Phase II Study of EUS-Guided Verteporfin PDT in Solid Pancreatic Tumors (VERTPAC-02)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
This phase II trial studies how well ultrasound-guided verteporfin photodynamic therapy works for the treatment of patients with solid pancreatic tumors that cannot be removed by surgery (unresectable) or pancreatic cancer that has spread to other places in the body (advanced). Photodynamic therapy is a type of laser device that is guided by ultrasound imaging and used in combination with the drug verteporfin that may be less invasive and as effective as current treatment methods for patients with pancreatic cancer.
详细描述
PRIMARY OBJECTIVE:
I. To show that endoscopic ultrasound (EUS)-guided photodynamic therapy (PDT) to the pancreas is effective at direct ablation of advanced or locally advanced and small volume metastatic pancreatic tumors in a multicenter setting.
SECONDARY OBJECTIVE:
I. To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans.
TERTIARY OBJECTIVE:
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
- •Histological/cytological diagnosis (Dx) of advanced or locally advanced or small volume metastatic pancreatic cancer (PanCa) or other solid pancreatic tumor that is not amenable to curative surgical resection, or the patient is unfit, or declines surgery
- •Age > 18 years
- •Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- •Estimated life expectancy of at least 12 weeks
- •Capable of giving written informed consent
- •Adequate biliary drainage (serum bilirubin < 2.5 upper limit of normal [ULN]), with no evidence of active uncontrolled infection (patients on antibiotics are eligible)
- •Women of child-bearing potential with a negative pregnancy test (qualitative serum human chorionic gonadotropin [HCG]) prior to study entry AND must be using an adequate contraception method, which must be continued for 1 week after PDT
排除标准
- •For locally advanced patients, evidence of metastases other than lung or liver. For lung metastases, greater than three lesions and any lesions greater than 5 cm are excluded. For advanced patients, any metastasis is acceptable for enrollment
- •Porphyria
- •Pregnant or breast-feeding
- •Locally advanced disease involving > 50% circumference of the duodenum or a major artery within the treatment area
- •ECOG performance status 3 or 4
- •Previous treatment with curative intent for current disease within the past two weeks (i.e. prior resection, radical radiotherapy or chemotherapy)
- •Any psychiatric disorder making reliable informed consent impossible
- •A history of documented hemorrhagic diathesis or coagulopathy on therapeutic anticoagulation
- •History of prior or concomitant other malignancy that will interfere with the response evaluation
- •Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
- •Contrast allergy not amenable to treatment with steroids and antihistamines
研究组 & 干预措施
Treatment (verteporfin, EUS-guided PDT)
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
干预措施: Endoscopic Ultrasound (Procedure)
Treatment (verteporfin, EUS-guided PDT)
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
干预措施: Fluorescence Imaging (Procedure)
Treatment (verteporfin, EUS-guided PDT)
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
干预措施: Photodynamic Therapy (Drug)
Treatment (verteporfin, EUS-guided PDT)
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
干预措施: Quality-of-Life Assessment (Other)
Treatment (verteporfin, EUS-guided PDT)
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
干预措施: Questionnaire Administration (Other)
Treatment (verteporfin, EUS-guided PDT)
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
干预措施: Verteporfin (Drug)
结局指标
主要结局
Tumor Response
时间窗: Baseline (up to 28 days before PDF); 2 days post PDT; Up to 12 months post PDT
Assessed by the number of participants who did or did not respond, evaluated by tumor necrosis as a function of delivered energy, based on pre-photodynamic therapy (PDT) contrast computed tomography (CT) scans. Tumor volume response was graded per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CT scans were obtained on day 2 following PDT. Most patients (87.5%) had a repeat CT of the abdomen and pelvis for reasons unrelated to the study; these CTs were also reviewed for tumor response.
次要结局
未报告次要终点