NCT00496236已完成1 期
A Phase I/II Safety, Tolerability and "Proof of Concept" Study of Radiotherapy, Cetuximab, and Intratumoral Injections of TNFerade™ Biologic (AdGVEGR.TNF.11D) for Elderly or Frail Patients or Intermediate Stage Patients With 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
- The maximum tolerated dose established in the Phase I (dose-finding) portion of the study will be used to assess the investigational drug's ability to enhance clinical outcome. The primary endpoint being locoregional control rate at 24 months.
研究概览
简要总结
This study is looking at the safety and tolerability of TNFeradeä Biologic combined with conventional once daily radiation therapy in elderly or frail patients with new onset locally advanced head and neck tumors.
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
- •Age 70 or older with an ECOG performance status 0-2,or
- •Patients > 18 years of age with ECOG performance status of 2 or greater, or
- •Patients > 18 years of age unsuitable for concurrent chemotherapy or surgery due to:
- •Renal failure, or
- •Severe cardiopulmonary disease, or
- •Other end-organ dysfunction that precludes the use of chemotherapy but does not preclude the administration of TNFerade™ Biologic or cetuximab
- •Tumor that is unresectable or inoperable and not amenable to regular concurrent chemoradiotherapy
- •Patients > 18 years of age with intermediate stage disease, stages II-III (T2-T3, N0-1MO) carcinoma of the head and neck, including oral cavity, pharynx larynx, paranasal sinuses and cervical esophagus. Selected patients with stage IV disease (T4N0-1M0) will also be considered for enrollment. Therapy is given with curative intent.
- •Disease should be clinically accessible (measurable or evaluable) to keep injection via direct intratumoral injection
- •Informed consent
排除标准
- •History of malignancy 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
- •Overt systemic metastatic disease
- •Previous radiation or chemotherapy for malignancy of the head and neck
- •Clinical evidence of active infection of any type
- •pregnant or lactating women
- •Experimental medications within the last 4 weeks prior to Day 1
- •Chronic treatment for greater than 6 months with steroids at doses above 10 mg/day prednisone (or equivalent)
- •Patients receiving hormone replacement therapy or hormonal contraceptives within 2 weeks of day 1
- •Patients who have undergone surgery within the last 1 month
- •Allergic reaction to cetuximab
结局指标
主要结局
The maximum tolerated dose established in the Phase I (dose-finding) portion of the study will be used to assess the investigational drug's ability to enhance clinical outcome. The primary endpoint being locoregional control rate at 24 months.
次要结局
- Locoregional control at 3,6, and 12 months, objective response rate, progression-free survival at 3,6,12, and 24 months, and the rate of distal metastases at 3,6, 12 and 24 months will also be assessed.
研究者
研究点 (2)
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