VISTA: Valproic Acid, Irinotecan, and Simvastatin for Recurrent Glioma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Assessing Efficacy as Measured By Response Rate Of Valproic acid, Irinotecan, and Simvastatin in Recurrent Glioma
研究概览
简要总结
The goal of this clinical trial is to see if the combination of valproic acid, irinotecan, and simvastatin causes these tumors to stabilize or shrink, which is a sign that these combinations are effective against tumors in patients with recurrent glioblastoma and adults with recurrent IDH-mutated gliomas
详细描述
This is a prospective clinical trial in two cohorts of patients, adults with recurrent glioblastoma and adults with recurrent IDH-mutated gliomas.
The study evaluates the efficacy of valproic acid, irinotecan, and simvastatin in recurrent glioma by measuring response rate.
The study treatment is as follow: Study Treatment
- 21-day cycles
- D1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily
- D2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV
- D3-21 Continuous simvastatin starting at 40mg daily PO
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 98 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of glioblastoma or IDH-mutated glioma by WHO 2021 classification
- •For glioblastoma, at least one prior treatment, which needs to include temozolomide and/or radiation
- •For IDH-mutated glioma, prior treatment with both radiation and alkylating chemotherapy
- •Evidence of progression by RANO 2.0 criteria on MRI within last four weeks
- •At least 1 enhancing measurable lesion
排除标准
- •Use of an enzyme-inducing antiepileptic or other strong inducer of CYP3A4
- •Prior treatment with irinotecan
- •Prior use of valproic acid within 2 months
- •Anticancer treatment within 4 weeks, 6 weeks if nitrosourea
- •Active bacterial or fungal infection requiring systemic treatment
- •Pregnancy
- •Known mitochondrial disease
研究组 & 干预措施
Glioblastomas
Day1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily Day2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV Day3-21 Continuous simvastatin starting at 40mg daily PO
干预措施: Valproic Acid (VPA) (Drug)
IDH mutated gliomas
Day1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily Day2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV Day3-21 Continuous simvastatin starting at 40mg daily PO
干预措施: Valproic Acid (VPA) (Drug)
Glioblastomas
Day1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily Day2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV Day3-21 Continuous simvastatin starting at 40mg daily PO
干预措施: Simvastatin (Drug)
Glioblastomas
Day1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily Day2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV Day3-21 Continuous simvastatin starting at 40mg daily PO
干预措施: Irinotecan (Drug)
IDH mutated gliomas
Day1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily Day2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV Day3-21 Continuous simvastatin starting at 40mg daily PO
干预措施: Irinotecan (Drug)
IDH mutated gliomas
Day1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily Day2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV Day3-21 Continuous simvastatin starting at 40mg daily PO
干预措施: Simvastatin (Drug)
结局指标
主要结局
Assessing Efficacy as Measured By Response Rate Of Valproic acid, Irinotecan, and Simvastatin in Recurrent Glioma
时间窗: through study completion, an average of 6 months from start of treatment
The response is defined as a confirmed complete response (CR) or partial response (PR) defined by RANO 2.0. Response rate will be calculated as the number of observed response (PR or CR) divided by all treated subjects in the arm.
次要结局
- Assessing Safety and Adverse Event Rates Of Valproic Acid, Irinotecan, And Simvastatin in Recurrent Glioma(through end of study, average 9 months from start of treatment)