EUCTR2011-001474-25-DE进行中（未招募）不适用
A single-centre, single arm, open-label, exploratory trial of Interleukin-2 administered subcutaneously as neo-adjuvant treatment prior to sentinel lymph node biopsy(SLNB)/complete lymph node dissection (CLND) in subjects with stage III malignant melanoma - IL-2 s.c. in sentinel node positive Melanoma patients
Klinik für Dermatologie, Venerologie und Allergologie; Charité - Universitätsmedizin Berlin0 个研究点目标入组 20 人开始时间: 2011年9月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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
- •Inclusion criteria
- •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 (by histology of the primary and FNAC/cytology of the involved lymph node) stage III malignant melanoma according to the American Joint Committee on Cancer (AJCC 2009) within the following classification:
- •b. N1-3 (assessed by high resolution ultrasound and FNAC)
- •3. At least one lymph node with only partially malignant involvement as assessed by ultrasound
- •4. 18 years of age or above
- •5. ECOG performance status of 0 or 1
- •6. Hematology:
- •a. White blood cell (WBC) = 2.5 x 109/L
- •b. Absolute neutrophil count (ANC) = 1.5 x 109/L
- •c. Platelet count = 100 x 109/L
- •d. Hemoglobin = 100 g/L
- •7. Serum-creatinine = 1.8 mg/dL
- •8. Liver function:
- •a. ALT and Alkaline Phosphatase = 2.5 x upper limit of normal (ULN)
- •b. LDH = 2 x ULN
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Exclusion criteria
- •1. Known or suspected allergy to trial product(s) or related products
- •2. Any contraindication as listed in the product label for IL-2 (Proleukin®, Aldesleukin)
- •3. Previous participation in this trial. (Participation is defined as screening)
- •4. Any signs of stage IV disease according to AJCC 2009 as assessed by routine radiographic staging5. Prior wide excision of the primary lesion, which in the opinion of the investigator may alter lymphatic flow to the sentinel lymph nodes
- •6. Bulky lymph nodes metastases, which in the opinion of the investigator may completely obstruct lymphatic flow to the regional lymph nodes, as assessed by ultrasound
- •7. Clinically significant infection in the area of the primary tumour
- •8. Documented positive serologic testing for hepatitis B or C
- •9. History of or active presence of auto-immune diseases (except vitiligo and treated pernicious anemia)
- •10. 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
- •11. Cardiac disease within the last 12 months defined as:
- •a) decompensated heart failure (New York Heart Association (NYHA) class III or IV)
- •b) unstable angina pectoris
- •c) serious arrhythmias
- •d) myocardial infarction
- •12. Concurrent treatment with systemic corticosteroids or other immunosuppressive drugs (topical or inhaled corticosteroid treatment is permitted)
- •13. Known chronic infectious disease including human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related illness
- •14. Any significant systemic disease which according to the Investigator could compromise the safety of the subject or interfere with the trial objectives
- •15. 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, barrier methods, sexual abstinence or vasectomised partner)
- •16. The receipt of any investigational drug within 3 months prior to this trial
- •17. Location of the primary lesion where multiple injections of s.c. IL-2 are not feasible
研究者
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