Actively Recruiting
Phase 1 Study of Lutetium-177-PSMA-617 Radiotherapy with Temozolomide for Adults with IDH Wild Type Gliomas
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-06-04
20
Participants Needed
7
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a radiopharmaceutical therapy called 177Lu-PSMA-617 in people with IDH wild type glioma, a type of brain tumor. This phase 1 study focuses on patients with specific gliomas that express PSMA, aiming to understand the treatments toxicity and disease progression after standard care. Participants will receive 177Lu-PSMA-617 for 2 to 6 doses, spaced about 4 weeks apart, given alongside standard oral Temozolomide chemotherapy. Temozolomide is started the night before each infusion of 177Lu-PSMA-617 for the first two cycles. After treatment, brain MRI scans will be done every 2 months, with additional 68Ga-PSMA-PET scans performed one month after the second dose and if the disease shows progression. Throughout the study, participants will complete quality of life questionnaires at baseline, and 6 and 12 months after treatment. Researchers will monitor toxicity up to 8 weeks after the first infusion and track progression-free survival for 2 years. The study involves regular imaging, lab tests, and clinical assessments to evaluate safety and disease status over time, with participation lasting according to these follow-up periods.
CONDITIONS
Brief Title
A Study of 177Lu-PSMA-617 in People With Gliomas
Research Team
B
Brandon Imber, MD
T
Thomas Kaley, MD
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