NCT00045357已完成1 期
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Metastatic Melanoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's white blood cells in the laboratory and 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 maximum tolerated dose of autologous CD4+ antigen-specific T-cells for cellular adoptive immunotherapy in patients with metastatic melanoma.
- Determine the safety and toxicity of this regimen in these patients.
- Determine the duration of in vivo persistence of adoptively transferred CD4+ antigen-specific T-cell clones in these patients.
Secondary
- Determine the antitumor effects of this regimen in these patients.
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 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
- •HLA type expressing one of the following class II alleles:
- •DRB1*0401
- •DRB1*0404
- •DRB1*1501
- •DPB1*0401
- •DPB1*0402
- •Tumor expresses tyrosinase
- •Tumor expressing NY-ESO-1 and are HLA type DP4, DP2, or DR7 allowed
- •No CNS metastases
- •Prior CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after treatment
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •More than 16 weeks
- •Hematopoietic
- •WBC greater than 4,000/mm^3
- •Absolute neutrophil count greater than 2,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hematocrit greater than 30%
- •SGOT no greater than 3 times upper limit of normal
- •INR no greater than 1.5 due to hepatic dysfunction
- •No significant hepatic dysfunction, defined as hepatic toxicity grade 2 or greater
- •Creatinine no greater than 2.0 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Calcium no greater than 12 mg/dL
- •Cardiovascular
- •No significant cardiac abnormalities*, defined by any 1 of the following:
- •Congestive heart failure
- •Clinically significant hypotension
- •Symptoms of coronary artery disease
- •Cardiac arrhythmias present on EKG requiring drug therapy NOTE: *Patients with a history of cardiovascular disease or any of the above abnormalities undergo a cardiac evaluation, including a cardiac stress test and/or echocardiogram
- •No clinically significant pulmonary dysfunction
- •FEV1 at least 1.0 L OR
- •FEV1 at least 60%
- •DLCO at least 55% (corrected for hemoglobin)
- •Immunologic
- •No acquired or hereditary immunodeficiency
- •No autoimmune disease
- •No active infection
- •No oral temperature greater than 38.2 degrees C within the past 72 hours
- •No systemic infection requiring chronic maintenance or suppressive therapy
- •HIV negative
- •No retinitis or choroiditis
- •No history of seizures
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study
- 另有 14 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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