NCT02155322已完成2 期
A Phase II Study of Pegylated Interferon Alfa-2b in AJCC Stage III (TxN1-2M0) Melanoma Subjects After Regional Lymph Node Dissection in Russia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Percentage of Participants Experiencing Adverse Events (AEs)
研究概览
简要总结
This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Competent to self-administer the subcutaneous injections of PEG-IFN
- •Histologically documented involved regional lymph nodes of a primary cutaneous melanoma or unknown primary, meeting the study's staging criteria
- •Had the primary melanoma completely resected with adequate surgical margins and undergone operation for positive regional lymph nodes within 84 days of study start
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- •Adequate hepatic, renal and bone marrow function as defined by study parameters obtained within 4 weeks prior to study start
- •For a female subject who is of childbearing potential or male participant with female sexual partner who is of childbearing potential, agree to use acceptable methods of contraception for at least 2 weeks prior to study start and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations
排除标准
- •Mucous membrane melanoma or ocular melanoma
- •Known hypersensitivity to the components of study drug (including acetaminophen), or its analogs
- •Evidence of distant or non-regional lymph node metastases or in-transit metastases
- •Disease that cannot be completely surgically resected
- •Prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ
- •Severe cardiovascular disease, i.e. arrhythmias, requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease
- •Hepatic decompensation
- •Thyroid dysfunction not responsive to therapy
- •Uncontrolled diabetes mellitus
- •Clinically active autoimmune disease
- •Clinically active and/or uncontrolled infection, including active hepatitis
- •Human immunodeficiency virus (HIV)
- •History of neuropsychiatric disorder requiring hospitalization
- •Actively abusing alcohol or drugs
- •Pregnant, lactating, or of reproductive potential and not using an effective means of contraception
- •Medical condition requiring chronic systemic corticosteroids
- •Received any experimental therapy within 30 days prior to enrolling in this study
- •Received any prior chemotherapy, immunotherapy, hormonal or radiation therapy for melanoma
- •Previously received interferon-α for any reason
- •Known serious hypersensitivity reaction to PEG-IFN or interferon alfa-2b
结局指标
主要结局
Percentage of Participants Experiencing Adverse Events (AEs)
时间窗: From first dose through follow-up; up to 13 months
An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Percentage of Participants Discontinuing Study Drug Because of AEs
时间窗: From first dose to last dose of treatment; up to 12 months
An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
次要结局
未报告次要终点
研究者
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