A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and
研究概览
简要总结
This Phase I study will evaluate the safety of two doses of BG00001 at different doses and intervals. Eligible subjects will have:
- malignant pleural mesothelioma, or
- pleural effusions who have progressed through at least one prior therapy or have refused therapy
BG00001 is given twice through a catheter in the pleural space.
详细描述
Ad.hIFN-β (BG00001) is a replication-defective recombinant adenoviral vector containing the human interferon-beta (hIFN-β) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of intrapleural (IP) Ad.hIFN-β in subjects with pleural malignancies either metastatic or pleural mesothelioma.
Five dose levels will be studied:
- Dose levels 1, 2, and 3 will be given on Days 1 and 15
- Dose levels 4 and 5 will be given on Days 1 and 8
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
- •must have malignant pleural effusion from mesothelioma or metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma
- •must have evaluable disease
- •must have ECOG performance status of 2
- •must have pleural space involved with tumor accessible for pleural catheter
- •must have FEV1 > 1 liter or 40% of predicted value
- •must have completed radiotherapy and/or treatment with chemotherapy, cytotoxic, or immunologic agents 4 weeks prior to dosing with BG00001
- •concurrent Tarceva is allowed if patients has been on a stable dose for at least three months and has not had serious adverse events
- •patients on stable dose of hormone may continue use of hormone
- •patients on stable dose of Tarceva for 3 months and without complications may remain on Tarceva
排除标准
- •malignant pleural effusions secondary to lymphoma
- •rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation
- •untreated brain metastases
- •use of concurrent systemic steroids or immunosuppressants
研究组 & 干预措施
Dose level 4
干预措施: Adenoviral-mediated Interferon-beta (Biological)
Dose level 5
干预措施: Adenoviral-mediated Interferon-beta (Biological)
Dose Level 2
On Days 1 and 15
干预措施: SCH 721015 (Biological)
Dose Level 1
on Days 1 and 15
干预措施: SCH 721015 (Biological)
Dose level 5
干预措施: SCH 721015 (Biological)
Dose level 4
干预措施: SCH 721015 (Biological)
Dose Level 3
On Days 1 and 15
干预措施: SCH 721015 (Biological)
结局指标
主要结局
To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and
时间窗: Through Day 85
次要结局
- To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation,(Through Day 85)
- and to assess, in a preliminary way, efficacy via tumor regression, time to progression and survival.(15 years or until subject dies, whichever comes first)