E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient with Metastatic melanoma in IV (clinical) stage of disease. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary purpose of this clinical study (I/II phase) is the evaluation of toxicity of TIL preparation in patients with metastatic melanoma. |
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E.2.2 | Secondary objectives of the trial |
Secondary purposes of this study are: Appreciation of immune response after autologous TIL dosage Appreciation of clinical response after autologous TIL dosage in patients with metastatic melanoma
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Appreciation of toxicity of TIL preparation in patients with metastatic melanoma. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Days 180 after first TIL application. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |