NCT00496535已完成1 期
A Phase I/II Safety, Tolerability, and "Proof of Concept" Study of TNFerade™ Biologic in Combination With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) for Patients With Unresectable Recurrent Head and Neck Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- GenVec
- 试验地点
- 2
- 主要终点
- locoregional control at 24 months
研究概览
简要总结
The primary objective of the first phase is to determine the safety, the maximum tolerated dose (MTD) and dose-limiting toxicity of TNFerade in combination with the previously studied combination of Fluorouracil (5FU), Hydroxyurea (HU) and standard daily radiotherapy in patients with recurrent head and neck cancer (RHNC). All chemoradiotherapy is administered on a "week-on/week-off" schedule. The primary objective of the second phase II is to determine the locoregional control rate at 24 months.
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
- •Head and neck cancer
- •Patients must have a locoregional tumor amenable to reirradiation with curative intent.
- •disease, or the majority of disease, should be accessible to injection via direct intratumoral injection
- •Life expectancy of greater than 12 weeks
- •Age > 18 years
- •ECOG performance status 0-1
排除标准
- •Metastatic disease
- •History of malignancy (other than head and neck cancer) in the last 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer, or localized early stage prostate cancer, with patients continually disease free, or cancers that are not felt to influence treatment for head and neck cancer and life expectancy of patient
- •Patients may not be receiving any other investigational agents currently or within the 4 weeks prior to study Day 1
- •Active infection of any type
- •Chronic treatment for greater than 6 months with steroids
- •Pregnant or lactating women
- •Patients with known history of cerebral vascular disease; stroke or TIA within the last 6 months
- •Patients with history of documented thrombosis (PE or DVT), or known coagulopathy or thrombophilia, or evidence of DVT / thromboembolic event upon enrollment
- •Patients receiving hormone replacement therapy or hormonal contraceptives within two weeks of day 1
- •Patients who have undergone surgery within the last 1 month prior to day 1
- •Patients with active carotid artery involvement or status post carotid artery graft / stenting
结局指标
主要结局
locoregional control at 24 months
次要结局
- Locoregional control at 3, 6 and 12 months, as well as tumor response rate, progression-free survival at 3, 6, 12 and 24 months, and the rate of metastases at 3, 6, 12 and 24 months will also be assessed.
研究者
研究点 (2)
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