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NCT05278208 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of High Grade Glioma and Medulloblastoma, sponsored by Nationwide Children's Hospital.

Recruiting
Registry status
Phase 1
Development phase
65
Enrollment target
4
Study locations

NCT05278208: Recruiting Phase 1 study of High Grade Glioma and Medulloblastoma, sponsored by Nationwide Children's Hospital.

NCT05278208 is a Phase 1 study of High Grade Glioma and Medulloblastoma that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 65 participants, roughly in line with the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target. The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05278208, a Phase 1 study of High Grade Glioma and Medulloblastoma, is actively recruiting participants, sponsored by Nationwide Children's Hospital.

RECRUITING
Registry status
Phase 1
Development phase
65 participants
Enrollment target
4
Study locations

Study 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)

Primary Outcome

To estimate the maximum tolerated dose (MTD) of Lutathera in pediatric patients between 4 and 12 to \</=39 yearsof age with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET.

Conditions Studied

High Grade Glioma Medulloblastoma Meningioma Recurrent Malignant Glioma Recurrent Medulloblastoma Recurrent Diffuse Intrinsic Pontine Glioma Anaplastic Ependymoma Refractory Diffuse Intrinsic Pontine Glioma Recurrent Primary Central Nervous System Neoplasm Embryonal Tumor

Interventions

  • DRUG LUTATHERA® (Lutetium Lu 177 dotatate)

Study Locations (4)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati
  • Nationwide Children's Hospital - Columbus

Colorado

  • Children's Hospital Colorado - Aurora

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2022-11-21
Est. Completion 2027-11
Phase Phase 1
Nationwide Children's Hospital

188 total trials

What NCT05278208 shows while recruiting

NCT05278208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target.

The record links to 10 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 1 intervention - of which LUTATHERA® (Lutetium Lu 177 dotatate) is the first listed.

NCT05278208 reports a single indexed study location in Ohio, Colorado, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05278208 about?

NCT05278208 is a clinical study titled "Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors". 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 t...

What is the current status of trial NCT05278208?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2022-11-21. Estimated completion is 2027-11.

What conditions does trial NCT05278208 study?

This clinical trial studies the following conditions: High Grade Glioma, Medulloblastoma, Meningioma, Recurrent Malignant Glioma, Recurrent Medulloblastoma.

What interventions are being tested in trial NCT05278208?

The interventions under investigation include: LUTATHERA® (Lutetium Lu 177 dotatate) (DRUG).

Who is sponsoring clinical trial NCT05278208?

This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05278208 being conducted?

This trial has 4 study locations across Colorado, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for High Grade Glioma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05278208's enrollment target sits among peer trials

65 8th of 42 higher than 35 of 42 other High Grade Glioma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other High Grade Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05278208

Source: ClinicalTrials.gov NCT05278208, the US trial registry maintained by the National Library of Medicine. NCT05278208 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.