Children and adolescents diagnosed with medullablastoma and with recurrent or refractory to frontline therapy will be treated with 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3.
Part 1 is a dose-escalation phase with a 3+3 sequential-group design in which patients will receive a dosimetry dose followed by maximum of two 5-week cycles of treatment doses of intracerebroventricular 177Lu-DTPA-omburtamab. Part 2 is a cohort-expansion phase in which patients will receive a maximum of five 5-week cycles of intracerebroventricular 177Lu-DTPA-omburtamab at the recommended dose determined in Part 1. End of treatment will take place within 5 weeks after the last cycle and thereafter the patients will be enter the follow-up period. The patients will be followed for up to 2 years after last dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Biological, radiolabeled DPTA-omburtamab
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Doernbecher Children's Hospital
Portland, Oregon, United States
M.D. Anderson Cancer Center
Dose Limiting Toxicities (DLTs) Part 1
Summary of DLTs in DLT evaluable subjects.
Time frame: Days 1 through 35 in cycle 1
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Houston, Texas, United States
Rigshospitalet, Børneonkologisk afsnit
Copenhagen, Denmark
Princess Máxima
Utrecht, Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Sant Joan de Deu de Barcelona
Barcelona, Spain
The Royal Marsden Hospital
London, United Kingdom
Great North Children's Hospital
Newcastle, United Kingdom