Phase II Trial Of Surgery With Perioperative RPR/INGN 201 (Ad5CMV-p53) Gene Therapy Followed By Chemoradiotherapy For Advanced, Resectable Squamous Cell Carcinoma Of The Oral Cavity, Oropharynx, Larynx, and Pharynx
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- Feasibility
研究概览
简要总结
RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy with the p53 gene may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gene therapy plus surgery followed by cisplatin and radiation therapy in treating patients who have newly diagnosed resectable stage III or stage IV cancer of the mouth or throat.
详细描述
OBJECTIVES:
- Determine the feasibility of treating patients with newly diagnosed resectable stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx with surgery and Ad5CMV-p53 gene followed by cisplatin and radiotherapy.
- Determine the progression-free survival, local control, and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in this patient population.
OUTLINE: This is a multicenter study.
Patients undergo surgical resection and receive an intraoperative Ad5CMV-p53 gene injection into the resection bed and into the deep soft tissue bed of the cervical level with nodal metastasis. Patients also receive a third intraoperative Ad5CMV-p53 gene injection into the neck dissection bed, where it is allowed to sit in place for 10 minutes.
Within 48-72 hours after surgery, patients receive a postoperative Ad5CMV-p53 gene injection into each of two drainage catheters next to the mucosal suture line and neck dissection bed, where it is allowed to sit in place for 2 hours.
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 —（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
surgery with INGN 201 followed by chemo/RT
intraoperative and postoperative injections of INGN 201 into the tumor bed, followed by cisplatin and radiation therapy
干预措施: Ad5CMV-p53 gene (Biological)
surgery with INGN 201 followed by chemo/RT
intraoperative and postoperative injections of INGN 201 into the tumor bed, followed by cisplatin and radiation therapy
干预措施: cisplatin (Drug)
surgery with INGN 201 followed by chemo/RT
intraoperative and postoperative injections of INGN 201 into the tumor bed, followed by cisplatin and radiation therapy
干预措施: conventional surgery (Procedure)
surgery with INGN 201 followed by chemo/RT
intraoperative and postoperative injections of INGN 201 into the tumor bed, followed by cisplatin and radiation therapy
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Feasibility
时间窗: 1 year
accrual rate and percentage of patients successfully receiving the required doses of INGN 201
次要结局
- Progression-free survival from time of registration until disease progression(two years)