drugset / Trial / NCT05278208

Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors

NCT05278208

Phase 1/2 Recruiting 65 enrolled Nationwide Children's Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \<12 years (Phase I) or 12 to \</=39 years (Phase II) to test its safety and efficacy, respectively. Funding Source - FDA OOPD (grant number FD-R-0532-01)

Timeline

Start
2022-11-21
Primary completion
2028-11
Completion
2033-11

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-DOTATATE Peptide 150 unknown Intravenous
Subject 177Lu-DOTATATE Peptide 200 unknown Intravenous
Subject 177Lu-DOTATATE Peptide 250 unknown Intravenous