A Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer

February 22, 2012 updated by: GenVec

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States
        • University of California San Diego Moores Cancer Center
      • Los Angeles, California, United States
        • UCLA School of Medicine, Division of Hematology-Oncology
      • Orange, California, United States
        • UC Irvine Medical Center
    • Colorado
      • Denver, Colorado, United States
        • University of Colorado Health Science Center Facility
    • District of Columbia
      • Washington, District of Columbia, United States
        • Georgetown, MedStar Research Institute
    • Florida
      • Tampa, Florida, United States
        • Tampa General Hospital
      • Tampa, Florida, United States
        • H. Lee Moffitt Cancer Center & Research Institute
    • Georgia
      • Atlanta, Georgia, United States
        • Winship Cancer Center, Emory University
    • Illinois
      • Chicago, Illinois, United States
        • The Universtiy of Chicago Medical Center
      • Olympia Fields, Illinois, United States
        • St. James Hospital and Health Centers Comprehensive Cancer Institute
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University Medical Goup
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States
        • Wayne State University, Karmanos Cancer Institute
    • Missouri
      • Kansas City, Missouri, United States
        • Research Medical Center
      • St. Louis, Missouri, United States
        • Washington University
    • New York
      • New York, New York, United States
        • Beth Israel Medical Center, BI Cancer Center
    • North Carolina
      • Greenville, North Carolina, United States
        • Leo W. Jenkins Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States
        • Cancer Centers of the Carolinas
    • Texas
      • Dallas, Texas, United States
        • Mary Crowley Medical Center
      • Dallas, Texas, United States
        • Univeristy of Texas Southwestern Medical Center
      • Houston, Texas, United States
        • Baylor College of Medicine
    • Virginia
      • Richmond, Virginia, United States
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States
        • Virginia Mason Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • University of Wisconsin, Division of Neoplastic Diseases & Related Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenVec

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 10, 2003

First Submitted That Met QC Criteria

January 10, 2003

First Posted (Estimate)

January 13, 2003

Study Record Updates

Last Update Posted (Estimate)

February 23, 2012

Last Update Submitted That Met QC Criteria

February 22, 2012

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GV-001.004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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