NCT00002846Unknown2 期
TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2
Blumenthal Cancer Center at Carolinas Medical Center2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 1995年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 14
- 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 II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.
详细描述
OBJECTIVES:
- Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2.
- Assess the toxicity associated with this treatment.
OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited.
Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy.
Patients are followed for survival.
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 (RCC) that is metastatic or recurrent
- •No central nervous system or major nerve involvement
- •No more than 25% estimated hepatic replacement by tumor on CT or MRI
- •Measurable disease required
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 80%-100%
- •Life expectancy:
- •Greater than 3 months
- •Hematopoietic:
- •Platelet count at least 80,000/mm3
- •Bilirubin normal
- •AST and ALT no greater than 3 times normal
- •Creatinine normal
- •Cardiovascular:
- •Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG)
- •FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray)
- •No sites of ongoing bleeding
- •No HIV antibody or AIDS
- •No hepatitis B antigen
- •No systemic infection
- •No requirement for steroids
- •No psychiatric disease that precludes informed consent or safe administration of immunotherapy
- •No second malignancy except:
- •Basal cell carcinoma
- •In situ cervical cancer
- •Other cancer provided all evaluable lesions are documented RCC
- •No pregnant or nursing women
- •Effective contraception required of fertile women
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior interleukin-2 therapy
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •At least 28 days since therapy for RCC
排除标准
- 未提供
研究者
研究点 (2)
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