67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neuroblastoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
This study is to be conducted in 2 phases, a dose escalation phase and a cohort expansion phase. Dose escalation will be completed using a modified 3+3 study design with up to 4 Cohorts of increasing doses in MBq/kg. Pre-defined Dose Limiting Toxicities will be monitored for 6 weeks post administrat...
This study is to be conducted in 2 phases, a dose escalation phase and a cohort expansion phase. Dose escalation will be completed using a modified 3+3 study design with up to 4 Cohorts of increasing doses in MBq/kg. Pre-defined Dose Limiting Toxicities will be monitored for 6 weeks post administration of 67Cu-SARTATE. Once either the MTD for a single administration of 67Cu-SARTATE is established, or Cohort 4 has been completed, the study will be expanded to enroll an additional 10 subjects who will receive 2 therapy cycles of 67Cu-SARTATE at the MTD dose level.
Tracking Information
- NCT #
- NCT04023331
- Collaborators
- Not Provided
- Investigators
- Not Provided
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