A Phase II Study of Elderly and Frail Patients With Newly Diagnosed or Recurrent Malignant Glioma Treated With Cesium-131 GammaTile® (ENDURANCE Trial)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of Participants who were able to receive the GammaTile Implant
研究概览
简要总结
This is a phase 2, open-label clinical trial determining feasibility, safety, and tolerability of GammaTile® in elderly or frail subjects with newly diagnosed or recurrent malignant gliomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Supratentorial
- •A bi-dimensionally measurable lesion of at least 10 mm, visible on two or more axial slices 5 mm apart.
- •The pre-operative tumor planned for resection is ≤ 7 cm in maximal dimension.
- •Tumor, which in the opinion of the enrolling neurosurgeon, is amenable to attempted gross total resection (GTR) or near total resection (NTR).
- •Anticipated GT placement (i.e., closest aspect of post resection tumor bed anticipated to receive GT placement) that is > 15mm from the optic chiasm or brainstem.
- •If multifocal, must be fully resectable in one operative bed. Surgical protocol will follow current institutional standards.
- •Able to receive 5-aminolevulinic acid (5-ALA, Gleolan) or other institutionally standard immunofluorescent-guidance such as fluorescein, prior to surgery to optimize GTR or NTR of enhancing tumor.
- •Karnofsky Performance Scale (KPS)
- •Elderly GBM: baseline KPS score of ≥
- •Frail GBM: baseline (pre-GBM diagnosis) is <70 and surgical management is expected to improve KPS to ≥ 60.
排除标准
- •Staged surgery planned (prior biopsy allowed).
- •Bilateral tumors, or multi-focal tumors that cannot be encompassed in one operative field.
- •Spinal tumors are excluded.
- •Enhancing extension into brainstem or thalamus, or significant invasion into the corpus callosum that would preclude a high likelihood of GTR or NTR.
- •Leptomeningeal disease not expected to be encompassed by the surgical resection.
- •Evidence of diffuse leptomeningeal disease that requires whole brain irradiation are excluded from this trial.
研究组 & 干预措施
Newly Diagnosed Elderly or Frail Glioblastoma
GammaTile®
干预措施: GammaTile® (Device)
Recurrent Elderly or Frail Glioblastoma
GammaTile®
干预措施: GammaTile® (Device)
Newly Diagnosed Frail (Non-GBM) Malignant Glioma
GammaTile®
干预措施: GammaTile® (Device)
Recurrent Frail (Non-GBM) Malignant Glioma
GammaTile®
干预措施: GammaTile® (Device)
结局指标
主要结局
Percentage of Participants who were able to receive the GammaTile Implant
时间窗: 28 days
Feasibility is defined by proportion of participants who were able to be treated with GammaTile
Number of Participants with Treatment-related Adverse Events
时间窗: 24 months
Safety and tolerability will be determined by the proportion, nature, and severity of treatment-related adverse events in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events (AEs) are reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, magnetic resonance imaging, and any other medically indicated assessments.
次要结局
- Progression-Free Survival (PFS)(24 months)
- Overall Survival (OS)(24 months)
研究者
Carlen Yuen
Assistant Professor
University of California, Irvine