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

Официальное название

LU-TARGET: A Phase 1 Study of Lutetium-177-PSMA-617 Adjuvant Radiotherapy for IDH Wild Type Gliomas Expressing PSMA Following Standard Treatment

Обзор

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.

Вмешательства

• Препарат Temozolomide
  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.
• Препарат 177Lu-PSMA-617
  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.
• Диагностический тест 68Ga-PSMA-PET scan/ MRI
  Approximately 4 weeks after cycle 2 of radiopharmaceutical therapy (RPT), patients will undergo post-treatment imaging with 68Ga- PSMA PET and MRI
• Поведенческое Quality of Life Questionnaires
  baseline assessments, QOL surveys will be conducted with XeQOL and FACT-Br at 6 months and 12 months post treatment

Первичные конечные точки

• Descriptively report the toxicity [Срок оценки: up to 8 weeks post first infusion]

Вторичные конечные точки (1)

• Progression free survival (PFS) [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale

Идентификаторы

NCT: NCT07223034 · 25-169

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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