A Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu… (NCT03966651) | Clinical Trial Compass
CompletedPhase 1
A Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate in Children With Refractory or Recurrent Neuroblastoma Expressing Somatostatin Receptors.
France1 participantsStarted 2023-04-17
Plain-language summary
This study is a multicenter, open label phase I dose escalation trial designed to define the Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE in children with refractory or recurrent neuroblastoma.
177Lu-DOTATATE will be delivered intravenously for 2 cycles, 6 weeks apart.
The duration of study participation of each patient will be 5 months.
Who can participate
Age range1 Year – 18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed diagnosis of neuroblastoma (patients can be included whatever the results of the 123ImIBG scan).
✓. Recurrent or refractory neuroblastoma following at least two prior standard treatment regimen.
✓. Positive 68Ga-DOTATOC PET within 6 weeks prior to day 1 dosing. Note: PET positivity is visually defined as follow: uptake should be equivalent or higher than the liver uptake for all lesions identified by conventional neuroblastoma imaging working.
✓. Patient for whom no effective conventional therapy exists.
✓. a) For dose levels 1 (80 MBq/kg) \& 2 (100 MBq/kg): Age \> 1 year and \< 18 years at the time of enrollment into the study. b) For dose level 3 (120 MBq/kg):
✓. Life expectancy greater than 3 months.
✓. Adequate performance Status defined as: Karnofsky or Lansky Play Performance Scale ≥ 50% (depending on patient's age).
✓. Adequate recovery from major surgery prior to receiving study treatment.
Exclusion criteria
✕. Children with negative 68Ga-DOTATOC PET.
✕. Chemotherapy within 4 weeks prior to the start of study treatment, high dose chemotherapy with stem cell transplantation within 3 months prior to start study treatment, long acting somatostatin analogues within 30 days prior to start of study treatment, biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first.
What they're measuring
1
The Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE
✕. Any previous molecular radiotherapy (PRRT, 131ImiBG or other)
✕. External Beam Radiation (EBR) therapy within 30 days before starting study treatment.
✕. Prior extensive EBR therapy:
✕. Known brain metastases, unless these metastases have been treated and stabilized for at least 3 months prior to enrolment in the study. Patients with a history of brain metastases must have a head CT or MRI with contrast to document stable disease prior to enrolment in the study.
✕. Other known co-existing malignancies.
✕. Hypersensitivity to 177Lu-DOTATOC, amino acid solution or 68GaDOTATATE.