EUCTR2007-000776-16-CZ进行中（未招募）不适用
Development of Tumor Infiltrating Lymphocytes in Patients with Metastatic melanoma - TI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Age 18 – 60 yrs
- •2. Signed Informed Consent
- •3. Karnofski Index: 70% and more
- •4. Patient with new diagnose of malignant melanoma stage IV (remote organ-metastasis with measurable involvement)
- •5. Possibility of obtaining fresh tumor tissue from nodule metastasis or other metastatic tumor tissue for TIL cultivation.
- •6. Appraisal time of survivance more than 6 months in the time of generalised disease diagnosis.
- •7. Adequate mechanic (condom) or pharmacological (hormonal) contraception before menopause to restraining pregnancy during the time of treatment.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.No confirmation of metastatic melanoma diagnosis
- •2.septicaemia or active viral, bacterial or fungal systema infection within the last 7 days before imunoablative chemotherapy
- •3.Application of cytostatic agents, radiotherapy or other immunosuppresive treatment (including generalised application of corticoids) within the last 7 days before imunoablative chemotherapy
- •4.Inherence of serious parallel disease or consequential heart-disease (ischaemic heart disease, cardiac insufficiency)
- •5.Brain metastasis inherence
- •6.Inherence of previous malignant disease except of the recovered cutaneous carcinoma (spinocellular or basocellular carcinoma) OR recovered cervical cancer in situ
- •7.Pregnancy or lactation
- •8.Known seropositivity for HIV, hepatitis B or hepatitis C virus
- •9.Appearance of autoimunity diseases (for eg. Crohn disease, systematic lupus, sclerosis disseminated)
- •10.Patients in I-III clinical stage
- •11.Attendance of serious toxicity of imunoablative chemotherapy
- •12.Informed Consent is no-undersigned
- •13. No compliance or violance of The Treatment Protocol
研究者
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