LU-TARGET: A Phase 1 Study of Lutetium-177-PSMA-617 Adjuvant Radiotherapy for IDH Wild Type Gliomas Expressing PSMA Following Standard Treatment
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 14
- 主要终点
- Descriptively report the toxicity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Temozolomide (Drug)
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.
干预措施: 177Lu-PSMA-617 (Drug)
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.
干预措施: 68Ga-PSMA-PET scan/ MRI (Diagnostic Test)
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.
干预措施: Quality of Life Questionnaires (Behavioral)
结局指标
主要结局
Descriptively report the toxicity
时间窗: up to 8 weeks post first infusion
using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
次要结局
- Progression free survival (PFS)(2 years)