Phase II Study of EUS-guided Verteporfin PDT in Solid Pancreatic Tumors

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 16-001243
    • Rochester, Minnesota: 16-001243
    NCT ID: NCT03033225
    Sponsor Protocol Number: 16-001243

About this study

The goal of project is to target of locally advanced pancreatic cancer (LAPC) with a photodynamic therapy (PDT) to evaluate response of tumor.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Histological/cytological Dx of locally advanced or small volume metastatic PanCa or other solid pancreatic tumor that is not amenable to curative surgical resection, or the patient is unfit, or declines surgery.
  • Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
  • 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 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 HCG) prior to study entry AND must be using an adequate contraception method, which must be continued for 1 week after PDT.

Exclusion Criteria:

  • Evidence of metastases other than lung or liver. For lung metastases, greater than three lesions and any lesions greater than 5cm are excluded.
  • Age < 18 yr; 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 sever 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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Kenneth Wang, M.D.

Closed for enrollment

Contact information:

Frances Cayer CCRP

(904)953-7778

Cayer.Frances@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Wang, M.D.

Open for enrollment

Contact information:

Lori Lutzke CCRP

(507)284-4377

Lutzke.Lori@mayo.edu

More information

Study Progress

This study has completed enrollment of targeted participants and currently is completing research activities including study intervention, specimen collection, testing and data analysis.

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20359598

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