NCT00317759已完成1 期
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 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. Fludarabine may help the immune system kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8+ antigen-specific cytotoxic T-lymphocyte (CTL) clones after fludarabine in patients with stage IV melanoma.
- Determine the duration of in vivo persistence of these CTL clones in these patients.
Secondary
- Determine the antitumor effect of this regimen 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-A2 or -A3-expressing disease
- •Bidimensionally measurable residual disease by palpation or radiographic imaging (e.g., x-ray or CT scan)
- •No CNS metastases
- •Previously treated CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after completion of therapy
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 80-100%
- •Life expectancy
- •More than 6 months
- •Hematopoietic
- •Platelet count > 100,000/mm^3
- •Absolute neutrophil count > 2,000/mm^3
- •SGOT no greater than 3 times upper limit of normal
- •Bilirubin no greater than 1.6 mg/dL
- •INR no greater than 1.5 times normal
- •Creatinine no greater than 2.0 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular
- •No congestive heart failure
- •No clinically significant hypotension
- •No symptoms of coronary artery disease
- •No cardiac arrhythmia by EKG requiring drug therapy
- •No clinically significant pulmonary dysfunction
- •FEV_1 at least 1.0 L*
- •DLCO at least 45%* NOTE: *For patients with a history of pulmonary dysfunction
- •Immunologic
- •No active infection
- •No oral temperature greater than 38.2°C within the past 48 hours
- •No systemic infection requiring chronic maintenance or suppressive therapy
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulins, expanded polyclonal tumor-infiltrating lymphocytes, or lymphokine-activated killer therapy)
- •Chemotherapy
- •At least 3 weeks since prior chemotherapy (standard or experimental)
- •Endocrine therapy
- •No concurrent steroids
- •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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