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

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

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
* Refusal to comply with detailed contraception requirements

Conditions7

Locations7 sites

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