Clinical Trial

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

Recruiting Phase 1/2

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)

Protocol Amendment History 16 amendments

This ClinicalTrials.gov record has been amended 16 times since 2022-03-03; most recent amendment 2026-07-17.

Status change: Not Yet Recruiting → Recruiting 2023-01-16

Trial Details

NCT Number	NCT05278208
Lead Sponsor	Nationwide Children's Hospital
Conditions	High Grade Glioma, Meningioma, Embryonal Tumor, Medulloblastoma, Anaplastic Ependymoma, Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Malignant Glioma, Recurrent Medulloblastoma +5 more
Enrollment	65 participants
Start Date	2022-11-21
Primary Completion	2028-11 (estimated)
Study Completion	2033-11 (estimated)
Updated on ClinicalTrials.gov	2026-07-20