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NCT07223034 | RECRUITING | Glioma

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

Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease

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

Intervention/treatment

Temozolomide

177Lu-PSMA-617

68Ga-PSMA-PET scan/ MRI

Quality of Life Questionnaires

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : LU-TARGET: A Phase 1 Study of Lutetium-177-PSMA-617 Adjuvant Radiotherapy for IDH Wild Type Gliomas Expressing PSMA Following Standard Treatment
Actual Study Start Date : 2025-10-27
Estimated Primary Completion Date : 2027-10
Estimated Study Completion Date : 2027-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • * 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
A Study of 177Lu-PSMA-617 in People With Gliomas

Location Details

NCT07223034

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553