Clinical Trial · NCT05278208

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

Overview

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)

Sponsor

Nationwide Children's Hospital

Phase

Phase 1/2

Contacts

Margot Lazow, MD (PRINCIPAL_INVESTIGATOR)

Kelsey H Troyer, PhD (CONTACT)

kelsey.troyer@nationwidechildrens.org

614-722-8566

ClinicalTrials.gov

NCT05278208

Drug / Compound

DOTATATE

Isotope(s):

Target(s):

SSTR2

Ligand Class: Peptides

Chelator: DOTA

DOTATATE

Isotope(s):

Target(s):

SSTR2

Ligand Class: Peptides

Chelator: DOTA

Eligibility

Inclusion

Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient's prior malignancy has been in remission for at least 5 years from the end of treatment.
1 Confirmed bone marrow metastatic disease Patients with confirmed metastatic disease to bone marrow are ineligible.
2 Prior Therapy Patients must have recurred/progressed following prior standard therapy for their tumor. Note: Patients with meningioma, atypical meningioma, or anaplastic meningioma must have received at least surgical resection or radiation.
Tumor with evidence of clinically significant uncal herniation or midline shift.

Exclusion

Exclusion criteria not yet provided.