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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Months - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Pathology 1.1. Histologically confirmed diagnosis of neuroblastoma 1.2. Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available. 2. Relapsed or primary refractory high-risk neuroblastoma: International Neuroblastoma Staging System (INSS) stage 4 disease or International Neuroblastoma Risk Group Staging System (INRGSS) stage M disease. 3. Age >18 months and < 18 years of age at the time of enrolment into this study. 4. Life expectancy of greater than 3 months. 5. Performance Status 5.1. Karnofsky > 50% (for patients > 12 years of age) 5.2. Lansky > 50% (for patients ≤ 12 years of age) 6. Prior treatment 6.1. Two-week washout from any prior treatment 6.2. Patients must have recovery of hematological toxicity following previous therapy 6.3. Adequate recovery from major surgery prior to receiving study treatment. 7. Diagnostic imaging 7.1. Uptake in the primary tumor or metastatic tumour deposits on 68Ga-DOTATATE PET/CT at least higher than the liver uptake and performed within two months prior to registration 7.2. 123I-mIBG scintigraphy to be performed within two months prior to registration 7.3. CT or MRI of the primary tumor and bulky metastatic sites within two months prior to registration. 8. Laboratory requirements to be performed within 7 days prior to commencing trial treatment 8.1. Hematology: 8.1.1. Hemoglobin, If Hb is <120 g/L then patient will receive a blood transfusion prior to commencing trial treatment 8.1.2. Absolute neutrophil count > 1.0 x 109/L 8.1.3. Absolute Platelets > 100 x 109/L 8.2. Biochemistry: 8.2.1. Bilirubin within 1.5 x ULN 8.2.2. ALT within 2.5 x ULN 8.2.3. AST within 2.5 x ULN 8.2.4. GGT within 5 x ULN 8.2.5. ALP within 5 x ULN 8.2.6. Glomerular filtration rate >50mL/min/1.73m2 assessed by a recognised method, such as inulin, 51Cr-EDTA, 99mTc-DTPA or iohexol clearance and performed within 2 months prior to registration 8.2.7. Urinary catecholamine metabolites measured within 2 months prior to registration. 9. Peripheral blood stem cells (PBSC) 9.1. A minimum of 4 x106 CD34+ cells/kg (optimally 6 x106 CD34+ cells/kg) must be available for each study subject prior to registering. 10. Written informed consent from patient and/or parent(s) or legal guardian(s) in accordance with national regulations, prior to registration or any trial-related screening procedures.

Exclusion Criteria:

1. Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the Lutathera SmPC. 2. Pregnant or lactating patient. 3. Concurrent treatment with any anti-tumor agents. 4. Prior treatment with other radiolabeled somatostatin analogues. 5. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient or legal guardian before registration in the trial. 6. Hypersensitivity to any component of the investigational drug Lutathera® 7. Treatment with long-acting somatostatin analogues within 30 days prior the administration of Lutathera®

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04903899
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jakob Stenman
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jakob Stenman, MD PhD
Principal Investigator Affiliation Karolinska University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustryIndustry
Overall Status Recruiting
Countries Denmark, Finland, Lithuania, Netherlands, Norway, Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroblastoma Recurrent, Neuroblastoma
Arms & Interventions

Arms

Experimental: 177Lu-DOTATATE

A total of two doses of 177Lu-DOTATATE will be administered intravenously. The minimum time between treatments is 2 weeks.

Interventions

Combination Product: - 177Lu-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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Rigshospitalet, Copenhagen, Denmark

Status

Not yet recruiting

Address

Rigshospitalet

Copenhagen, , DK-2100

Site Contact

Jesper S Brok, MD PhD

jesper.sune.brok@regionh.dk

(0)51770000

Helsinki, HUS, Finland

Status

Not yet recruiting

Address

New Children's Hospital, Helsinki University Hospital

Helsinki, HUS, FI-00029

Site Contact

Minna Koskenvuo, MD PhD

minna.koskenvuo@hus.fi

(0)51770000

Vilnius University Hospital, Vilnius, Lithuania

Status

Not yet recruiting

Address

Vilnius University Hospital

Vilnius, , LT-08406

Site Contact

Jelena Rascon, MD PhD

jelena.rascon@gmail.com

(0)51770000

Utrecht, Netherlands

Status

Not yet recruiting

Address

Princess Maxima Center for Pediatric Oncology

Utrecht, , NL-3584

Site Contact

Max M van Noesel, MD PhD

M.M.vanNoesel@prinsesmaximacentrum.nl

(0)51770000

Oslo University Hospital, Rikshospitalet, Oslo, Norway

Status

Not yet recruiting

Address

Oslo University Hospital, Rikshospitalet

Oslo, , NO-0372

Site Contact

Kirsten Brunsvig Jarvis, MD

kirjar@ous-hf.no

(0)51770000

Karolinska University Hospital, Stockholm, Sweden

Status

Recruiting

Address

Karolinska University Hospital

Stockholm, , SE-171 76

Site Contact

Kleopatra Georgantzi, MD

kleopatra.georgantzi@sll.se

(0)51770000

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