NCT00045149已完成1 期
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen Specific T Cell Clones Targeting Cancer Testis Antigens for Patients With Metastatic Melanoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's white blood cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the safety and toxicity of cellular adoptive immunotherapy comprising autologous CD8+ cytotoxic T-lymphocyte clones targeting cancer-testis antigens in patients with metastatic melanoma.
- Determine the duration of in vivo persistence of this therapy in these patients.
Secondary
- Evaluate the antitumor effects of this therapy in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic melanoma
- •Stage IV disease
- •HLA-A1, -A2, and -A3 positive
- •MAGE-1 or -3 positive by histology
- •Bidimensionally measurable disease by palpation on clinical examination, x-ray, or CT scan
- •No CNS metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 80-100%
- •Life expectancy
- •More than 6 months
- •Hematopoietic
- •Not specified
- •Bilirubin ≤ 1.6 mg/dL
- •SGOT ≤ 3 times upper limit of normal
- •PT ≤ 1.5 times control
- •Creatinine ≤ 2.0 mg/dL
- •Calcium ≤ 12 mg/dL
- •Cardiovascular
- •No congestive heart failure
- •No clinically significant hypotension
- •No symptoms of coronary artery disease
- •No cardiac arrhythmias on electrocardiogram requiring drug therapy
- •Patients with prior cardiovascular disease or the presence of any of the above abnormalities undergo a cardiac evaluation, which may include a stress test and/or echocardiogram
- •No clinically significant pulmonary dysfunction by medical history or physical examination
- •FEV_1 ≥ 60% of normal
- •DLCO ≥ 55% (corrected for hemoglobin)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No retinitis or choroiditis
- •No active infections or oral temperature greater than 38.2 degrees Celsius within the past 72 hours
- •No systemic infection requiring chronic maintenance or suppressive therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No other concurrent immunotherapy (e.g., other interleukins, interferons, melanoma vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy)
- •Chemotherapy
- •At least 3 weeks since prior standard or experimental chemotherapy
- •1-2 courses of prior cytoreductive chemotherapy for bulky disease allowed
- •Endocrine therapy
- •No concurrent systemic steroids (except for toxicity management)
- •Radiotherapy
- •At least 3 weeks since prior radiotherapy
- •Not specified
- •At least 3 weeks since prior immunosuppressive therapy
- •No concurrent pentoxifylline
- •No other concurrent investigational agents
排除标准
- 未提供
研究者
研究点 (1)
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