NCT00204529已完成3 期
Randomized, Multicenter, Open Label Study to Compare the Efficacy and Tolerability of Pegylated Interferon-alpha-2 (PEG-IFN) to 'Low-dose' Interferon-alpha-2a in Patients With Malignant Melanoma in Stages IIA (T3a) - IIIB (AJCC 2002)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 901
- 试验地点
- 1
- 主要终点
- Time to distant metastasis
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant melanoma in stage IIA (T3a) - IIIB.
A total of 880 will be randomized up to three months after first surgical management of their melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven cutaneous melanoma
- •≥ 18 years of age and < 75 years of age
- •Have confirmed stage IIa (T3a), IIB, IIC, IIIA or IIIB (AJCC 2002) melanoma (lymph node staging either per sentinel node biopsy or elective lymph node dissection)
- •Have a Karnofsky performance status of ≥ 80%
- •Negative pregnancy test
- •Start of therapy within three months after surgery
- •Informed consent
排除标准
- •Pregnant or lactating women
- •Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment in female or male patients
- •Mucous membrane or ocular melanoma
- •Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound or CT and ultrasound of regional lymph nodes at screening)
- •Patients who have received chemotherapy or vaccines for melanoma
- •Patients with tumor progression under a previous adjuvant interferon therapy or within three months after termination of interferon therapy (patients previously receiving adjuvant interferon therapy in another tumor stage without disease progression may be included)
- •History of any other malignancy within the last ten years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix)
- •Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina), severe liver disease or severe renal disease.
- •ALAT or ASAT > 2 x ULN
- •Bilirubin > 2 x ULN
- •Creatinine > 2 x ULN
- •Patients who have a history of depression or other psychiatric diseases requiring hospitalisation
- •Patients with seizure disorders requiring anticonvulsant therapy
- •Any of the following abnormal baseline hematologic/laboratory values:
- •Hb <10g/dl
- •WBC <3.0 x 109 /l
- •Platelets <100x109/l
- •Neutrophils < 1.5 x 109/l
- •History or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroid auto-immune dysfunction, systemic lupus erythematodes)
- •Unwilling or unable to comply with the requirements of the protocol for the duration of the study
- •Known infection with HBV, HCV, HIV
- •Evidence of allergy or hypersensitivity against IFN or pegylated interferon
- •Thyroid disease poorly controlled on prescribed medications
- •Systemic corticosteroid therapy for any reason (>1 month)
研究组 & 干预措施
PegIFN
Experimental
pegylated interferon-alpha-2a
干预措施: pegylated interferon-alpha-2a (Drug)
IFN
Active Comparator
interferon-alpha-2a
干预措施: interferon-alpha-2a (Drug)
结局指标
主要结局
Time to distant metastasis
时间窗: From date of randomization until the date of first documented distant metastases or date of death from any cause, whichever came first, assessed up to 60 months
次要结局
- Overall survival(5 years)
- Quality of life(Measured at different visits (week 0, week 12, month 3, month 6))
- Disease free survival(5 years)
- Number and Grade of Adverse Events(Measured at every visit (week 4, week 8, week 12, month 3, month 6 and every 3 months during therapy))
研究者
Thomas Eigentler
MD
University Hospital Tuebingen
研究点 (1)
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