Development of Tumor Infiltrating Lymphocytes in Patients with Metastatic melanoma - TI

Masaryk University0 sitesMay 16, 2007

Overview

No summary available.

Registry

who.int

Start Date

May 16, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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