NCT00098917终止1 期
A Phase I Clinical Trial of Mature Autologous Dendritic Cells Loaded With Irradiated Autologous Tumor Cells for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who are undergoing surgery for stage IB, stage II, or stage IIIA non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of adjuvant autologous dendritic cells loaded with irradiated autologous tumor cells in patients with stage IB-IIIA non-small cell lung cancer undergoing resection.
- Determine the safety and tolerability of this vaccine in these patients.
Secondary
- Determine the feasibility of this vaccine in these patients.
- Determine vaccine-specific and antitumor immunity in patients treated with this vaccine.
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:
- •Diagnosis of non-small cell lung cancer
- •Clinical stage IB-IIIA disease
- •Candidate for surgical resection as primary treatment for tumor
- •Surgically resectable tumor ≥ 2.0 cm in diameter
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Platelet count ≥ 100,000/mm^3
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Hematocrit ≥ 30%
- •Hepatitis B surface antigen negative*
- •Hepatitis B core antigen negative*
- •Hepatitis C virus negative*
- •Bilirubin ≤ 2.0 mg/dL
- •AST and ALT ≤ 2 times upper limit of normal NOTE: *Screening performed only if liver enzymes are elevated
- •Creatinine ≤ 2.2 mg/dL
- •BUN ≤ 40 mg/dL
- •FEV_1 > 2.0 L (pre-resection) OR
- •Predicted post-resection FEV_1 > 1.0 L
- •No more than 2 chronic obstructive pulmonary disease exacerbations requiring > 2 weeks of oral steroids and/or hospitalization within the past year
- •Immunologic
- •Purified protein derivative (PPD) skin test negative
- •HIV-1 and HIV-2 negative
- •No acute infection, including any acute viral, bacterial, or fungal infection requiring specific therapy within the past 7 days
- •No allergy to study agents
- •No known autoimmune or collagen vascular disorder
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No underlying condition that would preclude study therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent anti-tumor necrosis factor agents
- •Chemotherapy
- •Standard adjuvant chemotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine
- •No concurrent cyclophosphamide
- •Endocrine therapy
- •No concurrent high-dose corticosteroids (e.g., > 10 mg of prednisone)
- •Concurrent corticosteroids for minor breathing exacerbations allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period
- •No concurrent corticosteroids within 48 hours before or after study vaccine administration
- •Radiotherapy
- •Standard adjuvant radiotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine
- •No prior organ allograft
- 另有 9 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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