Detection of Immune Cell Infiltration Into Melanomas Treated by PV-10, a Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Occurrence of Change in Infiltration of Immune Cells
研究概览
简要总结
The main purpose of this study is to find out more about how PV-10 works in melanoma tumors. Researchers also want to find out if there are changes in the body's immune cells (cells that fight infection and illnesses) after PV-10 is given, both inside the melanoma tumors and circulating in the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients who are diagnosed with metastatic melanoma, or who are suspected to have metastatic melanoma and are subsequently proven to have metastatic melanoma by biopsy
- •Patients who are planned to undergo surgical resection of at least two foci of palpable cutaneous or subcutaneous metastatic melanoma, for either palliative or therapeutic intent and who consent for preoperative core biopsies of at least two of the resectable lesions prior to surgery
- •Patients who have given informed consent to participate in the study
排除标准
- •Patients who decline consent for this study
- •Patients who have previously received PV-10 therapy
- •Patients who were suspected to have metastatic melanoma but are not proven by preoperative biopsy will be replaced and not counted against the accrual goal
- •Patients who do not undergo surgical resection of at least two metastatic melanoma lesions including the PV-10 treated lesion will be replaced and not counted against the accrual goal.
- •Patients whose melanoma lesions are contiguous with, encompass or infiltrate a major blood vessel
- •Patients with an allergy to shellfish due to reported cross-reactivity to PV-10
- •Patients with previous sensitivity to iodide
- •Patients who do not have a treatable target lesion on a portion of the body other than the head or neck
- •Concurrent or Intercurrent Illness:
- •Patients with a condition of impaired wound healing (such as uncontrolled diabetes mellitus or immunosuppressive steroid dependence) such that in the opinion of the PI it is unsafe for the patient to undergo intralesional PV-10 treatment
- •Patients with severe peripheral vascular disease (i.e., claudication occurring after less than 200 meters of walking, rest pain, ischemic ulceration or gangrene)
- •Patients with significant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the principal investigator (PI), compromise their safety or compliance or interfere with interpretation of study results
- •Patients with uncontrolled thyroid disease, goiter, partial thyroidectomy, previous radioiodine or surgically-treated Graves' hyperthyroidism or cystic fibrosis
- •Patients with clinically significant cardiovascular, cerebrovascular, peripheral vascular, renal, gastrointestinal, pulmonary, immunological, endocrine, bone marrow or central nervous system disorders that have required hospitalization within the past 12 months
- •Pregnancy
- •Female patients who have a positive pregnancy test or are lactating.
- •Fertile patients who do not agree to use effective contraception (i.e., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures) beginning at the time of signing consent until after surgery.
- •Patients who are dependent upon concomitant medications that predispose to photosensitivity who cannot stop the medication(s) from the period starting 24 hours prior to and ending 24 hours after PV-10 treatment will be excluded.
研究组 & 干预措施
Immunotherapy Followed by Surgery
PV-10 administration, adverse events assessment, surgery to remove melanoma tumors, follow-up visit.
干预措施: PV-10 (Drug)
Immunotherapy Followed by Surgery
PV-10 administration, adverse events assessment, surgery to remove melanoma tumors, follow-up visit.
干预措施: Surgery (Procedure)
结局指标
主要结局
Occurrence of Change in Infiltration of Immune Cells
时间窗: At baseline and 7-14 days after PV-10 treatment
The pre-treatment blood sample and tumor biopsies will be the control for the post-PV-10 blood samples and resected tumor samples. Tumor core needle biopsies will be collected from the designated injected and uninjected lesions one week prior to intralesional PV-10 therapy. Biopsy samples will be fixed in formalin and embedded in paraffin for immunohistochemical (IHC) staining. On day 0, the injected lesion will be treated with up to 5 mL of PV-10. Seven to 14 days after intralesional PV-10 treatment, the injected and uninjected lesions will be resected. A portion of each tumor equivalent to a core needle biopsy specimen will be fixed in formalin and embedded in paraffin for IHC staining. Immune cell infiltration will be compared between untreated baseline lesions and post-treatment lesions (injected or uninjected) by a blinded pathologist at Moffitt Cancer Center. Measurement is the ordinal level of the T-cell infiltration into tumors with three levels: 0, no brisk, and brisk.
次要结局
- Occurrence of Adverse Events (AEs)(During PV-10 administration visit, after 7-14 days, at study end (day 28 or early termination))
- Frequency and Phenotype of Circulating Immune Cells in Peripheral Blood Mononuclear Cells (PBMC)(At baseline, 7-14 days after treatment and 21-28 days after treatment)
- Titer of Anti-tumor IgG in the Serum(At baseline, 7-14 days after treatment and 21-28 days after treatment)