EUCTR2006-005350-79-DE进行中（未招募）不适用
A single arm, single-centre, open-label, exploratory trial of recombinant Interleukin-21 administered subcutaneously for 4 weeks as neo-adjuvant treatment prior to sentinel lymph node/complete lymph node dissection followed by 8 weeks of adjuvant treatment in subject with stage III malignant melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- •2.Confirmed histologically stage III malignant melanoma according to the American Joint Committee on Cancer (AJCC 2006) within the following classification:
- •-N1-3 (assessed by high resolution ultrasound)
- •3.At least one lymph node with only partial malignant involvement as assessed by ultrasonography
- •4.18 years of age or above
- •5.ECOG performance status of 0 or 1
- •6.Haematology:
- •-White blood cell (WBC) = 2.5 x 10^9/L
- •-Absolute neutrophil count (ANC) = 1.5 x 10^9/L
- •-Platelet count = 100 x 10^9/L
- •-Haemoglobin = 100 g/L
- •7.S-creatinine = 1.8 mg/dL
- •8.Liver function:
- •-ALT and Alkaline Phosphatase = 2.5 x upper limit of normal (ULN)
- •-LDH = 2 x ULN
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Known or suspected allergy to trial product(s) or related products
- •2.Previous participation in this trial. Participation is defined as screening
- •3.Any signs of stage IV disease according to AJCC 2006 as assessed by routine radiographic staging
- •4.Prior wide excision of the primary lesion
- •5.Bulky lymph nodes metastases larger than 2 cm in longest diameter as assessed by ultrasonography
- •6.Clinically significant infection in the area of the primary tumour
- •7.Documented positive serologic testing for hepatitis B or C
- •8.History of or active presence of auto-immune diseases (except vitiligo and treated pernicious anaemia)
- •9.History of any other active malignancy incl. ocular malignant melanoma (except basal cell carcinoma of the skin and cervical cancer in situ) within 5 years of enrolment
- •10.Cardiac disease within the last 12 months defined as:
- •-decompensate heart failure (New York Heart Association (NYHA) class III or IV)
- •-serious arrhythmias
- •-unstable angina pectoris
- •-myocardial infarction
- •11.Concurrent treatment with systemic corticosteroids or other immunosuppresive drugs (topical or inhaled corticosteroid treatment is permitted)
- •12.Known chronic infectious disease including human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related illness
- •13.Any significant systemic disease which according to the Investigator could compromise the safety of the subject or interfere with the trial objectives
- •14.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence, or vasectomised partner)
- •15.The receipt of any investigational drug within 3 months prior to this trial
- •16.Location of the primary lesion where multiple injections of rIL-21 are not possible
研究者
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