Clareo Health | A Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GenVec
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥18 years old
Patients with unresectable, locally advanced adenocarcinoma of the pancreas proven by biopsy or cytology (defined as direct extension to the SMA and/or celiac axis with absence of a fat plane between the low-density tumor and these arterial structures, or loss of patent superior mesenteric-portal vein confluence), who have not received previous treatment for pancreatic cancer. Patients who have been surgically explored and deemed unresectable on that basis are eligible, provided other entry criteria are met
Informed consent
Karnofsky performance status = or \>70%
Life expectancy greater than 3 months
Measurable disease
You may not be if
Metastatic (stage IV) disease (including involvement of the colon, adrenals, or kidney, or radiographic evidence of peritoneal seeding)
Patients with ascites detected by CT, US or MRI
Patients with bulky celiac adenopathy (i.e., \> 2.5 cm)
Diagnosis of islet cell tumor of the pancreas, lymphoma of the pancreas
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
Previous chemotherapy or radiation for pancreatic cancer or previous radiation to the target field
Liver enzymes \>3 x ULN (ALT, AST, total bilirubin, alkaline phosphatase)
Significant anemia (e.g. hematocrit \<28% or hemoglobin \<9 g/dL) (may have RBC transfusion), or thrombocytopenia (platelet count \<100,000/µL); or neutropenia (ANC \<1500/µL)
Patients with clinically significant pancreatitis within 12 weeks of treatment
Pancreatic pseudocyst
Contraindication to both percutaneous- and endoscopic- guided delivery
Patients with history of deep venous thrombosis or pulmonary embolus
Patients with doppler evidence of deep venous thrombosis at screening
Patients with history of coagulopathy or known thrombophilic disorders
Patients receiving hormone replacement therapy including oral contraceptives within 2 weeks prior to Day 1.
Clinical evidence of active infection of any type, including hepatitis B or C virus
Pregnant or lactating women. It is recommended that both men and women use condoms or another barrier method of birth control for at least 8 weeks following the last administration of TNFerade™ biologic and some form of birth control for at least 1 year
Experimental medications within the last 4 weeks prior to Day 1
Surgery within the last 4 weeks prior to Day 1 (if patient was ambulatory within 48 hours of surgery, patient may be considered eligible)
Chronic systemic corticosteroid use at superphysiologic doses (greater than 10mg prednisone per day or equivalent)
Significant concurrent medical or psychiatric illness which, in the opinion of the investigator, would interfere with the patient's ability to participate in the trial
Please note that there are additional entry criteria. The study center will determine if you meet all criteria. If you do qualify to participate, study personnel will explain the study and answer any questions you may have. You can decide whether or not you wish to participate but if you do not qualify for this trial, study staff will explain the reasons. Please contact your local center listed below, or call the toll free PACT study line for assistance at 1-888-344-6096
