Pancreatic Neoplasm Clinical Trial
Official title:
Phase II Study of EUS-Guided Verteporfin PDT in Solid Pancreatic Tumors (VERTPAC-02)
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.
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: I. Evaluate the safety of chemotherapy given two days after PDT. QUARTERNARY OBJECTIVE: I. Demonstrate that cancer biomarkers in pre- versus (vs.) post-PDT are surrogate markers of response. OUTLINE: Patients receive verteporfin intravenously (IV) and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT. After completion of study treatment, patients are followed up at 14 days, and at 3, 6, and 12 months. ;
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