NCT00416871已完成3 期
Cytokines in the Treatment of Metastatic Renal Cell Carcinoma (MRCC): Intravenous Interleukin and Subcutaneous Interferon-α Versus Subcutaneous Interleukin and Interferon-α for Good Prognosis Patients [PERCY DUO]
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
研究概览
简要总结
RATIONALE: Biological therapies, such as interleukin-2 and interferon, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether interleukin-2 given by infusion is more effective than interleukin-2 given by injection when combined with interferon in treating metastatic kidney cancer.
PURPOSE: This randomized phase III trial is studying interleukin-2 given by infusion to see how well it works compared to interleukin-2 given by injection when combined with interferon in treating patients with metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with metastatic renal cell cancer treated with intravenous vs subcutaneous interleukin-2 in combination with interferon alfa.
Secondary
- Compare progression-free survival of patients treated with these regimens.
- Compare response rates (complete and partial) in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic renal cell adenocarcinoma
- •More than one resectable metastatic site
- •No unresectable lesions after local curative treatment (i.e., radiotherapy)
- •In case of secondary lesions suspected on imaging (< 1 cm and/or sparse lesions), metastatic disease must be confirmed by biopsy OR disease progression documented by imaging performed over several weeks
- •If patient has known prior metastatic lesions, progressive disease must have been confirmed within the past 3 months by noninvasive techniques
- •Nephrectomized
- •Measurable or evaluable disease
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 90-100%
- •Hematocrit ≥ 30%
- •WBC ≥ 4,000/mm^3
- •Platelet count ≥ 120,000/mm^3
- •Bilirubin normal
- •Creatinine ≤ 1.7 mg/dL
- •FEV_1 ≥ 50%
- •No severe cardiac dysfunction (i.e., grade III/IV heart disease), including any of the following:
- •Congestive heart failure
- •Coronary artery disease
- •Uncontrolled hypertension
- •Severe arrhythmia
- •No active infections requiring antibiotic treatment
- •No severe neuropsychiatric condition
- •No geographical, psychological, or familial conditions that would preclude study treatment
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •LVEF ≥ 50%
- •No severe autoimmune disease
- •No known chronic hepatitis
- •No HIV positivity
- •No hepatitis B surface antigen positivity
- •No prior or concurrent other cancer, except basal cell skin cancer or carcinoma in situ of the cervix
- •No severe pulmonary, hepatic, or renal condition that would preclude study treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 6 weeks since prior wide-field radiotherapy
- •No prior allograft
- •No prior cytokines or chemotherapy
- •No concurrent corticosteroids
排除标准
- 未提供
研究者
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