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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07223034
Phase
PHASE1
Status
Recruiting
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Conditions

  • Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4)
  • Diffuse Hemispheric Glioma, H3 G34-mutant
  • Diffuse Midline Glioma, H3 K27-Altered
  • Diffuse Pediatric-type High-grade Glioma, H3-wildtype and IDH-wildtype
  • Glioblastoma, IDH-wildtype
  • Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Temozolomide — DRUG
    Patients will begin taking Temozolomide orally on the first 5 days of each 28-day cycle. The first dose will be given the evening before the first infusion of 177Lu-PSMA- 617.
  • 177Lu-PSMA-617 — DRUG
    This agent will be given for 2-6 total doses, spaced 4 weeks (+/-1 week) apart. This will be administered on the 2nd day of the first two cycles of SOC adjuvant temozolomide.
  • 68Ga-PSMA-PET scan/ MRI — DIAGNOSTIC_TEST
    Approximately 4 weeks after cycle 2 of radiopharmaceutical therapy (RPT), patients will undergo post-treatment imaging with 68Ga- PSMA PET and MRI
  • Quality of Life Questionnaires — BEHAVIORAL
    baseline assessments, QOL surveys will be conducted with XeQOL and FACT-Br at 6 months and 12 months post treatment

Study Details

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.

Key Dates

Start date
Oct 27, 2025
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 177Lu-PSMA-617
    Patients will begin the first and second cycles of adjuvant Temozolomide (TMZ) the night before the first and second infusions of 177Lu-PSMA-617, respectively. Post-treatment, MRI of the brain will be obtained every 2 months, as per standard of care. A 68Ga-PSMA-PET scan will be performed with the MRI of the brain 1 month after the second cycle of 177Lu-PSMA-617 and again at evidence of disease progression.

Primary Outcome Measure

Descriptively report the toxicity [ Time Frame: up to 8 weeks post first infusion ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Brandon Imber, MD
631-212-6346
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Brandon Imber, MD
631-212-6346
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Brandon Imber, MD
631-212-6346
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Brandon Imber, MD
631-212-6346
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Brandon Imber, MD
631-212-6346
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Brandon Imber, MD
631-212-6346
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Brandon Imber, MD
631-212-6346

Find similar trials in Basking Ridge, NJ

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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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