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Evaluate the safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion and preconditioning with percutaneous hepatic perfusion in patients with liver metastases (but not restricted to) of malignant melanoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous tumor infiltrating lymphocytes (TIL) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Tumor Infiltrating Lymphocytes | Drug | Administered via hepatic arterial infusion (HAI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | Graded according to Common Terminology Criteria for Adverse Events version 5.0 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Defined as the proportion of patients with a best overall response of partial response or better defined by RECIST 1.1 | 5 years |
| Progression-free survival | Defined as the time from inclusion to objective tumor progression (determined by RECIST 1.1), or death due to any cause, whichever occurred first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Ny | Contact | +46 31 342 10 00 | lars.ny@vgregion.se | |
| Axel Nelson | Contact | axel.nelson@vgregion.se |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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| Melphalan | Drug | Administered via isolated hepatic perfusion |
|
| Interleukin-2 | Drug | low-dose, administered s.c. |
|
| 5 years |
| hepatic Progression-free survival | Defined as the time from inclusion to objective tumor progression in the liver (determined by RECIST 1.1), or death due to any cause, whichever occurred first. | 5 years |
| Duration of response | Defined as the time from the first documented response and the date of the first documented tumor progression, death, or the last tumor assessment that occurred before subsequent therapy. | 5 years |
| Overall survival | Defined as the time from inclusion to the date of death due to any cause | 5 years |
| Evaluation of Tolerability | Defined as the proportion of patients included that receive PHP and TIL | 5 years |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009930 |
| Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |