A Pilot Study to Evaluate the Immunogenic Effects of Window-of-Opportunity Fractionated Stereotactic Radiotherapy Combined With Atezolizumab for Patients With Newly Diagnosed WHO CNS Grade 4 Glioma (Glioblastoma Multiforme)
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of participants who progress/relapse after surgical resection
研究概览
简要总结
This is a single-arm pilot study that will recruit 12 patients with newly diagnosed Glioblastoma, a malignant brain tumor with a poor prognosis. Patients will be treated with fractionated stereotactic radiotherapy (FSRT) for 2 weeks, in addition to two doses of Atezolizumab (Tecentriq), an FDA approved PD- L1 inhibitor drug, 840 mg IV, at the beginning and at the end of the two-week time period, concomitantly with FSRT. After this initial two weeks treatment the patients will undergo craniotomy and maximal safe resection as per normal care for a GB. After surgery patients will follow the normal care for glioblastoma in addition to Atezolizumab 840 mg IV q2 weeks for the duration of adjuvant treatment.
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
- •Diagnosis of glioblastoma multiforme WHO Grade IV
- •The patient is a surgical candidate, with the surgical intent for a > 80% resection of the lesion
- •Negative pregnancy test
- •ECOG status <= 2
- •Tumor volume <= 3.5 cm
- •Adequate organ function
- •Negative for infectious disease (human immunodeficiency virus, Hepatitis B Virus, Hepatitis C Virus, tubercolosis)
排除标准
- •Patient already underwent surgical total or partial tumor resection, or radiation therapy
- •Presence of leptomeningeal disease, gliomatosis cerebri, multifocal disease, bilateral cerebral hemisphere involvement ("butterfly" gliomas)
- •Patients at increased risk of neurologic decompensation
- •Continued use of high dose intravenous or oral corticosteroids, or > 8milligrams per day of systemic dexamethasone
- •Uncontrolled tumor-related pain
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- •Uncontrolled or symptomatic hypercalcemia
- •History of autoimmune disease or immune deficiency
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- •Significant cardiovascular disease
- •History of other malignancy within 1 year prior to screening
- •Severe infection within 4 weeks prior to initiation of study treatment
- •History of allogeneic stem cell or organ transplant
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies
- •Treatment with systemic immunostimulatory agents
- •Treatment with systemic immunosuppressive medication
结局指标
主要结局
Number of participants who progress/relapse after surgical resection
时间窗: 2 years
Assess the efficacy of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: 30 days after the last dose of atezolizumab
Assess the safety of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme
次要结局
未报告次要终点
研究者
Alexander Stessin
Professor of Medicine
Stony Brook University