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

This study has been completed.
Sponsor:
Information provided by:
GenVec
ClinicalTrials.gov Identifier:
NCT00051467
First received: January 10, 2003
Last updated: February 22, 2012
Last verified: May 2011
  Purpose

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).


Condition Intervention Phase
Pancreatic Cancer
Genetic: TNFerade
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GenVec:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051467

  Show 25 Study Locations
Sponsors and Collaborators
GenVec
  More Information

No publications provided by GenVec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul Fischer, PhD, GenVec
ClinicalTrials.gov Identifier: NCT00051467     History of Changes
Obsolete Identifiers: NCT00049647
Other Study ID Numbers: GV-001.004
Study First Received: January 10, 2003
Last Updated: February 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 30, 2014