NCT00006864已完成4 期
Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.
PURPOSE: Phase IV trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer.
详细描述
OBJECTIVES:
- Determine the overall response rate, complete and partial response rates, and duration of response in patients with metastatic renal cell carcinoma treated with low-dose interleukin-2.
- Determine the overall survival, one-year progression-free survival, and two-year progression-free survival in patients treated with this regimen.
- Determine the incidence of adverse events in these patients.
OUTLINE: This is a multicenter study.
Patients receive low-dose interleukin-2 subcutaneously 5 days a week for 6 weeks. Courses repeat every 9 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years.
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 proven metastatic renal cell carcinoma
- •Clear cell
- •Papillary
- •Sarcomatoid
- •Measurable or evaluable disease
- •Evidence of disease following surgical resection of metastases
- •No CNS disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hemoglobin at least 10 g/dL
- •WBC at least 4,000/mm3
- •Platelet count at least 100,000/mm3
- •Not specified
- •Creatinine no greater than 1.8 mg/dL
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception (barrier plus 1 other method)
- •Thyroid-stimulating hormone normal
- •No known hypersensitivity or allergy to components of recombinant human interleukin-2
- •No known autoimmune disease (e.g., Crohn's disease)
- •No other concurrent medical condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior recombinant human interleukin-2
- •No concurrent interferon alfa
- •Chemotherapy:
- •No concurrent cytoxic chemotherapy
- •Endocrine therapy:
- •No concurrent hormonal therapy (e.g., medroxyprogesterone) other than estrogen replacement therapy
- •No concurrent prophylactic glucocorticoids (replacement doses and topical use allowed)
- •No concurrent systemic corticosteroids
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No prior radiotherapy to index lesion
- •No concurrent radiotherapy
- •See Disease Characteristics
- •Prior surgery for renal cell carcinoma allowed
- •No prior systemic therapy for renal cell carcinoma
- •At least 4 weeks since prior investigational drugs
- •No other concurrent investigational drugs or participation in another clinical study
- •No concurrent iodinated radiocontrast dye
- •No concurrent drugs for another indication that has purported activity in treatment of neoplasia (e.g., thalidomide)
排除标准
- 未提供
研究者
研究点 (2)
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