NCT07364474招募中不适用
Evaluating Immune Response to Percutaneous Hepatic Perfusion With Melphalan for the Treatment of Ocular Melanoma Metastatic to the Liver
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Intratumoral CXCL13⁺ CD8⁺ T-cell infiltration following Percutaneous Hepatic Perfusion (PHP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has histologically or cytologically confirmed diagnosis of uveal melanoma metastatic to the liver and is determined to be a candidate for percutaneous hepatic perfusion with melphalan
- •The subject has read, signed and dated the Informed Consent Form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject.
- •Age > 18 years at date of informed consent signature having the ability to comply with the protocol.
- •Contrast-enhanced cross-sectional imaging of the abdomen (either CT or MRI) obtained within two months prior to study enrollment
- •Measurable metastatic disease. Subject must have at least one site of metastatic disease ≥ 1 cm in size and amenable to percutaneous image-guided biopsy
- •Life expectancy > 12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Laboratory requirements:
- •Absolute neutrophil count (ANC) > 1 x 109/L
- •Platelets > 75 x 109/L
- •Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) < 5 x ULN
- •Total bilirubin <3 mg/dL
- •International normalized ratio (INR) <1.7
- •Glomerular filtration rate (GFR) >30 ml/min
排除标准
- •Lesion to undergo biopsy cannot have undergone prior radiation therapy or other locoregional therapy
- •Continued adverse events from a previously administered chemotherapeutic agents. Grade 1 adverse events and ongoing toxicities such as alopecia are exempt
- •Treatment with systemic corticosteroids exceeding the equivalent of 10 mg/day of prednisone or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, and anti-tumor necrosis factor [anti-tumor necrosis factor (TNF)] agents) within 2 weeks prior to Day 1, or anticipated requirement for systemic immunosuppressive medications exceeding the equivalent of 10 mg/day of prednisone during the trial
- •Patients who receive acute, low-dose, systemic corticosteroid medications (e.g., a one-time dose of dexamethasone for nausea) or for prevention of hypersensitivity reactions to contrast agents may be enrolled in the trial.
- •Anticoagulant or anti-platelet medication that cannot be interrupted prior to biopsy
- •Pregnant or lactating
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or that could affect the interpretation of the results or render the patient at high risk from treatment complications.
- •Treatment with systemic immunostimulatory agents (including but not limited to interferon(IFN)s, interleukin [IL]-2) within 6 weeks or five half- lives of the drug, whichever was shorter, prior to Day
- •Treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, anti-LAG-3 antibodies, within the past three months. Prior treatment with tebentafusp is allowed with no washout period required.
- •Treatment with any investigational systemic medication within at least one month prior to biopsy. If an investigational agent is an immune checkpoint inhibitor, a three-month washout is required. Prior treatment with Darovasertib and Crizotinib is allowed with no washout period required.
- •Signs or symptoms clinically significant of infection within 2 weeks prior to Day 1.
研究组 & 干预措施
Melphalan through Percutaneous Hepatic Perfusion
Other
Single arm
干预措施: Melphalan through Percutaneous Hepatic Perfusion (Drug)
结局指标
主要结局
Intratumoral CXCL13⁺ CD8⁺ T-cell infiltration following Percutaneous Hepatic Perfusion (PHP)
时间窗: 3-4 weeks post treatment
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.
次要结局
- Antigen-presenting cell (APC) populations and their activation state in the tumor microenvironment.(28-42 day tumor biopsies)
- T-cell infiltration in tumor and adjacent hepatic parenchyma.(28-42 days post treatment)
- Single-cell RNA sequencing derived frequency of macrophages and myeloid-derived suppressor cells (MDSCs)(28-42 days post treatment)
- Single-cell RNA sequencing derived phenotype of macrophages and myeloid-derived suppressor cells (MDSCs)(28-42 days post treatment)
- Immune cell populations with molecular and biochemical features of tissue and peripheral blood.(28-42 days post treatment.)
研究者
Eric Wehrenberg-Klee, MD
Dana-Farber/Harvard Cancer Center Investigator
Massachusetts General Hospital
研究点 (1)
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