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

NCT05278208 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-04-13

No results posted yet for this 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)

Conditions

  • 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

Interventions

DRUG

LUTATHERA® (Lutetium Lu 177 dotatate)

Lutathera: IV administration maximum dose of 200 mCi once every 8 weeks (one cycle) for total of 4 cycles (8 months)

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Margot Lazow, MD · Nationwide Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2028-11-30
Completion
2033-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05278208 on ClinicalTrials.gov