Randomized, Multicenter Study for Adjuvant Treatment of Stage III Malignant Melanoma: Intermittent, High-Dose Intravenous Interferon Alpha-2b Versus Standard High-Dose Interferon Alpha-2b Therapy
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 600
- 试验地点
- 26
- 主要终点
- distant metastasis free survival/(DMFI )
研究概览
简要总结
The study protocol is being conducted to compare intermittent high-dose i.v. administation of interferon alpha-2b with the standard high-dose treatment by Kirkwood with distant metastasis free survival (DMFI) as a primary endpoint.
详细描述
Arm A: Interferon-alpha-2b 20 MIU/m2 for 4 weeks. 5 days a week i.v followed by 48 weeks of treatment with 3 x 10 MIU/m2 s.c Arm B: Interferon-alpha-2b 20 MIU/m2 for 4 weeks. 5 days a week i.v repeated 3 times with 12 treatment-free-weeks between the cycles
Secondary endpoints: Improved overall survival rate, Assess side effects of therapy in both treatment arms, Assess time spent on sick leave, Assess number of treatment-related days in hospital, Assess overall performance status, Assess blood MX protein levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histological documentet cutaneous malognant melanoma
- •Stage IIIa, IIIb, IIIc (AJCC 2002)
- •R0 resection dating back no longer than 56 days
- •Performance status (ECOG o-1)
- •Bone marrow funktion: White cell count > 3000 cells/ul, platletts > 100000 cells/ul, hemoglobin > 10 g/dl
- •Liver and kidney funktion: Serum creatinin < 1.5 times upper limit of normal, AST and ALT < 2.5 times upper limit of normal, Serum bilirubin < 2 times upper limit of normal
- •Written inform consent
排除标准
- •Confirmed distant metastasis
- •Choroid or mucosal melanoma
- •Pregnant or lactating women and women of childbearing potential not using a reliable form of contraception
- •Active autoimmun disease
- •patients with history of neuropsychiatric disease requiring hospitalization
- •Severe medical condition such us:
- •Florid hepatitis
- •Severe acute infection
- •Myocardial infarction within the past year,symptomatic angina pectoris
- •Grade III to IV congestive heart failure
- •serious pulmonary disease
- •HIV-positive patients with an AIDS - defining condition
- •treatment in another clinical drug trial within the last 30 days
- •A history of hypersensitivity to interferon alfa
- •History of maignant disease during the past 5 years (except for curatively treated skin carcinoma or in situ carcinoma)
- •Prior high dose interferon alfa therapy.Prior adjuvant low dose or intermediate-dose interferon alfa therapy is allowed
结局指标
主要结局
distant metastasis free survival/(DMFI )
次要结局
- overall survival
- time to progression
- toxicity