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

Overview

Información sobre este estudio

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

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Vinay Chandrasekhara, M.D.

Cerrado para la inscripción

Contact information:

Bryan Linn

(507)255-4631

Linn.Bryan@mayo.edu

More information

Publicaciones

Publications are currently not available
.
CLS-20359598

Mayo Clinic Footer