NCT00072111已完成1 期
Phase I Study of Anakinra Mediated Tumor Regression and Angiogenesis Inhibition in Subjects With Cancers Producing Interleukin-1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Biological therapies, such as anakinra, may interfere with the growth of the tumor cells and slow the growth of metastatic tumors that express the interleukin-1 gene.
PURPOSE: This phase I trial is studying the side effects and best dose of anakinra in treating patients with metastatic cancer that expresses the interleukin-1 gene.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of anakinra in patients with metastatic cancer expressing the interleukin-1 gene.
- Determine the steady state pharmacokinetics of this drug in these patients.
Secondary
- Determine the antitumor efficacy of this drug in these patients.
- Determine gene expression changes in tumor biopsies and circulating leukocyte and cytokine levels in these patients before and after treatment with this drug.
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:
- •Diagnosis of metastatic cancer
- •Measurable disease
- •Able to be percutaneously biopsied with minimum morbidity on protocol NCI-99-C-0128
- •Tumor expression of interleukin-1 by biopsy
- •Progressive disease during prior standard first-line chemotherapy OR refused standard first-line chemotherapy
- •No active intracranial or leptomeningeal metastases
- •Prior radiotherapy to or resection of intracranial metastatic disease allowed provided there is no evidence of active disease on MRI or CT scan for the past month AND there is no requirement for concurrent anticonvulsant or steroid medications
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 4 months
- •Hematopoietic
- •Platelet count greater than 75,000/mm^3
- •Absolute neutrophil count greater than 1,500/mm^3
- •PT within 2 seconds of the upper limit of normal
- •Bilirubin less than 1.5 mg/dL
- •Creatinine no greater than 1.6 mg/dL OR
- •Creatinine clearance greater than 30 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •No allergy to proteins made from bacteria
- •No active infection
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 30 days since prior biologic therapy
- •No concurrent systemic immune modulators
- •Chemotherapy
- •See Disease Characteristics
- •More than 30 days since prior chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •No concurrent steroids
- •Radiotherapy
- •See Disease Characteristics
- •More than 14 days since prior localized radiotherapy to non-target lesions and recovered
- •More than 30 days since other prior radiotherapy
- •See Disease Characteristics
- •At least 30 days since prior antibiotic therapy for infection
排除标准
- 未提供
研究者
研究点 (1)
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