Clinical trialNCT05278208RecruitingPhase 1/PHASE2Interventional

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

SponsorNationwide Children's HospitalEnrollment65Anaplastic EpendymomaEmbryonal TumorHigh Grade GliomaMedulloblastomaMeningiomaRecurrent Diffuse Intrinsic Pontine Glioma+7 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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)

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Margot Lazow, MD
Nationwide Children's Hospital
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S Hospital Colorado
Aurora, Colorado, United States
Withdrawn
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Recruiting
Nationwide Children'S Hospital
Columbus, Ohio, United States
Recruiting
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

LUTATHERA®

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 21 Nov 2022
Primary completion: 30 Nov 2028
Completion: 30 Nov 2033
Last update posted: 20 Jul 2026
Registered enrollment: 65
Registry id: NCT05278208

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.