EUCTR2012-001991-13-IT进行中（未招募）不适用
A phase II study of intratumoral application of L19IL2/L19TNF in melanoma patients in clinical stage III or stage IV M1a with presence of injectable cutaneous and/or subcutaneous lesions. - Intratumoral administration of L19IL2/L19TNF
PHILOGEN S.P.A.0 个研究点目标入组 20 人开始时间: 2012年7月26日最近更新:
适应症
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
- •1)Histologically confirmed malignant melanoma of the skin in clinical stage III or stage IV M1a 2)Presence of measurable and injectable cutaneous and/or subcutaneous lesions 3)Males or females, age >/= 18 years 4)ECOG/WHO performance status 1.5 x 10^9/L 7)Hemoglobin > 9.0 g/dL 8)Platelets > 100 x 10^9/L 9)Total bilirubin 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
- •1) Uveal melanoma and mucosal melanoma 2)Evidence of visceral metastases and/or active brain metastases at screening 3)Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis & Ti) or any cancer curatively treated < 5 years prior to study entry 4)History of HIV infection or infectious hepatitis B or C 5)Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. 6)History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris. 7)Inadequately controlled cardiac arrhythmias including atrial fibrillation 8)Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria) 9)Uncontrolled hypertension 10)Ischemic peripheral vascular disease (Grade IIb-IV) 11)Severe diabetic retinopathy 12)Active autoimmune disease 13)History of organ allograft or stem cell transplantation 14)Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment. 15)Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies. 16)Breast feeding female 17)Anti-tumor therapy within 4 weeks of the administration of study treatment (except small surgery). 18)Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment. 19)Planned administration of growth factors or immunomodulatory agents within 7 days before the administration of study treatment 20)Patients in need of systemic treatment for rapidly progressive systemic disease. 21)Patient requires or is taking corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion. oAny conditions that in the opinion of the investigator could hamper compliance with the study protocol.
研究者
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