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Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over Pharmaceutical / Industry GV-001.004 NCT00051467

Trial Description

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).

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

GenVec

U.S.A.
Alabama
	Mobile
	University of South Alabama Mitchell Cancer Institute
		Marion Long	Ph: 251-445-8121
			Email: long@usouthal.edu
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Ann Kolb	Ph: 480-301-4927
			Email: kolb.Ann@mayo.edu
	Tucson
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Amy Kan, MS, CCRC	Ph: 520-694-9065
			Email: ykan@azcc.arizona.edu
California
	Glendale
	Glendale Adventist Medical Center
		Maria Brown, MPH	Ph: 818-409-6687
			Email: brownmt@ah.org
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Kalisha McIntosh	Ph: 858-822-3798
			Email: knmcintosh@ucsd.edu
	Los Angeles
	Jonsson Comprehensive Cancer Center at UCLA
		Nathalie Chorn	Ph: 310-825-4493
			Email: nchorn@mednet.ucla.edu
	USC/Norris Comprehensive Cancer Center and Hospital
		Susan Edwards	Ph: 323-865-0936
			Email: edwards_s@ccnt.usc.edu
		Heinz-Joseph Lenz, M.D.	Principal Investigator
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Sentelle Eubanks	Ph: 714-456-3860
			Email: sentelle@uci.edu
	San Francisco
	San Francisco General Hospital Medical Center
		Sean Hashemi	Ph: 415-206-4630
			Email: HashemiS@sfghsurg.ucsf.edu
Colorado
	Denver
	University of Colorado Cancer Center at UC Health Sciences Center
		Maximiliano Smolkin	Ph: 303-724-1872
			Email: maximiliano.smolkin@uchsc.edu
District of Columbia
	Washington
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		Lisa Ley	Ph: 202-687-6653
			Email: leyl@georgetown.edu
Florida
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Tiffany Campos	Ph: 813-745-8358
			Email: Tiffany.campos@moffitt.org
	Tampa General Hospital
		Jennifer Cooper	Ph: 813-844-4218
			Email: jcooper@hsc.usf.edu
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Ira Blount	Ph: 404-778-4449
			Email: iblount@emory.edu
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Sharone Kaplan	Ph: 773-702-3712
			Email: skaplan@surgery.bsd.uchicago.edu
	University of Illinois Cancer Center
		Sandee Bernklau, MSN, RN	Ph: 312-413-0223
			Email: sbern@uic.edu
	Olympia Fields
	Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
		Maureen McGlashan	Ph: 708-747-4000
			Email: maureen.mcglashan@ssfhs.org
Indiana
	Indianapolis
	Indiana University Medical Goup
		Kathleen McGreevy, RN	Ph: 317-274-5392
			Email: kmcgreev@iupui.edu
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Rebecca Shelton
			Email: rshel1@email.uky.edu
Louisiana
	Alexandria
	Christus St. Francis Cabrini Hospital,Cabrini Center for Cancer Care
		Tammy DeBona	Ph: 318-448-6973
			Email: tammy.debona@christushealth.org
		Steven Saccaro	Principal Investigator
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Beth Griffith	Ph: 410-502-9253
			Email: bgriffit@jhmi.edu
Massachusetts
	Boston
	Beth Israel Deaconess Medical Center
		Megan Healy	Ph: 617-667-1943
			Email: mehealy@bidmc.harvard.edu
Michigan
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Ann Marie Ferris, RN, BSN, CCRP	Ph: 313-576-9373
			Email: ferrisa@karmanos.org
Missouri
	Kansas City
	Research Medical Center
		Jennifer Otto	Ph: 816-276-4227
			Email: jennifer.otto@hcamidwest.com
	St. Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Brandi Simmons	Ph: 314-747-4112
			Email: simmonsb@ccadmin.wustl.edu
Montana
	Billings
	Billings Clinic Cancer Center
		Joan Kock	Ph: 406-238-2109
			Email: JKoch@billingsclinic.org
New York
	New York
	Beth Israel Medical Center - Petrie Division
		Sherly Jacob-Perez	Ph: 212-844-8292
			Email: sjacob@chpnet.org
	Mount Sinai Medical Center
		Eugene Akahoho	Ph: 212-824-7310
			Email: eugene.akahoho@mssm.edu
North Carolina
	Greenville
	Leo W. Jenkins Cancer Center at ECU Medical School
		Denise Brigham, RN	Ph: 252-744-5267
			Email: brigham@ecu.edu
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Shelley Robinson	Ph: 216-444-9668
			Email: robinss@ccf.org
Oregon
	Portland
	Legacy Clinical Research and Technology Centerr
		Aaron White	Ph: 503-413-7202
			Email: ajwhite@lhs.org
	Portland Providence Medical Center
		Katie Strauss	Ph: 503-215-2619
			Email: katie.strauss@providence.org
South Carolina
	Charleston
	Charleston Cancer Center
		Debi Craft, BS, RN, CCRC	Ph: 843-576-1006
			Email: debi.craft@charlestonCancer.com
	Greenville
	Cancer Centers of the Carolinas - Eastside
		Julie Martin, APRN, NP	Ph: 864-679-3966
			Email: julie.martin@usoncology.com
Texas
	Dallas
	Mary Crowley Medical Research Center at Sammons Cancer Center
		Jim Eamma	Ph: 214-658-1945
			Email: jeamma@mcmrc.com
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Dendra Vonmerveldt	Ph: 214-648-5107
			Email: entra.vonmerveldt@utsouthwestern.edu
	Houston
	Dan L. Duncan Cancer Center at Baylor College of Medicine
		Glenn Wilson	Ph: 713-798-3468
			Email: ggwilson@bcm.tmc.edu
Virginia
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Diane Holdford, RN, BSN, CCRC	Ph: 804-828-0296
			Email: djholdfo@hsc.vcu.edu
Washington
	Seattle
	Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center
		Jody C Mooney, MS	Ph: 206-341-1452
			Email: jody.mooney@vmmc.org
Wisconsin
	Marshfield
	CCOP - Marshfield Clinic Research Foundation
		Cindy Coakley	Ph: 715-221-7281
			Email: coakley.cindy@mcrf.mfldclin.edu
	Milwaukee
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Brenda Davies	Ph: 414-805-4639
			Email: bdavies@mcw.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00051467
Information obtained from ClinicalTrials.gov on September 30, 2008