NCT00039052已完成1 期
An Open Label, Multiple-Dose, Sequential Dose-Escalation Study of NBI-3001 in Patients With Recurrent or Unresponsive Solid Tumors Known to Over-Express IL-4 Receptors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Interleukin-4 PE38KDEL cytotoxin may be able to deliver cancer-killing substances directly to solid tumor cells.
PURPOSE: Phase I trial to study the effectiveness of intravenous interleukin-4 PE38KDEL cytotoxin in treating patients who have recurrent or metastatic kidney cancer, non-small cell lung cancer, or breast cancer that has not responded to previous treatment.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of interleukin-4 PE38KDEL cytotoxin in patients with recurrent or unresponsive, metastatic renal cell, non-small cell lung, or breast cancer that overexpresses interleukin-4 receptors.
- Determine the qualitative and quantitative toxic effects of this drug, including the duration and intensity of these toxic effects, in these patients.
- Determine the pharmacokinetic behavior of this drug in these patients.
- Determine the antibody response (if any) in patients treated with this drug.
- Determine, in a preliminary manner, the antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive interleukin-4 PE38KDEL cytotoxin (NBI-3001) IV over 10 minutes once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity, or detection of neutralizing antibodies.
Cohorts of 3-6 patients receive escalating doses of NBI-3001 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed recurrent or unresponsive, metastatic renal cell, non-small cell lung, or breast cancer that has been treated previously with standard surgery, radiotherapy, chemotherapy, or immunotherapy or for which no available treatment options currently exist
- •Confirmed overexpression of interleukin-4 receptors
- •Measurable disease (lesions greater than 10 mm by CT scan) OR
- •Evaluable disease
- •No prior or concurrent clinically significant brain metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Male or female
- •Menopausal status:
- •Not specified
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •More than 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Transaminases no greater than 1.5 times ULN
- •Albumin at least 2.5 g/dL
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •No prior or concurrent hepatic disease (e.g., hepatitis or alcoholic liver disease)
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •See Surgery
- •Electrocardiogram normal
- •MUGA scan normal
- •No congestive heart failure
- •No cardiac arrhythmia requiring treatment
- •No myocardial infarction
- •No clinical evidence of coronary artery disease (unless there is a cardiac evaluation and evidence of adequate coronary function by a stress test or angiography)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception for 4 weeks before, during, and for at least 3 months after study
- •No concurrent underlying medical condition that would preclude study or cannot be controlled
- •No active infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
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排除标准
- 未提供
研究者
研究点 (2)
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