This study seeks to better understand the liver's immune response to receiving chemotherapy agent melphalan through Percutaneous Hepatic Perfusion (PHP) for patients with Uveal Melanoma that has metastasized to the liver.
Biopsies and blood samples will be collected before treatment to establish baseline measurements. Patients will then receive a single dose of Melphalan via Percutaneous Hepatic Perfusion (PHP) and return 21-28 days later for a follow-up biopsy and peripheral blood draw. Baseline and post-treatment samples will be compared to evaluate the immune response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Melphalan through Percutaneous Hepatic Perfusion will be received as standard of care,
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGIntratumoral CXCL13⁺ CD8⁺ T-cell infiltration following Percutaneous Hepatic Perfusion (PHP)
Change in the percentage of CXCL13⁺ CD8⁺ T cells in tumor biopsies between Day 0 (pre-treatment) and Day 28-42 (approximately 3-4 weeks post-treatment), as measured by single-cell RNA sequencing.
Time frame: 3-4 weeks post treatment
Antigen-presenting cell (APC) populations and their activation state in the tumor microenvironment.
Comparison of proportions and activation markers of dendritic cells and other APC subsets in pre-treatment (Day 0) and post-treatment (Day 28-42) tumor biopsies.
Time frame: 28-42 day tumor biopsies
T-cell infiltration in tumor and adjacent hepatic parenchyma.
Change in FOXP3⁺ regulatory T-cell infiltration between pre-treatment (Day 0) and post-treatment (Day 28-42) tumor and parenchymal biopsies.
Time frame: 28-42 days post treatment
Single-cell RNA sequencing derived frequency of macrophages and myeloid-derived suppressor cells (MDSCs)
Change in the frequency of macrophages and myeloid-derived suppressor cells (MDSCs) between pre-treatment (Day 0) and post-treatment (Day 28-42) samples as assessed by single-cell RNA sequencing.
Time frame: 28-42 days post treatment
Single-cell RNA sequencing derived phenotype of macrophages and myeloid-derived suppressor cells (MDSCs)
Change in the phenotype of macrophages and myeloid-derived suppressor cells (MDSCs) between pre-treatment (Day 0) and post-treatment (Day 28-42) samples.
Time frame: 28-42 days post treatment
Immune cell populations with molecular and biochemical features of tissue and peripheral blood.
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Correlation between tissue-based immune cell changes and peripheral biomarkers (e.g. cytokine expression (ng/ml), ctDNA (mtm/ml)) assessed at Day 0 and Day 28-42, and with hepatic radiologic response assessed on CT/MRI as per clinical standard of care .
Time frame: 28-42 days post treatment.