TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA
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: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer.
详细描述
OBJECTIVES:
- Evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa.
- Assess the toxicity of this regimen.
OUTLINE: Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden.
All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5 of weeks 2-6. Patients are assessed for response approximately 2 months after initiating therapy. Patients with stable or responding disease undergo a second course; those who continue to respond may receive additional therapy provided toxicity is limited.
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 proven renal cell cancer that is metastatic
- •No greater than 50% estimated hepatic replacement by tumor on CT or MRI
- •No symptomatic involvement of the CNS or a major nerve
- •Measurable disease required
- •Ineligible for treatment with low-dose interleukin-2 on another CMC protocol
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 50%-100%
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •No coagulopathy (i.e., platelet count less than 80,000/mm3)
- •AST and ALT no greater than 5 times normal
- •Creatinine less than 4.0 mg/dL
- •Cardiovascular:
- •No symptomatic angina
- •No untreated coronary artery disease
- •No refractory arrhythmia
- •No abnormal left ventricular function
- •No dyspnea on minimal exertion
- •No site of ongoing bleeding
- •No systemic infection
- •No HIV antibody
- •No requirement for steroids
- •No psychiatric disease that precludes informed consent or protocol treatment
- •No second malignancy except:
- •Basal cell skin carcinoma
- •Carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Effective contraception required of fertile women
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior interleukin-2
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •At least 28 days since prior treatment for renal cell cancer
排除标准
- 未提供