Actively Recruiting
LU-TARGET: A Phase 1 Study of Lutetium-177-PSMA-617 Adjuvant Radiotherapy for IDH Wild Type Gliomas Expressing PSMA Following Standard Treatment
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-06-04
20
Participants Needed
7
Research Sites
N/A
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
Researchers are evaluating the safety of a radiopharmaceutical therapy called 177Lu-PSMA-617 in people with IDH wild type glioma, a type of brain tumor. This phase 1 study focuses on patients with specific gliomas that express PSMA, aiming to understand the treatment's toxicity and disease progression after standard care. Participants will receive 177Lu-PSMA-617 for 2 to 6 doses, spaced about 4 weeks apart, given alongside standard oral Temozolomide chemotherapy. Temozolomide is started the night before each infusion of 177Lu-PSMA-617 for the first two cycles. After treatment, brain MRI scans will be done every 2 months, with additional 68Ga-PSMA-PET scans performed one month after the second dose and if the disease shows progression. Throughout the study, participants will complete quality of life questionnaires at baseline, and 6 and 12 months after treatment. Researchers will monitor toxicity up to 8 weeks after the first infusion and track progression-free survival for 2 years. The study involves regular imaging, lab tests, and clinical assessments to evaluate safety and disease status over time, with participation lasting according to these follow-up periods.
CONDITIONS
Brief 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 stain on baseline tumor tissue
- Completed standard treatment including surgery and adjuvant external beam radiotherapy
- On 4 mg or less of dexamethasone or equivalent steroid for 5 days before first dose
- Age 18 years or older
- ECOG performance status of 0 to 2
- Serum creatinine below 1.5 times upper limit of normal or estimated glomerular filtration rate above 60 mL/min
- Liver function tests: ALT and AST less than or equal to 2.5 times upper limit of normal, Albumin above 2 g/dL, Bilirubin below 3 times upper limit of normal
- Normal organ and marrow function with specified blood counts: white blood cells above 3.0 K/mcL, ANC above 1.5 K/mcL, platelets above 100 K/mcL, hemoglobin above 9 g/dL
- Adequate contraception before registration
- Ability to understand and sign informed consent
You will not qualify if you...
- Presence of any non-canonical IDH mutation other than R132H
- Tumor lesion within 5 mm of brainstem, optic chiasm, or optic nerves
- Previous treatment with bevacizumab for glioma
- Life expectancy less than 12 weeks
- Nonhealing wounds, ulcers, or bone fractures
- History of severe brain injury
- Inability to undergo sequential MRI evaluations
- Prior radiation therapy exceeding 25% of skeleton or prior exposure to certain radionuclides
- Current or prior malignancy that may interfere with safety or efficacy assessment
- Inability to tolerate PSMA PET/MR or PET/CT scans
- History of active viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Active infections such as HIV or viral hepatitis
- Participation in other investigational treatment protocols
- Known allergies or intolerances to study agents or 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 cycles of 28 days each
Participants begin taking Temozolomide orally on the first 5 days of each 28-day cycle, starting the evening before the first infusion of 177Lu-PSMA-617.
2 visits (in-person) corresponding to the first two cycles
Duration - 2 to 6 months depending on number of doses
Participants receive 2 to 6 doses of 177Lu-PSMA-617, spaced approximately 4 weeks apart, alongside adjuvant Temozolomide treatment.
Doses administered on Day 2 of the first two Temozolomide cycles; additional visits as per dosing schedule
Duration - 1 day
Approximately 4 weeks after the second cycle of radiopharmaceutical therapy, participants undergo post-treatment imaging with 68Ga-PSMA PET and MRI scans.
1 imaging visit (in-person)
Duration - Up to 12 months post treatment
Participants complete Quality of Life Questionnaires at baseline, 6 months, and 12 months post treatment. Routine brain MRIs are obtained every 2 months as part of standard care.
QOL surveys at baseline, 6 months, and 12 months; MRI every 2 months per standard care
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
T
Thomas Kaley, MD
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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