NCT00080977Unknown2 期
Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2
Blumenthal Cancer Center at Carolinas Medical Center2 个研究点 分布在 1 个国家开始时间: 1998年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 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 renal cell carcinoma (kidney cancer) cells.
PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.
详细描述
OBJECTIVES:
- Determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (IL-2) when treated with high-dose intravenous IL-2.
- Determine the overall survival, disease-free survival, and time to progression in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a pilot study.
Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses (course 1).
Patients are assesed for response 2 months after initiation of treatment. Patients with responding or stable disease receive a second course of therapy. Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable 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 renal cell carcinoma
- •Metastatic disease
- •No pure papillary or sarcomatoid variants
- •Measurable disease
- •Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2
- •Documented disease progression
- •No estimated hepatic replacement by tumor > 25% by CT scan or MRI
- •No tumor involving the CNS or a major nerve
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 80-100%
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Platelet count ≥ 80,000/mm^3
- •No sites of ongoing bleeding
- •See Disease Characteristics
- •Bilirubin ≤ 1.4 mg/dL
- •AST and ALT ≤ 3 times normal
- •PT or PTT INR ≤ 1.2
- •Hepatitis B surface antigen negative
- •Hepatitis C virus negative
- •No coagulation disorders
- •Creatinine ≤ 1.6 mg/dL
- •Cardiovascular
- •No ongoing ischemia*
- •No cardiac dysfunction*
- •No abnormal ejection fraction* NOTE: *A cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram
- •FEV_1 ≤ 65% of predicted*
- •Vital capacity ≤ 65% of predicted* NOTE: *Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph
- •HIV negative
- •No systemic infections
- •No other malignancy except carcinoma in situ
- •No psychiatric illness that would preclude study participation or compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •No concurrent steroids
- •Radiotherapy
- •Not specified
- •Not specified
- •More than 28 days since other prior treatment for renal cell cancer
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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