NCT00079144已完成2 期
Treatment Of Patients With Metastatic Melanoma Using Nonmyeloablative But Lymphocyte Depleting Regimen Followed By The Administration Of In Vitro Sensitized Lymphocytes Reactive With ESO-1 Antigen
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Clinical tumor regression
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Treating a person's lymphocytes in the laboratory and reinfusing them may replace immune cells destroyed by chemotherapy. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Giving a vaccine with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells.
PURPOSE: This phase II trial is studying how well lymphocyte-depleting nonmyeloablative (not damaging to bone marrow) chemotherapy followed by autologous lymphocyte infusion, peptide vaccine plus Montanide ISA-51, and interleukin-2 works in treating patients with metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the clinical tumor regression in patients with metastatic melanoma treated with a lymphocyte-depleting nonmyeloablative preparative chemotherapy regimen followed by autologous lymphocyte infusion, ESO-1 peptide vaccination comprising ESO-1:157-165 (165V) and Montanide ISA-51, and interleukin-2.
Secondary
- Determine the survival of the infused lymphocytes in patients treated with this regimen.
- Determine the long-term immune status of patients treated with this regimen.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of metastatic melanoma that is refractory to standard therapy (including high-dose interleukin-2)
- •Measurable disease
- •HLA-A*0201 positive
- •Epstein-Barr virus positive
- •ESO-1-expressing disease by reverse transcription polymerase chain reaction amplified tissue OR presence of ESO-1 serum antibody
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin > 8.0 g/dL
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •AST and ALT < 3 times upper limit of normal
- •Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL for patients with Gilbert's syndrome)
- •No coagulation disorders
- •Creatinine ≤ 2.0 mg/dL
- •Cardiovascular
- •No prior myocardial infarction
- •No major cardiovascular illness by stress thallium or comparable test
- •No cardiac arrhythmias
- •LVEF ≥ 45%
- •Normal cardiac stress test required for the following conditions:
- •Prior EKG abnormalities
- •Symptoms of cardiac ischemia
- •Arrhythmias
- •Age 50 and over
- •FEV_1 > 60% of predicted (for patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction)
- •No obstructive or restrictive pulmonary disease
- •No other major respiratory illness
- •Immunologic
- •HIV negative
- •No active systemic infection
- •No opportunistic infection
- •No major immune system illness
- •No form of primary or secondary immunodeficiency
- •No known hypersensitivity to study agents
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 4 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •Prior ESO-1-based vaccination allowed
- •Chemotherapy
- •At least 6 weeks since prior nitrosoureas and recovered
- 另有 6 项未显示
排除标准
- 未提供
结局指标
主要结局
Clinical tumor regression
次要结局
- Long-term immune status
- Survival of infused lymphocytes
研究者
研究点 (2)
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