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Study of 177Lu-PSMA-617 for Gliomas

This study is looking into whether a treatment called 177Lu-PSMA-617 is safe for people with certain types of glioma (a type of brain tumor). You might be able to join if you have a confirmed diagnosis of a specific type of glioma, including diffuse astrocytoma, glioblastoma, diffuse midline glioma, or diffuse hemispheric glioma, and your tumor is IDH-wildtype (meaning it doesn't have a specific gene change). The study will also use a common chemotherapy drug called Temozolomide. Researchers will be looking at how safe 177Lu-PSMA-617 is by tracking any side effects for up to 8 weeks after the first dose. The current status of this study is unclear, and it plans to enroll 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. The phase of the study is not specified, and it aims to enroll 20 people.
What's involved
You would take Temozolomide orally for 5 days each 28-day cycle, with the first dose the evening before your first 177Lu-PSMA-617 infusion. 177Lu-PSMA-617 will be given 2-6 times, about 4 weeks apart. You will also have imaging scans (68Ga-PSMA PET and MRI) about 4 weeks after your second radiopharmaceutical therapy, and complete quality of life surveys at 6 and 12 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
The study will descriptively report toxicity for up to 8 weeks after the first infusion. Quality of life surveys will be conducted at 6 and 12 months post treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07223034

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~20 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Temozolomide177Lu-PSMA-61768Ga-PSMA-PET scan/ MRIQuality of Life Questionnaires

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Descriptively report the toxicity
Measured over up to 8 weeks post first infusion

Conditions

Glioma
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

Explore related trials

Diffuse AstrocytomaDiffuse Hemispheric GliomaDiffuse Midline GliomaDiffuse Pediatric-Type High Grade Glioma RTK2GlioblastomaFOLH1 GeneIDH1 GeneIDH1 wt AlleleRELAXIN 3

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Brandon Imber, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Brandon Imber, MD
[email protected]
631-212-6346
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Descriptively report the toxicityup to 8 weeks post first infusion

    using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.