Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: High Grade Glioma, Meningioma, Embryonal Tumor, Medulloblastoma, Anaplastic Ependymoma, Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Primary Central Nervous System Neoplasm, Refractory Diffuse Intrinsic Pontine Glioma, Refractory Malignant Glioma, Refractory Medulloblastoma, Refractory Primary Central Nervous System Neoplasm
In brief
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)
Key facts
- Study ID
- NCT05278208
- Run by
- Nationwide Children's Hospital
- People needed
- 65
- Starts
- 2022-11-21
- Expected to finish
- 2033-11-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 4 and older, up to 39. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
- Children's Hospital Colorado — Aurora, Colorado, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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