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.
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed diagnosis of neuroblastoma (patients can be included whatever the results of the 123ImIBG scan). 2. Recurrent or refractory neuroblastoma following at least two prior standard treatment regimen. 3. 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. 4. Patient for whom no effective conventional therapy exists. 5. 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): \- If at least one patient \< 2 years old has been enrolled in one of the previous dose levels (80 or 100 MBq/kg): Age \> 1 year and \< 18 years at the time of enrollment into the study. \- If no patient \< 2 years old was enrolled in one of the previous dose levels (80 or 100 MBq