Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study

December 29, 2023 updated by: Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (verteporfin, EUS-guided PDT)
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Verteporfin
Given IV
Other Names:
  • Visudyne
  • Benzoporphyrin Derivative Monoacid Ring A
  • BPD-MA
Procedure: Endoscopic Ultrasound
Undergo EUS-guided PDT
Other Names:
  • endosonography
  • EUS
Drug: Photodynamic Therapy
Undergo EUS-guided PDT
Other Names:
  • PDT
  • Photoradiation Therapy
Procedure: Fluorescence Imaging
Undergo fluorescence imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response
Time Frame: 12 months post photodynamic therapy (PDT)
To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans.
12 months post photodynamic therapy (PDT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Vinay Chandrasekhara, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2016

Primary Completion (Actual)

September 20, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

January 24, 2017

First Posted (Estimated)

January 26, 2017

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-001243 (Other Identifier: Mayo Clinic in Rochester)
  • P30CA015083 (U.S. NIH Grant/Contract)
  • NCI-2019-07003 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • P01CA084203 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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