Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 12/31/2018 |
| Pirmasis pateikimas: | 11/26/2015 |
| Numatytas registravimas pateiktas: | 01/06/2016 |
| Pirmas paskelbtas: | 01/07/2016 |
| Paskutinis atnaujinimas pateiktas: | 01/28/2019 |
| Paskutinis atnaujinimas paskelbtas: | 01/29/2019 |
| Faktinė studijų pradžios data: | 09/30/2015 |
| Numatoma pirminio užbaigimo data: | 05/31/2020 |
| Numatoma studijų užbaigimo data: | 09/30/2020 |
Būklė ar liga
Intervencija / gydymas
Device: imILT
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: imILT Immunostimulating Interstitial Laser Thermotherapy (imILT) | Device: imILT Immunostimulating Interstitial Laser Thermotherpy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - >18 years of age - histologically confirmed malignant melanoma - advanced melanoma disease (Stage III inoperable or Stage IV) that has progressed on standard first line treatment such as kinase inhibitor(s) and/or immunoregulatory monoclonal antibodies. Previously untreated patients with a dominant tumour lesion deemed suitable for local and highly tumour-destructive ablation may also be included - time interval between previous systemic treatment and imILT of at least one month - at least one lesion located in such a way (typically subcutaneously) that it can be treated without risk of skin necrosis or serious damage to other adjacent vital and healthy tissue - verbal and written informed consent to participate - adequate haematologic, renal and hepatic functions - have an ECOG performance status ≤ 2 (Karnofsky ≥ 60%) Exclusion Criteria: - known HIV infection - autoimmune disease which is judged to reduce an anti-tumour immune response - systemic corticosteroid medication - bleeding diathesis - pregnancy or breast-feeding |
Rezultatas
Pirminės rezultatų priemonės
1. Safety (adverse events) [18 months]
2. Usability of the device as evaluated by treatment logs [18 months]
3. Usability of the device as evaluated by user questionnaire [18 months]
Antrinės rezultatų priemonės
1. Treatment effect (Measurement of tumor burden by irRC criteria) [18 months]
2. Inflammatory response in tumor and circulation measured by quantification of inflammatory cell populations [18 months]
