A Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
NCT ID: NCT00051467
Last Updated: 2012-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
Brief Summary
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TNFerade™ is a replication deficient adenovirus vector containing the gene for TNF-alpha controlled by a chemoradiation inducible promoter. This allows the expression of TNF-alpha to be greatest in the area receiving radiation. TNF-alpha is a cytokine that has been shown to have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at effective doses. TNFerade™ Biologic is a novel way of selective delivery of TNF-alpha to tumor cells.
TNFerade™ Biologic will be injected during five weekly injection sessions, concomitant with radiation and 5-FU. TNFerade™ Biologic will be administered by direct intratumoral injection using a percutaneous approach (PTA) or endoscopic ultrasound (EUS).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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TNFerade
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* Coagulopathy (INR \>1.5, PTT ratio \>1.5)
* Renal insufficiency (serum creatinine \>2.0 mg/dL)
* 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
18 Years
ALL
No
Sponsors
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GenVec
INDUSTRY
Responsible Party
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GenVec
Locations
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University of California San Diego Moores Cancer Center
La Jolla, California, United States
UCLA School of Medicine, Division of Hematology-Oncology
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
University of Colorado Health Science Center Facility
Denver, Colorado, United States
Georgetown, MedStar Research Institute
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Winship Cancer Center, Emory University
Atlanta, Georgia, United States
The Universtiy of Chicago Medical Center
Chicago, Illinois, United States
St. James Hospital and Health Centers Comprehensive Cancer Institute
Olympia Fields, Illinois, United States
Indiana University Medical Goup
Indianapolis, Indiana, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Wayne State University, Karmanos Cancer Institute
Detroit, Michigan, United States
Research Medical Center
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
Beth Israel Medical Center, BI Cancer Center
New York, New York, United States
Leo W. Jenkins Cancer Center
Greenville, North Carolina, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Mary Crowley Medical Center
Dallas, Texas, United States
Univeristy of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University of Wisconsin, Division of Neoplastic Diseases & Related Disorders
Milwaukee, Wisconsin, United States
Countries
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References
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Herman JM, Wild AT, Wang H, Tran PT, Chang KJ, Taylor GE, Donehower RC, Pawlik TM, Ziegler MA, Cai H, Savage DT, Canto MI, Klapman J, Reid T, Shah RJ, Hoffe SE, Rosemurgy A, Wolfgang CL, Laheru DA. Randomized phase III multi-institutional study of TNFerade biologic with fluorouracil and radiotherapy for locally advanced pancreatic cancer: final results. J Clin Oncol. 2013 Mar 1;31(7):886-94. doi: 10.1200/JCO.2012.44.7516. Epub 2013 Jan 22.
Other Identifiers
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GV-001.004
Identifier Type: -
Identifier Source: org_study_id
NCT00049647
Identifier Type: -
Identifier Source: nct_alias
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