Study of Lutetium Lu 177 Dotatate LUTATHERA to Treat Inoperable, Progressive Meningioma After Radiation Therapy

What this Trial Is About

Researchers are evaluating lutetium Lu 177 dotatate LUTATHERA, a radioactive drug given through a vein, for treating patients with meningioma tumors that cannot be removed by surgery and have worsened after radiation therapy. This phase II study aims to find out if LUTATHERA is safe and effective in slowing tumor growth or improving survival in patients with different grades of recurrent meningioma. It also explores how well imaging methods can assess treatment response and how treatment affects patients quality of life. Participants receive gallium Ga 68-DOTATATE intravenously and undergo PETMRI or PETCT scans before the first and fourth treatment cycles to evaluate tumor activity. They then get LUTATHERA through an IV infusion lasting 30 to 40 minutes every 8 weeks, for up to four cycles if the disease does not worsen and side effects are manageable. Additional imaging, including MRI, blood tests, and possibly SPECTCT scans, are done during treatment to monitor effects and radiation dosing. During the study, patients have regular MRI scans, blood collections, and quality of life questionnaires. After completing treatment, participants are followed every 3 months for 2 years and then every 6 months up to 5 years to track progression-free survival, overall survival, and side effects. Researchers analyze treatment outcomes using standardized criteria and assess radiation doses to tumors and organs. The total involvement can last several years with close monitoring.

Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy