Phase I Pilot Study to Evaluate the Anti-glioblastoma Effect of S-Gboxin in Standard Treatment of Glioblastoma/Diffuse Midline Glioma and Response to Treatment (Regardless of Mutation Status)
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Brain tumor metabolism as measured by PET and MRI
研究概览
简要总结
The objective of this pilot study is to evaluate the efficacy of adding S-Gboxin to standard RT/TMZ treatment protocols in patients with glioblastoma multiforme (GBM) or midline glioma (DMG), regardless of their mutation status
详细描述
This is a pilot study to evaluate the efficacy of adding the mitochondrial oxidative phosphorylation inhibitor S-Gboxin (OXPHOS) to standard treatment for glioblastoma multiforme or glioma.
Subjects will start oral S-gboxin orally twice daily and will evaluate the patients and vital status if they tolerate this dose at 3, 7and 15 days after initiation.
Patients will undergo MRI scans before treatment and then at multiple time points during their participation in this Clinical Trial to monitor early tumor response to treatment ( MRI dates will be scheduled by the clinical trial coordinator)
Peripheral blood samples will be collected at baseline, days 1-7-15-28-36-72 to compare biological indicators of treatment response. In some cases, circulating tumor cells (CTCs) will be monitored by real-time qRT-PCR to correlate with clinical data.
Patients will also be assessed for the side effects they experience. Disease-free and overall survival outcomes will be recorded.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of Glioblastoma according to RANO criteria by contrast-enhanced MRI or PET-CT (including diffuse midline glioma, gliosarcoma or giant cell glioblastoma), relapse or disease progression
- •patient is able to understand and give consent to participate in the study
- •Karnofsky performance score ≥ 60
- •women of childbearing potential must have a negative pregnancy test result no later than 7 days before registration
排除标准
- •known allergies
- •active treatment on annotner clinical trial
- •inability to complete with protocol or studio procedures.
研究组 & 干预措施
Patients will be offered 4 courses of Gboxin during (or without) standard treatment.
Patients will be offered 4 courses of S-Gboxin during standard treatment. Each course (18 days) consists of twice daily intake of S-Gboxin for 14 days and four days of rest. Each dose of S-Gboxin is packed in a gelatin capsule with a bandage and applied markings.
干预措施: S-Gboxin (Biological)
结局指标
主要结局
Brain tumor metabolism as measured by PET and MRI
时间窗: Up to 6 month
The standardized uptake value (SUV) of HGG will be measured. SUV is a standard PET measurement. MRI with contrast will evaluate the change in tumor size before and after therapy S-Gboxin
次要结局
- Overall survival (OS)(Up to 12 month)
- Incidence of adverse events graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version (v)4.03(Up to 1 month after last dose of S-Gboxin)