A Phase 1 Ascending Dose Trial of Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered to Subjects at the Time of Resection for Recurrent High Grade Glioma & Followed by Treatment With Toca FC, Extended-Release 5-FC
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Tocagen Inc.
- 入组人数
- 58
- 试验地点
- 8
- 主要终点
- Dose Limiting Toxicities
研究概览
简要总结
This is a multicenter study evaluating the safety and tolerability of increasing doses of Toca 511, a retroviral replicating vector, injected into the resection cavity of patients with Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their tumor. Approximately 6 weeks after injection of Toca 511, patients will begin an oral courses of Toca FC, an antifungal agent. These one week courses of Toca FC will be repeated during the approximately 30 week study. Two separate cohorts of patients treated with Toca 511 and Toca FC will also be evaluated with either of the following standard treatments for glioma: lomustine or bevacizumab. After completion of this study, all patients will be eligible for enrollment and encouraged to enter a long-term continuation protocol that enables additional Toca FC treatment cycles to be given, as well as permits the collection of long-term safety and survival data.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Arm
Toca 511 vector/Toca FC prodrug
干预措施: Toca 511 vector (Biological)
Single Arm
Toca 511 vector/Toca FC prodrug
干预措施: Toca FC (Drug)
结局指标
主要结局
Dose Limiting Toxicities
时间窗: 2 months
Excluding nausea, vomiting and fatigue, any Grade 3 or higher non-hematologic toxicity or any Grade 4 or higher hematologic toxicity, felt to be related to Toca 511 or the Toca 511/Toca FC combination.
次要结局
- Overall Survival of Subjects(Overall survival, Overall survival at 6 months (OS6), 9 months (OS9), and 12 months (OS12))
- Progression Free Survival (PFS) of Subjects(PFS of subjects at 6 months (PFS-6))
