NCT00082914已完成2 期
Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Clinical response
研究概览
简要总结
RATIONALE: Denileukin diftitox may be able to make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with metastatic melanoma or metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the clinical response in patients with metastatic melanoma or metastatic kidney cancer treated with denileukin diftitox.
Secondary
- Determine whether changes occur in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood of these patients before and after treatment with this drug.
- Determine the toxicity profile of this drug 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
- 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 1 of the following:
- •Kidney cancer
- •Metastatic disease
- •Measurable disease
- •Documented disease progression while receiving standard therapy
- •No resectable local or regional disease
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 90,000/mm^3
- •Lymphocyte count ≥ 500/mm^3
- •No concurrent coagulation disorders
- •Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL for patients with Gilbert's syndrome)
- •AST and ALT < 3 times normal
- •Albumin ≥ 2.5 g/dL
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Creatinine ≤ 2.0 mg/dL
- •Cardiovascular
- •Normal thallium stress test*
- •No prior myocardial infarction
- •No history of severe coronary artery disease
- •No major medical illness of the cardiovascular system NOTE: *For patients > 50 years of age OR who have a history of cardiovascular disease
- •No major medical illness of the respiratory system
- •Immunologic
- •HIV negative
- •No active systemic infection
- •No presence of opportunistic infections
- •No primary or secondary immunodeficiency
- •No autoimmune disease
- •No other known immunodeficiency
- •No sensitivity to denileukin diftitox or any of its components (e.g., diphtheria toxin, interleukin-2, or excipients)
- •Willing to undergo leukapheresis
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior treatment with interleukin-2 allowed provided the patient's disease status required this therapy
- •Chemotherapy
- •Recovered from prior chemotherapy
- •Endocrine therapy
- •No concurrent systemic steroids
- •Radiotherapy
- •Recovered from prior radiotherapy
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Clinical response
次要结局
- Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood
- Toxicity
研究者
研究点 (2)
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