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

RecruitingPhase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Conditions: Glioma, Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4), Glioblastoma, IDH-wildtype, Diffuse Midline Glioma, H3 K27-Altered, Diffuse Hemispheric Glioma, H3 G34-mutant

Interventions: Temozolomide, 177Lu-PSMA-617, 68Ga-PSMA-PET scan/ MRI, Quality of Life Questionnaires

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

  * 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
* 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

Locations (7)

Basking Ridge, New Jersey, United States
Middletown, New Jersey, United States
Montvale, New Jersey, United States
Commack, New York, United States
Harrison, New York, United States
New York, New York, United States
Uniondale, New York, United States