RecruitingPhase 2NCT04903899

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

A Phase II Trial of 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma


Sponsor

Jakob Stenman

Enrollment

24 participants

Start Date

May 19, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Months

Plain Language Summary

Simplified for easier understanding

This study tests a targeted radiation therapy called Lutetium-177 DOTATATE in children with high-risk neuroblastoma (an aggressive childhood cancer) that has come back or didn't respond to initial treatment. The treatment works by delivering radiation directly to tumor cells that carry a specific receptor. **You may be eligible if...** - You are older than 18 months at the time of enrollment - You have high-risk neuroblastoma that has relapsed or did not respond to first-line therapy - Your tumor shows uptake of a specific imaging agent (68Ga-DOTATATE) on a PET scan - Your life expectancy is greater than 3 months - You are in reasonable functional health (Lansky or Karnofsky score above 50%) **You may NOT be eligible if...** - You have not recovered from side effects of previous treatments - Your blood counts or organ function have not recovered sufficiently - You have had treatment within the past 2 weeks without a proper washout period - Your imaging does not show adequate tumor uptake of the radiotracer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCT177Lu-DOTATATE

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.


Locations(5)

Rigshospitalet

Copenhagen, Copenhagen, Denmark

Vilnius University Hospital

Vilnius, Vilnius County, Lithuania

Princess Maxima Center for Pediatric Oncology

Utrecht, Utrecht, Netherlands

Oslo University Hospital, Rikshospitalet

Oslo, Oslo, Norway

Karolinska University Hospital

Stockholm, Stockholm County, Sweden

View Full Details on ClinicalTrials.gov

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NCT04903899


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