Phase III Study of Lutathera for Recurrent or Progressive High-Grade CNS Tumors and Meningiomas Showing Uptake on DOTATATE PET

What this Trial Is About

Researchers are studying Lutathera 177Lu-DOTATATE, a radionuclide therapy targeting somatostatin receptors, in patients aged 4 to 39 years with progressive or recurrent high-grade central nervous system tumors and meningiomas showing uptake on DOTATATE PET scans. The study aims to evaluate the safety in younger children 4 to <12 years and the efficacy in adolescents and young adults 12 to 239 years. This Phase III trial builds on evidence that these tumors often express the target receptor, which may allow Lutathera to reach and affect tumor cells in the brain. Lutathera is given intravenously every 8 weeks for up to four doses over 8 months. In Phase I children 4 to <12 years, doses start at 200 mCi adjusted for body surface area, with the first cycle used to observe dose-limiting toxicities and establish the recommended dose for Phase II. Phase II patients 12 to 239 years uses the adult recommended dose of 200 mCi every 8 weeks. Tumor response and progression-free survival will be assessed using brain and spine MRI and DOTATATE PET imaging after every one or two cycles. Participants will undergo screening imaging and clinical evaluations before enrollment. During the study, safety will be monitored through adverse event reporting and clinical assessments. Tumor response will be measured by imaging techniques and progression-free survival, with the primary safety evaluation focusing on dose-limiting toxicities in younger patients. The total participation duration may extend up to 8 months, with follow-up assessments planned during and after treatment cycles.

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