A Phase II Study of the Feasibility to Derive Autologous Vaccine (HSPPC-96) From Tumor Tissue for Clinical Administration in Patients With Resectable Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Agenus Inc.
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary goal of this trial is to determine if HSPPC-96 can be made from the tumor tissue of patients with resectable non-small cell lung cancer.
研究概览
简要总结
Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an autologous investigational vaccine (HSPPC-96) from the tumor tissue of patients with resectable non-small cell lung cancer.
Vaccine production will be attempted on all patients who undergo surgery and meet all inclusion/exclusion criteria.
详细描述
Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an autologous investigational vaccine (HSPPC-96) from the tumor tissue of patients with resectable non-small cell lung cancer.
All patients will undergo surgery to remove the tumor and will be followed for recurrence and overall survival.
The primary goal of this trial is to determine if HSPPC-96 can be made from the tumor tissue of patients with resectable non-small cell lung cancer.
The secondary goals are to further characterize the safety and efficacy profile, to evaluate disease recurrence in patients receiving, and to evaluate overall survival in patients receiving HSPPC-96.
HSPPC-96 is an investigational, immunotherapeutic agent made from an individual patient's own tumor, which is collected at the time of surgery. A portion of the tumor tissue is sent to Antigenics' manufacturing facility where it will undergo processing to create a vaccine. This vaccine may help the patient's immune system attack cancerous cells while leaving healthy cells alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Suspected non-small cell lung cancer, Stage IB, Stage II, or Stage IIIA
- •Tumor size > 3x3 cm or equivalent to a 9 cm² lesion
- •Scheduled surgery with curative intent
- •At least 18 years of age
- •Must not be pregnant or breast feeding
- •Agree to not receive any other investigative agent at any time while enrolled in this study
排除标准
- •Previous treatment for non-small cell lung cancer
- •Clinical signs or symptoms of brain metastases
- •History of immune suppression or autoimmune disorder
- •Severe active infection or other serious medical illness, that in the opinion of the Principal Investigator, would prevent study completion
- •Other malignancies in the past 5 years, except adequately treated in situ cervix carcinoma or non-melanoma skin cancer
结局指标
主要结局
The primary goal of this trial is to determine if HSPPC-96 can be made from the tumor tissue of patients with resectable non-small cell lung cancer.
次要结局
- The secondary goals are to further characterize the safety and efficacy profile, to evaluate disease recurrence in patients, and to evaluate overall survival in patients receiving HSPPC-96.