A Phase I-II Trial Using Dendritic Cells Transduced With An Adenoviral Vector Containing The p53 Gene To Immunize Patients With Extensive Stage Small Cell Lung Cancer After Standard Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Rate of Toxicity of the Ad-p53 DC Vaccine
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Combining vaccine therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by adenovirus p53 vaccine therapy in treating patients who have extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of autologous dendritic cell-adenovirus p53 vaccine, administered after standard chemotherapy, in patients with extensive stage small cell lung cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the development of an anti-p53-specific immune response in these patients after treatment with this regimen.
- Determine the tumor response rate, time to progression, and overall survival of patients treated with this regimen.
- Determine the frequency of anti-adenovirus immune responses in these patients after treatment with this regimen.
OUTLINE: This is a dose-escalation study of autologous dendritic cell-adenovirus p53 vaccine.
Patients undergo leukapheresis and dendritic cells are cultured. Adenovirus carrying p53 gene particles are added to the dendritic cells to make the vaccine. Leukapheresis is performed before chemotherapy or 8 weeks after the last dose of chemotherapy if the patient has already started chemotherapy.
Patients receive standard chemotherapy before receiving the vaccine. The recommended regimen is carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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
Vaccine Administration
• Phase I: Beginning 9 weeks after completion of chemotherapy, patients receive autologous dendritic cell-adenovirus p53 vaccine subcutaneously (SC) on days 1, 14, and 28. Patients without PD may undergo repeat leukapheresis on day 49. Patients receive vaccine SC again on days 56, 84, and 112 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of autologous dendritic cell-adenovirus p53 vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
• Phase II: Patients receive autologous dendritic cell-adenovirus p53 vaccine at the MTD determined in phase I.
干预措施: Autologous dendritic cell-adenovirus p53 vaccine (Biological)
Vaccine Administration
• Phase I: Beginning 9 weeks after completion of chemotherapy, patients receive autologous dendritic cell-adenovirus p53 vaccine subcutaneously (SC) on days 1, 14, and 28. Patients without PD may undergo repeat leukapheresis on day 49. Patients receive vaccine SC again on days 56, 84, and 112 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of autologous dendritic cell-adenovirus p53 vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
• Phase II: Patients receive autologous dendritic cell-adenovirus p53 vaccine at the MTD determined in phase I.
干预措施: Carboplatin (Drug)
Vaccine Administration
• Phase I: Beginning 9 weeks after completion of chemotherapy, patients receive autologous dendritic cell-adenovirus p53 vaccine subcutaneously (SC) on days 1, 14, and 28. Patients without PD may undergo repeat leukapheresis on day 49. Patients receive vaccine SC again on days 56, 84, and 112 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of autologous dendritic cell-adenovirus p53 vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
• Phase II: Patients receive autologous dendritic cell-adenovirus p53 vaccine at the MTD determined in phase I.
干预措施: Etoposide (Drug)
结局指标
主要结局
Rate of Toxicity of the Ad-p53 DC Vaccine
时间窗: 4 years
To evaluate the toxicity of the Ad-p53 dendritic cell (DC) vaccine. While there is no expected toxicity from the Ad-p53 vaccine, there may be unforeseen adverse effects. Patients will be monitored for toxicity, particularly for evidence of autoimmunity. Complete blood counts (CBCs) to monitor for hematologic toxicity, serum creatinine to monitor for renal toxicity, liver function tests (LFTs) to monitor for hepatic toxicity, and a standard clinical toxicity will be performed every other week throughout the period of immunization. In addition, a medical history and physical examination will be performed on a monthly basis.
次要结局
未报告次要终点