calculated based on whole body activity scans as well as SPECT CT scans to determine the absorbed kidney dose. The aim is to administer 177Lu-DOTATATE corresponding to a whole-body dose of 1,2 Gy, with a cumulative whole-body dose of about 2,4 Gy over two courses, and not exceeding a cumulative renal dose of 23 Gy, in order to avoid renal toxicity.