Recurrent or refractory neuroblastoma.
Conditions
Brief summary
The primary endpoint is to define the Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE. DLT period will start from the first injection of 177Lu- DOTATATE until 6 weeks after 1st injection.
Detailed description
Safety will be evaluated using NCI CTCAE V5.0 and clinical dosimetry of the blood and kidneys., Total Absorbed dose to the kidneys (considering both previous absorbed dose due to external beam irradiation and 177Lu-DOTATATE irradiation) will be defined., Efficacy: will be evaluated using the INRC (2017), RECIST v1.1 criteria and investigator judgment. Objective Response Rate (ORR) will be defined as the number of patients with best objective response (i.e. complete response or partial response) divided by the total number of evaluable patients. Progression Free Survival (PFS) will be defined as the time from inclusion to progression or death due to any cause. Overall Survival (OS) will be defined as the time from inclusion to death due to any ca
Interventions
Sponsors
Oncopole Claudius Regaud
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to define the Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE. DLT period will start from the first injection of 177Lu- DOTATATE until 6 weeks after 1st injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be evaluated using NCI CTCAE V5.0 and clinical dosimetry of the blood and kidneys., Total Absorbed dose to the kidneys (considering both previous absorbed dose due to external beam irradiation and 177Lu-DOTATATE irradiation) will be defined., Efficacy: will be evaluated using the INRC (2017), RECIST v1.1 criteria and investigator judgment. Objective Response Rate (ORR) will be defined as the number of patients with best objective response (i.e. complete response or partial response) divided by the total number of evaluable patients. Progression Free Survival (PFS) will be defined as the time from inclusion to progression or death due to any cause. Overall Survival (OS) will be defined as the time from inclusion to death due to any ca | — |
Countries
France
Outcome results
None listed