A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha (SCH 721015, Ad.hIFN-a2b) Gene Transfer for Malignant Pleural Mesothelioma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- To analyze gene transfer with two does separated by three-day interval
研究概览
简要总结
This research will study how to activate the immune system by using gene transfer. Gene transfer involves inserting a specially designed gene into cancer cells. A gene is a part of the genetic code that instructs the cells of our bodies to produce specific compounds (proteins) important for the makeup or function of the cell. The study hypothesis is that repeated doses of SCH 721015 given over a three day interval would result in gene transfer.
详细描述
Ad.hIFN-α (SCH 721015, adenoviral-mediated interferon alpha) is a replication-defective recombinant adenoviral vector containing the human interferon-alpha (hIFN-alpha) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of Ad.hIFN-alpha injected into the pleural (intrapleural, IP) and given 4 days apart in subjects with pleural mesothelioma.
Subjects who meet eligibility will have a pleural catheter placed 2 weeks prior to the first dose. Subjects are then admitted to the research center on Days 1 and 4 for dosing and overnight observation. Subjects are then followed-up as outpatients for a total of 6 months. Radiographic evaluations are repeated on Day 64 and at 6 months. The pleural catheter is removed once it is not necessary.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •evidence of progressive disease after standard first line treatment of mesothelioma; OR patient has refused standard first line treatment of mesothelioma
- •evaluable disease
- •No radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic agents within 14 days prior to infusion of the IFN-α vector
- •Must have a pleural space involved with tumor accessible for pleural catheter insertion
- •FEV1> 1 liter or 40% of predicted value
- •Must have an anti-adenoviral neutralizing antibody titer equal to or less than 1:
- •This will be measured by the Penn Vector Core
排除标准
- •Presence of HIV or Hepatitis B infection
- •Use of concurrent systemic steroids, immunosuppressives, or any other medications that can directly or indirectly suppress the immune system
- •Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependence, significant chronic obstructive pulmonary disease (COPD), end stage liver or renal disease
- •Presence of untreated brain metastases
- •Prior bone marrow or stem cell transplants
研究组 & 干预措施
Dose Level 2
This is a dose de escalation.
干预措施: SCH 721015 (Biological)
Dose Level 1
干预措施: SCH 721015 (Biological)
结局指标
主要结局
To analyze gene transfer with two does separated by three-day interval
时间窗: After the first dose and at each visit until day 94
次要结局
未报告次要终点