Open-label, Single-center, Non-randomized, Phase I, Dose-ranging Study of Endoscopic Ultrasound (EUS) Guided Photodynamic Therapy (PDT) With Photofrin® in Locally Advanced Pancreatic Cancer

Inclusion Criteria:

- Unresectable, locally advanced measurable (at least bidirectional) adenocarcinoma of
the pancreas (regardless of site) proven by biopsy or cytology and confirmed by
surgical consultation

- Informed consent and authorization for the release of health information signed by
the patient

- Karnofsky performance status >= 70%

- Life expectancy >= 3 months

- Females of childbearing potential and males must use an effective method of
contraception

Exclusion Criteria:

- Metastatic (stage IV) disease (including involvement of the colon, adrenals, or
kidney, or radiographic evidence of peritoneal seeding or pulmonary metastases)

- Previous chemotherapy, radiotherapy of other treatment for PC

- Gastric or duodenal wall invasion by the primary PC as assessed by CT or MRI and EUS
staging

- Gastric or duodenal ulcer (at least 10 mm in size) within 10 mm of expected endoscopy
puncture site(s) for PDT

- Esophageal or gastric varices

- Cystic component >= 25% the total volume of the tumor

- Ascites detected by CT, ultrasound (US) or MRI; (trace ascites will not be an
exclusion)

- Bulky celiac adenopathy (i.e., >= 2.5 cm in diameter)

- Diagnosis of islet cell tumor, lymphoma, metastatic lesion, acinar cell (or other
atypical pathologic malignancy)

- History of other malignancy in the past 2 years except carcinoma in situ of the
cervix or bladder, non-melanomatous skin cancer or localized/early stage prostate
cancer

- Unable to receive or previously intolerant of moderate and/or deep sedation

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >= 3 x upper
limit of normal (ULN)

- Total bilirubin >= 3 x ULN

- Alkaline phosphatase >= 3 x ULN

- International normalized ratio (INR) >= 1.5

- Partial thromboplastin time (PTT) ratio >= 1.5

- Serum creatinine >= 2.0 mg/dL

- Hematocrit =< 28% or hemoglobin =< 9 g/dL, but may have red blood cell (RBC)
transfusion

- Platelet count =< 100,000/microliter (uL)

- Absolute neutrophil count (ANC) =< 1500/uL

- Clinically significant pancreatitis within 12 weeks of treatment with protocol
therapy

- Contraindication to EUS-guided needle puncture into the pancreas

- History of coagulopathy or known thrombophilias

- Use of anticoagulants that cannot be discontinued both 5 days before and 5 days after
EUS

- Clinical evidence of active infection of any type, including hepatitis B or C virus

- Pregnant or lactating women

- Experimental medications within the last 4 weeks prior to day 1

- Any surgery (including diagnostic laparoscopy and/or biliary +/- duodenal palliative
bypass for inoperable PC) within the 2 weeks prior to day 1 of study protocol

- Chronic systemic corticosteroid use at superphysiologic doses (>= 10 mg prednisone
per day or equivalent)

- Inability to avoid exposure of skin or eyes to direct sunlight or bright indoor light
for at least 30 days

- Porphyria

- Inability to obtain venous access in the antecubital region to administer PHO or
sedation for endoscopy procedures

- Significant concurrent medical or psychiatric illness which, in the opinion of the
principal investigator would interfere with trial participation