Actively Recruiting
A Study of 177Lu-PSMA-617 in People With Gliomas
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-11-04
20
Participants Needed
7
Research Sites
100 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of 177Lu-PSMA-617 in People With Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of WHO grade 2-4 glioma that is IDH1 R132H-wildtype, including diffuse astrocytoma, glioblastoma, diffuse midline glioma, diffuse hemispheric glioma, or diffuse pediatric-type high-grade glioma
- Positive PSMA staining on baseline tumor tissue
- Completed standard care therapy including surgery and adjuvant external beam radiation
- Taking 4 mg or less dexamethasone (or equivalent steroid) for 5 days prior to first radiopharmaceutical dose
- Age 18 years or older
- ECOG performance status 2 or less
- Serum creatinine less than 1.5 times upper limit of normal or estimated glomerular filtration rate above 60 mL/min
- Liver function: ALT and AST less than or equal to 2.5 times upper limit of normal; Albumin greater than 2 g/dL; Bilirubin less than 3 times upper limit of normal
- Normal organ and marrow function with white blood count above 3.0 K/mcL, absolute neutrophil count 1.5 K/mcL or higher, platelets 100 K/mcL or higher, and hemoglobin 9 g/dL or higher
- Use of adequate contraception before registration
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Presence of any non-canonical IDH mutations other than R132H
- Target lesion within 5 mm of brainstem, optic chiasm, or optic nerves
- Received bevacizumab as initial glioma treatment
- Life expectancy less than 12 weeks
- Nonhealing wound, ulcer, or bone fracture
- History of severe brain injury
- Unable to undergo sequential MRI evaluations
- Prior radiation therapy to more than 25% of skeleton or prior exposure to Radium223, Strontium89, or Samarium153
- Prior or concurrent malignancy that may affect safety or efficacy assessments
- Known or suspected grade II or higher chronic kidney disease
- Unable to tolerate PSMA PET/MR or PET/CT scans
- History of viral hepatitis or chronic liver disease with active symptoms
- History of pituitary or adrenal dysfunction
- Active infections such as HIV or viral hepatitis
- Any condition that would prevent study participation per investigator judgment
- Receipt of other investigational agents or concurrent treatment protocols
- Allergies or intolerances to 68Ga-PSMA-11, 177Lu-PSMA-617, or their components
- Current or planned pregnancy
- Refusal to comply with contraception requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
B
Brandon Imber, MD
CONTACT
T
Thomas Kaley, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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