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

• Conditions: Patient with Metastatic melanoma in IV (clinical) stage of disease.

• Registration Number: EUCTR2007-000776-16-CZ
• Lead Sponsor: Masaryk University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-16
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary purpose of this clinical study (I/II phase) is the evaluation of toxicity of TIL preparation in patients with metastatic melanoma.;Secondary Objective: Secondary purposes of this study are:<br>Appreciation of immune response after autologous TIL dosage <br>Appreciation of clinical response after autologous TIL dosage in patients with metastatic melanoma<br>;Primary end point(s): Appreciation of toxicity of TIL preparation in patients with metastatic melanoma.