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Recruiting Phase 1 NCT07223034

A Study of 177Lu-PSMA-617 in People With Gliomas

Trial Parameters

Condition Glioma
Sponsor Memorial Sloan Kettering Cancer Center
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-10-27
Completion 2027-10
Interventions
Temozolomide177Lu-PSMA-61768Ga-PSMA-PET scan/ MRI

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Confirmed histologic diagnosis of a WHO grade 2-4 glioma that is IDH1 R132H-wildtype, including the following: * Diffuse astrocytoma, IDH-wildtype (grade 2-4) * Glioblastoma, IDH-wildtype * Diffuse midline glioma, H3 K27-altered * Diffuse hemispheric glioma, H3 G34-mutant * Diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype PSMA positive pathological stain (by immunohistochemistry) of baseline (pre-radiotherapy) resection or biopsy sample * Completion of standard of care therapy including surgery (for resectable tumors) and adjuvant EBRT for glioma * Patients must be on a dose of 4 mg or less of dexamethasone (or dexamethasone equivalent steroid) for 5 days prior to first planned dose of radiopharmaceutical * Age ≥ 18 * ECOG ≤ 2 * Serum creatinine level \< 1.5 x ULN or EGFR \> 60 mL/min * Liver laboratory values: ALT and AST ≤ 2.5 x ULN; Albumin \> 2 g/ dL; Bilirubin \< 3 X ULN * Normal organ and marrow function as defined as the following * To

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