NCT00062907Unknown1 期
Phase I Open-Label Dose Escalation Trial Evaluating The Safety And Immunogenicity Of Sequential Administration Of Recombinant DNA And Adenovirus Expressing L523S Protein In Patients With Early Stage Non-Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 9
- 试验地点
- 5
研究概览
简要总结
The purpose of this trial is to examine the safety and immunogenicity of a therapeutic vaccine regimen with recombinant DNA and adenovirus expressing L523S protein in patients with early stage non-small cell lung cancer. The vaccine regimen will consist of two fixed doses of recombinant DNA (pVAX/L523S) followed by two doses of recombinant adenovirus (Ad/L523S). The trial will evaluate the dose escalation of Ad/L523S through three cohorts of patients.
详细描述
The primary objective of the study is to evaluate the safety of the vaccine regimen administered as two doses of pVAX/L523S and two doses of Ad/L523S.
The secondary objectives of the study are:
- To provide initial evidence as to whether CD8+ and CD4+ T cell responses specific for L523S protein can be elicited by two doses of pVAX/L523S followed by two doses of Ad/L523S
- To provide initial evidence as to whether antibody responses specific for L523S protein can be elicited by two doses of pVAX/L523S followed by two doses of Ad/L523S
- To investigate the extent to which dose escalation of Ad/L523S affects the elicited immune response
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
- •Histologically and surgical confirmed diagnosis and stage of IB, IIA, or IIB non-small cell lung cancer (NSCLC) according to the Revised International System for Staging Lung Cancer
- •Primary surgical resection of lung cancer greater than or equal to 4 weeks and less than or equal to 3 years prior to the Day 0 visit
- •No evidence of disease by standard diagnostic tests
- •Chest X-ray and physical examination showing no active disease
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •WBC count greater than or equal to 3,000 cells/mm3 and ANC greater than or equal to 1,500 cells/mm3
- •Hemoglobin value greater than or equal to 10.0 g/dL and a platelet count greater than or equal to 125,000 cells/mm3
- •Adequate renal function (defined as serum creatinine <1.5 times the upper limit of normal for females and males)
- •Normal hepatic function (defined as serum bilirubin <1.5 times the upper limit of normal, AST <2.5 times the upper limit of normal and alkaline phosphatase <1.5 times the upper limit of normal)
- •Ability to understand and willingness to sign an IRB-approved written consent prior to study enrollment
- •Female patients must be greater than or equal to 60 years of age, or greater than or equal to 5 years amenorrhea or surgically sterile
- •Male patients who are capable of fathering a child and whose partners are capable of having a child must agree to use adequate contraception for 6 months after enrollment (for men or women-surgical sterilization; for women-hormonal contraceptives, vaginal ring or IUD)
- •Absolute CD4+ cell count of >200 cells/mm3
排除标准
- •Received pre- or post-operative radiotherapy
- •Received prior biologic, immunologic, or gene therapy for cancer
- •Received an investigational drug (new chemical entity) within three months of study entry
- •Received antibiotics within 2 weeks of Day 0 visit
- •Received systemic or inhaled corticosteroids or immunosuppressive therapy within 4 weeks of Day 0 visit (Use of topical corticosteroids and/or eye drops containing glucocorticosteroids is acceptable)
- •History of active autoimmune diseases such as, but not limited to, systemic lupus erythematosis, sarcoidosis, rheumatoid arthritis, glomerulonephritis, vasculitis, or inflammatory bowel disease
- •History of bleeding in stools and/or diarrhea within 4 weeks of Day 0 visit
- •History of anaphylaxis or severe allergic reaction to vaccines or unknown allergens
- •Received any commercial vaccine within 2 weeks of Day 0 visit
- •Received a major organ allograft
- •Current or previous diagnosis of paraneoplastic syndrome
- •Evidence of a clinically significant active pulmonary infection, emphysema, FeV1 less than or equal to 50% predicted, DLCO less than or equal to 50% predicted, pulse oximetry less than or equal to 92% at the time of study entry
- •Known to be HIV positive
- •Results of virology screening indicate positive serology for HCV (hepatitis C virus) and/or HBsAG (hepatitis B surface antigen). Positive serology for HBV antibodies is allowed.
- •History of other malignancies at other sites, except effectively treated non-melanoma skin cancers, superficial bladder cancer or carcinoma in situ of the cervix or an effectively treated malignancy that has been in remission for greater than 5 years and is highly likely to have been cured
- •Uncontrolled medical problems (neurological, cardiovascular, gastrointestinal, genitourinary or other illness) considered as unwarranted high risk for investigational new drug treatment
- •Patient is lactating
- •Staging classification of TX or NX or MX
- •Prior adjuvant chemotherapy within 8 weeks prior to the Day 0 visit
研究者
研究点 (5)
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