177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJakob Stenman
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Pathology 1.1. Histologically confirmed diagnosis of neuroblastoma 1.2. Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available
Relapsed or primary refractory high-risk neuroblastoma: INSS stage 4 disease or INRGSS stage M disease
Age >18 months at the time of enrolment into this study
Life expectancy of greater than 3 months
Disqualifiers
Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the 177Lutetium-DOTATATE SmPC.
Pregnant or lactating patient
Concurrent treatment with any anti-tumor agents
Prior treatment with other radiolabeled somatostatin analogues
Trial design
Design model
Single group
Treatments tested in this trial
177Lu-DOTATATE
Combination productA 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.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: 177Lu-DOTATATEExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) - 1 months after End of Treatment
Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
Time frame
1 months following end of treatmentSecondary outcomes
1
Number and severity of treatment-related adverse events
Number and severity of treatment-related adverse events
Time frame
Up to 5 years after end of treatment2
Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) - 4 months after End of Treatment
Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
Time frame
4 months following end of treatment3
Progression-free survival
Time to progress or death, whichever occurs first
Time frame
Time from registration to progression or death, up to 5 years following end of treatment4
Overall survival - up to 5 years after End of Treatment
Overall survival
Time frame
Time from registration to the the date of death, up to 5 years following end of treatmentOther outcomes
1
Tumour dosimetry: absorbed dose per administration of 177Lu-DOTATATE
Measured by SPECT/CT
Time frame
At every administered dose of 177Lu-DOTATATE throughout the trial treatment phase (5 years)2
Correlation of expression of Somatostatin Receptor-2 (SSTR-2) to uptake on 68Ga-DOTATOC PET/CT
SSTR-2 expression in the histology samples from primary surgery measured by immunohistochemistry.
Time frame
Throughout the trial treatment phase (5 years)3
Uptake on 68Ga-DOTATOC PET/CT
Measured by SUVmax (maximum standardized uptake value)
Time frame
At end of treatment, and 1 and 4 months after end of treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jakob Stenman
Lead sponsor
Karolinska University Hospital
Sponsor institution
Advanced Accelerator Applications
Collaborator
Novartis
Collaborator
Source ClinicalTrials.gov