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 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)

Trial Details

NCT ID
NCT05278208
Phase
PHASE1 / PHASE2
Sponsor
Nationwide Children's Hospital
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • LUTATHERA® (Lutetium Lu 177 dotatate)
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Cincinnati, Ohio, United States|39.12711,-84.51439
  • Columbus, Ohio, United States|39.96118,-82.99879
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

  • Screening Criteria
  • 1 Diagnosis Patient must have a diagnosis of primary high-grade CNS tumor (any histopathologic diagnosis that is WHO grade III-IV) or meningioma (a…
  • Note: Refractory disease is defined as the presence of persistent abnormality on conventional MRI that is further distinguished by histology (biops…
  • 2 Prior Therapy Patients must have recurred/progressed following prior standard therapy for their tumor. Note: Patients with meningioma, atypical m…

For full eligibility, visit ClinicalTrials.gov.

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