Clinical Trial Finder

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.

• - Total white blood count > 3.0 K/mcL.

• - ANC ≥ 1.5 K/mcL.

• - Platelets ≥ 100 K/mcL.

• - Hemoglobin ≥ 9 g/dL.

• - Adequate contraception prior to registration (see section 9.0) - Ability to understand, and willingness to sign the informed consent.

Exclusion Criteria:

• - 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.

• - History of severe brain injury.

• - Patient not eligible for sequential MRI evaluations.

• - Patients with prior RT to > 25% of the skeleton or prior exposure to prior Radium223, Strontium89 or Samarium153 containing compounds.

• - Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.

• - Patients with known or suspected history of grade II or higher chronic kidney disease (CKD) - Unable to tolerate the PSMA PET/MR or PSMA PET/CT.

• - History of viral hepatitis or chronic liver disease with active symptoms.

• - History of pituitary or adrenal dysfunction.

• - Previously diagnosed active infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis) - Any condition that in the opinion of the investigator, would preclude participation in this study.

• - Receipt of any other investigational agents or participation in a concurrent treatment protocol.

• - Known allergies, hypersensitivities, or intolerance to 68Ga-PSMA-11/177Lu-PSMA-617 or its inactive compounding components.

• - Current or planned pregnancy.

Arms

Interventions