NCT00138229终止2 期
Phase II Trial Using Aldesleukin (IL-2) Following a Lymphodepleting Chemotherapy and Reinfusion of Autologous Lymphocytes Depleted of T Regulatory Lymphocytes in Metastatic Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Tumor regression
研究概览
简要总结
RATIONALE: An infusion of a patient's lymphocytes that have been treated in the laboratory to remove certain immune cells may be an effective treatment for melanoma. Drugs, such as cyclophosphamide and fludarabine, may suppress the immune system so that the patient's immune cells allow the infused lymphocytes to work. Interleukin-2 may help the lymphocytes kill more tumor cells when they are put back in the body. Giving cyclophosphamide and fludarabine followed by an autologous lymphocyte infusion and interleukin-2 may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine followed by an autologous lymphocyte infusion and interleukin-2 works in treating patients with refractory or recurrent melanoma.
详细描述
OBJECTIVES:
Primary
- Determine tumor regression in patients with metastatic melanoma treated with nonmyeloablative lymphodepleting chemotherapy comprising cyclophosphamide and fludarabine followed by autologous CD25-positive-T-regulatory-cell-depleted lymphocyte reinfusion and high-dose interleukin-2.
Secondary
- Determine the rate of repopulation of CD25-positive T-regulatory cells in patients treated with this regimen.
- Determine the toxicity 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 —（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
- •Measurable disease
- •HLA-A2 negative disease
- •Disease did not respond to OR recurred after completion of prior high-dose interleukin-2 (IL-2)
- •Eligible to receive high-dose IL-2
- •No tumor reactive cells available for cell transfer therapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin > 8.0 g/dL
- •No coagulation disorders
- •ALT and AST < 3 times upper limit of normal
- •Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL if due to Gilbert's syndrome)
- •Hepatitis B surface antigen negative
- •Hepatitis C antigen negative
- •Creatinine ≤ 2.0 mg/dL
- •No renal failure requiring dialysis due to toxic effects of prior IL-2 administration
- •Cardiovascular
- •No myocardial infarction
- •No cardiac arrhythmias
- •No other major cardiovascular illness as evidenced by a positive stress thallium or comparable test
- •Normal cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram) AND LVEF ≥ 45% (for patients ≥ 50 years of age or who have a history of EKG abnormalities, symptoms of cardiac ischemia, or arrhythmias)
- •No obstructive or restrictive pulmonary disease
- •No other major respiratory illness
- •FEV_1 ≥ 60% of predicted (for patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction)
- •Immunologic
- •HIV negative
- •Epstein-Barr virus positive
- •No active systemic infection
- •No autoimmune disease (e.g., autoimmune colitis or Crohn's disease)
- •No immunodeficiency due to prior chemotherapy or radiotherapy
- •Recovered immune competence after prior chemotherapy or radiotherapy as evidenced by normal lymphocyte count and WBC and an absence of opportunistic infection
- •No other major immune system disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 months after completion of study treatment
- •No other toxic effects during prior IL-2 administration that would preclude redosing with IL-2, including the following:
- •Mental status changes that would require intubation
- •Bowel perforation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •At least 4 weeks since prior systemic therapy
- 另有 8 项未显示
排除标准
- 未提供
结局指标
主要结局
Tumor regression
次要结局
- Rate of repopulation of CD25-positive T-regulatory cells
- Toxicity
研究者
研究点 (2)
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