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

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients 18 years or older.
  • Histological/cytological Dx of advanced or locally advanced or small volume metastatic Pancreatic Cancer 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.
  • For advanced patients, any metastasis is acceptable for enrollment.

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 5cm are excluded. 
  • Age < 18 years old.
  • 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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Wang, M.D.

Open for enrollment

Contact information:

Bryan Linn

(507)255-4631

Linn.Bryan@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions