A Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
A Randomized, Phase II/III, Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-line Treatment of Unresectable Locally Advanced Pancreatic Cancer
1 other identifier
interventional
N/A
1 country
25
Brief Summary
The primary purpose of this study is to assess the safety and effectiveness of TNFerade™ Biologic when administered concurrently with 5-FU and radiation therapy as first-line treatment of unresectable locally advanced pancreatic cancer. 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).
Trial Health
Trial Health Score
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25 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2003
CompletedFirst Posted
Study publicly available on registry
January 13, 2003
CompletedFebruary 23, 2012
May 1, 2011
January 10, 2003
February 22, 2012
Conditions
Interventions
Eligibility Criteria
You may qualify 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 qualify 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)
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GenVeclead
Study Sites (25)
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
Related Publications (1)
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.
PMID: 23341531DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 10, 2003
First Posted
January 13, 2003
Last Updated
February 23, 2012
Record last verified: 2011-05