NCT00062036已完成1 期
Tumor Infiltrating Lymphocytes (TIL Cells) Transduced With An Interleukin-2 (SBIL-2) Gene Following The Administration Of A Nonmyeloablative But Lymphocyte Depleting Regimen in 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
- 33
- 试验地点
- 2
- 主要终点
- Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and fludarabine use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the gene for interleukin-2 into a person's tumor infiltrating lymphocytes may make the body build an immune response to kill tumor cells. Combining cyclophosphamide and fludarabine with gene-modified tumor cells may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gene-modified tumor infiltrating lymphocytes when given together with cyclophosphamide and fludarabine and to see how well they work in patients with metastatic melanoma (phase I is closed to accrual 3/29/06).
详细描述
OBJECTIVES:
Primary
- Determine the survival of patients with metastatic melanoma administered interleukin-2 gene-modified tumor infiltrating lymphocytes after cyclophosphamide and fludarabine.
- Compare survival results with prior Surgery Branch studies using adoptive cell therapy without the interleukin-2 retroviral vector (SBIL-2) gene.
Secondary
- Determine clinical tumor regression in patients administered interleukin-2 gene-modified TIL after cyclophosphamide and fludarabine followed by interleukin-2.
- Determine the toxicity profile 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of melanoma
- •Metastatic disease
- •Refractory to standard therapy including high-dose interleukin-2 (IL-2) therapy
- •Evaluable disease
- •Patients may enroll at the cell infusion stage provided they have tumor available for biopsy OR expandable SBIL-2-transduced tumor infiltrating lymphocytes available
- •Progressive disease during prior immunization to melanoma antigens or cellular therapy, with or without myeloablation, allowed
- •Symptomatic CNS lesions allowed provided immediate active treatment for symptomatic lesions has been completed
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count greater than 1,000/mm^3
- •WBC greater than 3,000/mm^3
- •Lymphocyte count greater than 500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 8.0 g/dL
- •No coagulation disorder
- •Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome)
- •AST/ALT less than 3 times upper limit of normal
- •Hepatitis B surface antigen negative
- •Hepatitis C virus negative
- •Creatinine no greater than 1.6 mg/dL
- •Cardiovascular
- •No myocardial infarction
- •No cardiac arrhythmias
- •No abnormal stress thallium or comparable test
- •LVEF > 45% and normal stress cardiac test in patients with the following criteria:
- •50 years old or greater
- •History of EKG abnormalities, symptoms of cardiac ischemia or arrhythmias
- •No major cardiovascular illness
- •No obstructive or restrictive pulmonary disease
- •No major respiratory illness
- •FEV_1 > 60% predicted in patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction
- •Immunologic
- •HIV negative
- •No prior severe immediate hypersensitivity reaction
- •No primary or secondary immunodeficiency
- •No active systemic infection
- •No concurrent opportunistic infection
- •No major immune system illness
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 months after study therapy
- •Must sign a durable power of attorney
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- 另有 9 项未显示
排除标准
- 未提供
结局指标
主要结局
Survival
次要结局
- Clinical tumor regression
- Toxicity profile
研究者
研究点 (2)
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