The researchers are doing this study to find out whether the radiopharmaceutical therapy (RPT) 177Lu-PSMA-617 is a safe treatment for people with IDH wild type glioma.
Diffuse astrocytoma, IDH-wildtype (grade 2-4)
Glioblastoma, IDH-wildtype
Diffuse midline glioma, H3 K27-altered
Diffuse hemispheric glioma, H3 G34-mutant
Patient known to harbor any other non-canonical IDH mutations (i.e., non-R132H)
Target lesion within 5 mm of either the brainstem, optic chiasm or optic nerves Receipt of bevacizumab as part of the initial treatment for glioma
Life expectancy less than 12 weeks
Nonhealing wound, ulcer or bone fracture
Single group
Temozolomide
DrugPatients will begin taking Temozolomide orally on the first 5 days of each 28-day cycle. The first dose will be given the evening before the first infusion of 177Lu-PSMA- 617.
177Lu-PSMA-617
DrugThis agent will be given for 2-6 total doses, spaced 4 weeks (+/-1 week) apart. This will be administered on the 2nd day of the first two cycles of SOC adjuvant temozolomide.
68Ga-PSMA-PET scan/ MRI
Diagnostic testApproximately 4 weeks after cycle 2 of radiopharmaceutical therapy (RPT), patients will undergo post-treatment imaging with 68Ga- PSMA PET and MRI
Quality of Life Questionnaires
Behavioralbaseline assessments, QOL surveys will be conducted with XeQOL and FACT-Br at 6 months and 12 months post treatment
Descriptively report the toxicity
using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Progression free survival (PFS)
PFS will be defined as the time from treatment initiation to progression of disease as noted radiographically per RANO 2.0 criteria or death, whichever occurred first, and will be analyzed using the Kaplan-Meier method
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Novartis Pharmaceuticals
Collaborator
