Phase I/II Study of Lutathera in Patients With Recurrent and/or Progressive High-Grade Central Nervous System Tumors and Meningiomas That Demonstrate Uptake on DOTATATE PET

What this Trial Is About

Researchers are studying Lutathera (177Lu-DOTATATE) for treating patients aged 4 to 39 years with progressive or recurrent high-grade central nervous system tumors and meningiomas that show uptake on DOTATATE PET scans. This study aims to evaluate the safety in younger children (4 to under 12 years) and the effectiveness in adolescents and young adults (12 to 39 years) through a Phase I/II clinical trial. The background highlights that somatostatin receptors, targeted by Lutathera, are often present in these tumor types and may influence tumor growth. Participants receive Lutathera as an intravenous infusion once every 8 weeks, for a total of up to 4 doses over 8 months. In Phase I, children aged 4 to under 12 years receive an adjusted dose based on body surface area to assess safety and determine the optimal dose. In Phase II, patients aged 12 to 39 years receive the adult recommended dose to evaluate tumor response. Imaging with brain/spine MRI and DOTATATE PET will monitor treatment effects after every cycle or every other cycle. Throughout the study, patients undergo regular assessments including imaging scans, neurological exams, and laboratory tests to monitor organ function and treatment side effects. Researchers track adverse events and tumor progression, focusing on progression-free survival in older patients. The study lasts up to 8 months with close safety monitoring during and after treatment. Participants must meet specific health and tumor criteria confirmed by imaging before enrollment.

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