NCT00298298终止1 期
L-Vax: A Feasibility Study Using a DNP-Modified Autologous Tumor Cell Vaccine as Therapy in Patients With Resectable Non-Small Cell Lung Cancer
AVAX Technologies4 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2006年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Cell-mediated immunity to autologous tumor cells.
研究概览
简要总结
To determine if a vaccine made from patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine
详细描述
Study Objectives: To study the toxicity, safety and delayed-type hypersensitivity (DTH) responses of DNP-modified autologous tumor cell vaccine (L-Vax) in patients with resectable NSCLC:
- To determine the tolerability and toxicity of L-Vax
- To determine whether L-Vax induces a DTH response to autologous, DNP-modified NSCLC cells of similar magnitude to responses observed with melanoma
- Determine whether L-Vax induces a DTH response to autologous unmodified NSCLC cells
- To determine whether the DTH responses to autologous, unmodified NSCLC cells that have been fixed with ethanol correlate with DTH responses to autologous, unmodified NSCLC cells that are not fixed
Study Population: Patients with resectable NSCLC whose therapeutic tumor surgery provides a mass, which yields adequate tumor, cells for vaccine preparation and DTH testing
Study Design: A Phase I/IIa double-blind, three-dose, single center study
Investigational Product: L-Vax: DNP-modified autologous NSCLC cell vaccine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented stage IA, IB, IIA, IIB or IIIA NSCLC that is completely resectable and does not require post-operative radiation therapy or peri-operative chemotherapy
- •Excision of the tumor and harvesting of tumor mass yielding adequate cells for vaccine manufacture and DTH testing
- •Successful preparation and lot release of vaccines and of DTH testing material containing DNP-modified tumor cells
- •Minimum of 3 and maximum of 8 weeks since the surgery
- •Expected survival of at least 6 months
- •Karnofsky performance status ³ 80
- •Signed informed consent
排除标准
- •Alkaline phosphatase > 2.5 x ULN
- •Total bilirubin > 2.0 mg/dL
- •Creatinine > 2.0 mg/dL
- •Hemoglobin < 10.0 g/dL
- •WBC < 3,000 /mm3
- •Platelet count < 100,000/mm3
- •Chemotherapy - pre-operative or post-operative (except as designated in protocol)
- •Radiation therapy to lung - pre-operative or post-operative
- •Any major field radiotherapy within 6 months prior to participation in the study
- •Immunotherapy (interferons, tumor necrosis factor, other cytokines [e.g., interleukins], biological response modifiers, or monoclonal antibodies) within 4 weeks prior to participation in the study
- •Prior splenectomy
- •Concurrent use of systemic steroids, except for the period of administration of the adjuvant chemotherapy, as per Section 8.6 (months 4-7)(Note: Topical steroid therapies [applied to the skin] are allowed, provided these are not applied to limbs injected with vaccine or skin test materials. Inhaled aerosol steroids are allowed.)
- •Concurrent use of immunosuppressive drugs, except for the period of administration of the adjuvant chemotherapy (months 4-7)
- •Concurrent use of antitubercular drugs (isoniazid, rifampin, streptomycin)
- •Other malignancy within 5 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ of the uterine cervix, or early stage (stage A or B1) prostate cancer
- •Concurrent autoimmune diseases, e.g., systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis
- •Concurrent medical condition that would preclude compliance or immunologic response to study treatment
- •Concurrent serious infection or other serious medical condition
- •Receipt of any investigational medication within 4 weeks prior to participation in the study
- •Pregnancy or lactation (serum b-human chorionic gonadotropin [b-HCG] test must be negative in fertile women at screening visit)
- •Active tuberculosis or a past history of tuberculosis
- •PPD positive (³ 5 mm to 5TU)
- •Known gentamicin sensitivity
- •Anergic, defined by the inability to make a DTH to at least one of the following: candida, mumps, tetanus or trichophyton (based, except for the period of administration of the adjuvant chemotherapy (months 4-7) upon availability)
- •Vaccine lot release failure
结局指标
主要结局
Cell-mediated immunity to autologous tumor cells.
时间窗: 3 months
Safety
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (4)
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