XCancer

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

Description:

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

Government Study Link:

NCT05278208 - Click here to see study on

ClinicalTrials.gov

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA
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