NCT00091039已完成不适用
A Pilot Trial of a CEA/TRICOM-Based Vaccine in Combination With Combined Chemotherapy/Radiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in 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 vaccine therapy with chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This clinical trial is studying how well giving vaccine therapy together with paclitaxel, carboplatin, and radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed with surgery.
详细描述
OBJECTIVES:
Primary
- Determine the safety and feasibility of standard paclitaxel, carboplatin, and radiotherapy in combination with vaccinia-CEA-TRICOM vaccine, fowlpox-CEA-TRICOM vaccine, and recombinant fowlpox GM-CSF vaccine in patients with unresectable stage III non-small cell lung cancer.
Secondary
- Determine clinical response in patients treated with this regimen.
- Determine time to disease progression and overall median survival of patients treated with this regimen.
- Determine immunologic response in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-small cell lung cancer
- •Stage III (locally advanced) disease
- •Unresectable disease
- •Carcinoembryonic antigen (CEA)-positive (staining ≥ 20% of cells) tumor by immunohistochemistry
- •HLA-A2-positive
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Absolute lymphocyte count ≥ 600/mm^3
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin < 1.5 mg/dL
- •AST ≤ 2 times upper limit of normal
- •Hepatitis B and C negative
- •Creatinine normal OR
- •Creatinine clearance > 60 mL/min
- •Cardiovascular
- •No unstable or newly diagnosed angina pectoris
- •No myocardial infarction within the past 6 months
- •No New York Heart Association class II-IV congestive heart failure
- •Immunologic
- •HIV negative
- •No altered immune function
- •No active or history of eczema
- •No atopic dermatitis
- •No autoimmune disease, including any of the following:
- •Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
- •Systemic lupus erythematosus
- •Sjögren's syndrome
- •Scleroderma
- •Myasthenia gravis
- •Goodpasture's syndrome
- •Addison's disease
- •Hashimoto's thyroiditis
- •Active Graves' disease
- •Multiple sclerosis
- •No known history of allergy or serious reaction to prior vaccination with vaccina
- •No known allergy to eggs
- •No active or history of extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin condition
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 months after study participation
- •No history of seizures or encephalitis
- •Able to avoid close household contact with the following individuals for at least 3 weeks after vaccinia vaccination:
- 另有 34 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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