<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03033225</url>
  </required_header>
  <id_info>
    <org_study_id>16-001243</org_study_id>
    <secondary_id>NCI-2019-07003</secondary_id>
    <secondary_id>16-001243</secondary_id>
    <secondary_id>P30CA015083</secondary_id>
    <nct_id>NCT03033225</nct_id>
  </id_info>
  <brief_title>Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study</brief_title>
  <official_title>Phase II Study of EUS-Guided Verteporfin PDT in Solid Pancreatic Tumors (VERTPAC-02)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <brief_summary>
    <textblock>
      This phase II trial studies how well ultrasound-guided verteporfin photodynamic therapy works&#xD;
      for the treatment of patients with solid pancreatic tumors that cannot be removed by surgery&#xD;
      (unresectable) or pancreatic cancer that has spread to other places in the body (advanced).&#xD;
      Photodynamic therapy is a type of laser device that is guided by ultrasound imaging and used&#xD;
      in combination with the drug verteporfin that may be less invasive and as effective as&#xD;
      current treatment methods for patients with pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To show that endoscopic ultrasound (EUS)-guided photodynamic therapy (PDT) to the pancreas&#xD;
      is effective at direct ablation of advanced or locally advanced and small volume metastatic&#xD;
      pancreatic tumors in a multicenter setting.&#xD;
&#xD;
      SECONDARY OBJECTIVE:&#xD;
&#xD;
      I. To evaluate the predictability of tumor necrosis as a function of delivered energy, based&#xD;
      on pre-PDT contrast computed tomography (CT) scans.&#xD;
&#xD;
      TERTIARY OBJECTIVE:&#xD;
&#xD;
      I. Evaluate the safety of chemotherapy given two days after PDT.&#xD;
&#xD;
      QUARTERNARY OBJECTIVE:&#xD;
&#xD;
      I. Demonstrate that cancer biomarkers in pre- versus (vs.) post-PDT are surrogate markers of&#xD;
      response.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive verteporfin intravenously (IV) and undergo fluorescence imaging and after 60&#xD;
      minutes undergo EUS-guided PDT.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 14 days, and at 3, 6, and 12&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 6, 2016</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor response</measure>
    <time_frame>12 months post photodynamic therapy (PDT)</time_frame>
    <description>To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Advanced Pancreatic Carcinoma</condition>
  <condition>Locally Advanced Pancreatic Carcinoma</condition>
  <condition>Metastatic Pancreatic Carcinoma</condition>
  <condition>Pancreatic Neoplasm</condition>
  <condition>Stage II Pancreatic Cancer AJCC v8</condition>
  <condition>Stage III Pancreatic Cancer AJCC v8</condition>
  <condition>Stage IV Pancreatic Cancer AJCC v8</condition>
  <condition>Unresectable Pancreatic Carcinoma</condition>
  <arm_group>
    <arm_group_label>Treatment (verteporfin, EUS-guided PDT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Ultrasound</intervention_name>
    <description>Undergo EUS-guided PDT</description>
    <arm_group_label>Treatment (verteporfin, EUS-guided PDT)</arm_group_label>
    <other_name>endosonography</other_name>
    <other_name>EUS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fluorescence Imaging</intervention_name>
    <description>Undergo fluorescence imaging</description>
    <arm_group_label>Treatment (verteporfin, EUS-guided PDT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Photodynamic Therapy</intervention_name>
    <description>Undergo EUS-guided PDT</description>
    <arm_group_label>Treatment (verteporfin, EUS-guided PDT)</arm_group_label>
    <other_name>PDT</other_name>
    <other_name>Photoradiation Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (verteporfin, EUS-guided PDT)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (verteporfin, EUS-guided PDT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Verteporfin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (verteporfin, EUS-guided PDT)</arm_group_label>
    <other_name>Benzoporphyrin Derivative Monoacid Ring A</other_name>
    <other_name>BPD-MA</other_name>
    <other_name>Visudyne</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological/cytological diagnosis (Dx) of advanced or locally advanced or small&#xD;
             volume metastatic pancreatic cancer (PanCa) or other solid pancreatic tumor that is&#xD;
             not amenable to curative surgical resection, or the patient is unfit, or declines&#xD;
             surgery&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors&#xD;
             (RECIST)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2&#xD;
&#xD;
          -  Estimated life expectancy of at least 12 weeks&#xD;
&#xD;
          -  Capable of giving written informed consent&#xD;
&#xD;
          -  Adequate biliary drainage (serum bilirubin &lt; 2.5 upper limit of normal [ULN]), with no&#xD;
             evidence of active uncontrolled infection (patients on antibiotics are eligible)&#xD;
&#xD;
          -  Women of child-bearing potential with a negative pregnancy test (qualitative serum&#xD;
             human chorionic gonadotropin [HCG]) prior to study entry AND must be using an adequate&#xD;
             contraception method, which must be continued for 1 week after PDT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For locally advanced patients, evidence of metastases other than lung or liver. For&#xD;
             lung metastases, greater than three lesions and any lesions greater than 5 cm are&#xD;
             excluded. For advanced patients, any metastasis is acceptable for enrollment&#xD;
&#xD;
          -  Porphyria&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
&#xD;
          -  Locally advanced disease involving &gt; 50% circumference of the duodenum or a major&#xD;
             artery within the treatment area&#xD;
&#xD;
          -  ECOG performance status 3 or 4&#xD;
&#xD;
          -  Previous treatment with curative intent for current disease within the past two weeks&#xD;
             (i.e. prior resection, radical radiotherapy or chemotherapy)&#xD;
&#xD;
          -  Any psychiatric disorder making reliable informed consent impossible&#xD;
&#xD;
          -  A history of documented hemorrhagic diathesis or coagulopathy on therapeutic&#xD;
             anticoagulation&#xD;
&#xD;
          -  History of prior or concomitant other malignancy that will interfere with the response&#xD;
             evaluation&#xD;
&#xD;
          -  Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in&#xD;
             the view of the investigator makes it undesirable for the patient to participate in&#xD;
             the trial&#xD;
&#xD;
          -  Contrast allergy not amenable to treatment with steroids and antihistamines&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vinay Chandrasekhara</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic in Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Vinay Chandrasekhara, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Verteporfin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03033225
org study id: 16-001243
secondary id: NCI-2019-07003
secondary id: 16-001243
secondary id: P30CA015083
nct id: NCT03033225
lead sponsor: 
collaborator: 
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tumor response
time frame: 12 months post photodynamic therapy (PDT)
description: To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans.
arm group label: Treatment (verteporfin, EUS-guided PDT)
arm group type: Experimental
description: Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
intervention type: Procedure
intervention name: Endoscopic Ultrasound
description: Undergo EUS-guided PDT
arm group label: Treatment (verteporfin, EUS-guided PDT)
other name: endosonography
other name: EUS
intervention type: Procedure
intervention name: Fluorescence Imaging
description: Undergo fluorescence imaging
arm group label: Treatment (verteporfin, EUS-guided PDT)
intervention type: Drug
intervention name: Photodynamic Therapy
description: Undergo EUS-guided PDT
arm group label: Treatment (verteporfin, EUS-guided PDT)
other name: PDT
other name: Photoradiation Therapy
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Treatment (verteporfin, EUS-guided PDT)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Treatment (verteporfin, EUS-guided PDT)
intervention type: Drug
intervention name: Verteporfin
description: Given IV
arm group label: Treatment (verteporfin, EUS-guided PDT)
other name: Benzoporphyrin Derivative Monoacid Ring A
other name: BPD-MA
other name: Visudyne
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vinay Chandrasekhara
role: Principal Investigator
affiliation: Mayo Clinic in Rochester
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Pancreatic Neoplasms
mesh term: Verteporfin