Fractionated dosing of \[211At\]MABG Radiotherapy in Relapsed/Refractory Neuroblastoma
Fractionated dosing of \[211At\]MABG Radiotherapy in Relapsed/Refractory Neuroblastoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Fractionated Dose
West China Hospital
Chengdu, Sichuan, China
RECRUITINGIncidence and severity of dose-limiting toxicities (DLTs)
Incidence and severity of dose-limiting toxicities (DLTs)
Time frame: From administration of [211At]MABG until 4 weeks after injection
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
Time frame: From administration of [211At]MABG until 4 weeks after last dose of injection
Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
Time frame: 8 weeks after [211At]MABG administration, Participants without disease progression (PD) will be evaluated every 8 weeks for the first 24 weeks, then every 12 weeks until PD, new cancer therapy, death, or study termination
Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry
Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry
Time frame: About 21hours from time of [211At]MABG administration]
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