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Immunotherapy Study for Surgically Resected Pancreatic Cancer

This study is currently recruiting participants.
Verified April 2013 by NewLink Genetics Corporation
Sponsor:
Information provided by (Responsible Party):
NewLink Genetics Corporation
ClinicalTrials.gov Identifier:
NCT01072981
First received: February 18, 2010
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to assess overall survival after treatment with a regimen of adjuvant therapy (Gemcitabine alone or with 5-FU chemoradiation) with or without HyperAcute®-Pancreas (algenpantucel-L) immunotherapy in subjects who have undergone surgical resection.


Condition Intervention Phase
Pancreatic Cancer
 Biological: HyperAcute-Pancreas Immunotherapy
Drug: Gemcitabine
Radiation: 5FU Chemoradiation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without HyperAcute®-Pancreas (Algenpantucel-L) Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NewLink Genetics Corporation:

Primary Outcome Measures:
  • The primary objective is to assess overall survival [ Time Frame: Approximately 41 months and 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective is to assess disease free survival and to conduct correlative scientific studies of subject samples to determine the mechanism of any observed anti-tumor effect. [ Time Frame: Approximately 41 months and 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 722
Study Start Date: April 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HyperAcute-Pancreas Immunotherapy + Standard of Care
*Adjuvant Standard of Care Treatment (SOC) consisting of gemcitabine with or without 5FU chemoradiation + HyperAcute Immunotherapy
 Biological: HyperAcute-Pancreas Immunotherapy
Up to 18 immunizations of 300 million immunotherapy cells
Other Name: HAPa-1 and HAPa-2 immunotherapy components
Drug: Gemcitabine
Gemcitabine 1000 mg/m2/day once a week for 3 weeks
Other Name: Gemzar
Radiation: 5FU Chemoradiation
5FU 200-250 mg/m2/day over 5 1/2 weeks with radiation.
Other Name: Fluorouracil
Active Comparator: Standard of Care alone
*Adjuvant Standard of Care Treatment (SOC) consisting of gemcitabine with or without 5FU chemoradiation Alone
 Drug: Gemcitabine
Gemcitabine 1000 mg/m2/day once a week for 3 weeks
Other Name: Gemzar
Radiation: 5FU Chemoradiation
5FU 200-250 mg/m2/day over 5 1/2 weeks with radiation.
Other Name: Fluorouracil

  Hide Detailed Description

Detailed Description:

Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most patients diagnosed with pancreatic cancer continue to die from the rapid progression of their disease. The primary reason for this is that the disease is typically without symptoms until significant local and/or distant spread has occurred and is often beyond the chance for cure at the time of the diagnosis. The lack of any treatment to significantly increase long term survival rates is reflected by the poor outcomes associated with this disease, specifically time to disease progression and overall survival.

These disappointing facts typically shape discussions of treatment options for patients with this disease. However, another important part of the body is now being looked at as a target for therapy against this disease -- the immune system. Scientists have clearly shown that pancreatic tumor cells produce a number of defective proteins, or express normal proteins in highly uncharacteristic ways, as part of this cancer. In some cancers, these abnormalities can cause an immune response to the cancer cells much in the way one responds to infected tissue. In progressive cancers however, the immune system fails to identify or respond to these abnormalities and the cancer cells are not attacked or destroyed for reasons not yet fully understood. This clinical trial proposes a new way to stimulate the immune system to recognize the abnormal components found in pancreatic cancer cells and to stimulate an immune response that destroys or blocks the growth of the cancer.

This new method of treatment helps the immune system of pancreatic cancer patients to "identify" the cancerous tissue so that it can be eliminated from the body. As an example, most people are aware that patients with certain diseases may require an organ transplant to replace a damaged kidney or heart. After receiving their transplant these patients receive special drugs because they are at great danger of having an immune response that destroys or "rejects" the transplanted organ. This "rejection" occurs when their immune system responds to differences between the cells of the transplanted organ and their own immune system by attacking the foreign tissue in the same way as it would attack infected tissue. When the differences between foreign tissues and the patient's body are even larger, perhaps like differences between organs from pigs and the immune system cells of humans, the rejection is very rapid, highly destructive and the immunity it generates is long lasting. This is called hyperacute rejection and the medicine used to immunize patients in this protocol tries to harness this response to teach a patient's immune system to fight their pancreatic cancer just as the body would learn to reject a transplanted organ from an animal.

To do this, the investigators have placed a mouse gene into human pancreatic cancer cells so that the immune system will easily recognize them as foreign, stimulating the patient immune system to attack the vaccine cells just as they would any other animal cells. As part of the process of destroying the immunotherapy cells, the patient immune system is stimulated to identify as many differences from normal human as possible. This extra stimulation is thought to encourage immune responses against the pancreatic cancer in the patient based on shared abnormalities of pancreatic cancer vaccine cells and the patient's pancreatic cancer cells.

In this experimental therapy, patients are given injections of an immunotherapy consisting of two types of cancer cells that the investigators have modified to make them more easily recognized and attacked by the immune system. The investigators propose to test this new treatment in patients with pancreatic cancer who have undergone tumor removal surgery but remain at extremely high risk of disease progression to demonstrate that treatment with the immunotherapy increases the time until the tumor recurs or increases overall survival when given in combination with the current standard of care therapy for this disease.

For more information, please see our study specific website: www.pancreaticcancer-clinicaltrials.com

  Eligibility

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

Inclusion Criteria:

  • A histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology.
  • American Joint Committee on Cancer (AJCC) Stage I or II Pancreatic carcinoma. Patients must have undergone surgical resection for the tumor and extent of resection must be either R0 (complete resection with grossly and microscopically negative margins of resection) or R1 (grossly negative but positive microscopically margins of resection).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
  • Serum albumin ≥2.0 gm/dL.
  • Expected survival ≥6 months.
  • Subjects must be able to take in adequate daily calorie intake based on judgment of clinical investigator.
  • Adequate organ function including:
  • A. Marrow: white blood cells (WBC) ≥3000/mm3 and platelets ≥100,000/mm3.
  • B. Hepatic: serum total bilirubin ≤2 x ULN mg/dL, ALT (SGPT) and AST (SGOT) ≤3 x upper limit of normal (ULN).
  • C. Renal: serum creatinine (sCr) ≤2.0 x ULN, or creatinine clearance (Ccr) ≥30 mL/min.
  • First vaccination must be within 10 weeks after surgery.
  • Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
  • All subjects of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product, and for one month after the last immunization.

Exclusion Criteria:

  • Age <18-years-old.
  • Active metastases. Suspicious lesions on CT scans must be reviewed by a second, different reviewer. If active disease not ruled out by second, different reviewer (at clinical institution), a positron emission tomography (PET) CT or further imaging tests or histology may be needed to rule out disease before enrollment is allowed.
  • Other malignancy within five years, unless the probability of recurrence of the prior malignancy is <5% as determined by the Principal Investigator based on available information. Patient's curatively treated for squamous and basal cell carcinoma of the skin or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.
  • History of organ transplant.
  • Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
  • Subjects taking chronic systemic corticosteroid therapy for any reason are not eligible. Subjects may receive steroids as prophylactic anti-emetics, not to exceed 10 mg Decadron weekly. Subjects may also receive pulse doses for Gemcitabine hypersensitivity, not to exceed Decadron 8 mg twice a day (BID) x 3 days prior to start day of Gemcitabine. Subjects receiving inhaled or topical corticosteroids are eligible. Subjects who require chronic systemic corticosteroids after beginning vaccination, will be removed from study.
  • Significant or uncontrolled congestive heart failure (CHF),myocardial infarction or significant ventricular arrhythmias within the last six months.
  • Active infection or antibiotics within 48 hours prior to study,including unexplained fever (temp > 38.1C).
  • Autoimmune disease (e.g., systemic lupus erythematosis (SLE), rheumatoid arthritis (RA), etc.). Patients with a remote history of asthma or mild active asthma are eligible.
  • Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis) or a serious illness in medical opinion of the clinical investigator.
  • Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc.).
  • A known allergy to any component of the HyperAcute® immunotherapy.
  • Pregnant or nursing women due to the unknown effects of vaccination on the developing fetus or newborn infant. (For patients with child bearing potential, a βHCG must be completed within 14 days of first vaccination).
  • Known HIV positive.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072981

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35249
Contact: Sharon Barkley, RN, BSN     205-975-2008     sharon.barkley@ccc.uab.edu    
Principal Investigator: James Posey, MD            
University of South Alabama Recruiting
Mobile, Alabama, United States, 36604
Contact: Pam Francisco     251-445-9870     pfrancisco@usouthal.edu    
Principal Investigator: William Taylor, M.D.            
United States, Arizona
Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Laura Pestana     520-694-9060     LPestana@azcc.arizona.edu    
Principal Investigator: Emad Elquza, MD            
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Trent Trice     501-686-8274     TMTrice@uams.edu    
Principal Investigator: Issam Makhoul, MD            
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Carol Rose     626-256-4673 ext 62845     crose@coh.org    
Principal Investigator: Vincent Chung, MD            
University of Southern California Active, not recruiting
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Laura Sarmiento, CCRC     310-423-4295     Laura.Sarmiento@cshs.org    
Principal Investigator: Nicholas Nissen, MD            
Stanford Cancer Center Recruiting
Palo Alto, California, United States, 94304
Contact: Donna Williams, RN     650-498-6608     donnacw@stanford.edu    
Principal Investigator: George Fisher, MD            
Sutter Institute for Medical Research Recruiting
Sacramento, California, United States, 95816
Contact: Dan Popescu     916-453-5807     PopescDS@sutterhealth.org    
Principal Investigator: Stacey D'Andre, MD            
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Laurel Fiske     415-600-1654     FiskeL@cpmcri.org    
Principal Investigator: Ari Baron, M.D.            
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Kirsten Miller     720-848-5278     Kirsten.miller@ucdenver.edu    
Principal Investigator: Colin Weekes, MD            
United States, Connecticut
Stamford Hospital Recruiting
Stamford, Connecticut, United States, 06902
Contact: Ed Hatton, RN, BSN     203-964-1641     EHatton@stamhealth.org    
Principal Investigator: Salvatore Del Prete, MD            
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Lisa Ley, RN     202-687-6653     leyl@georgetown.edu    
Principal Investigator: John Marshall, MD            
United States, Florida
Boca Raton Hospital Recruiting
Boca Raton, Florida, United States, 33486
Contact: Sylvie Godbout, RN, BSN     561-955-4539     sgodbout@brrh.com    
Principal Investigator: Warren Brenner, M.D.            
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Alison Ivey     352-265-0680 ext 88411     aivey@ufl.edu    
Principal Investigator: Thomas George, M.D.            
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Mayo Clinic Clinical Trials Office     507-538-7623        
Principal Investigator: George Kim, MD            
Lakeland Regional Cancer Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Robin S Stewart, RN, PhD, OCN     863-904-1877     robin.stewart@lrmc.com    
Principal Investigator: Manuel Molina, MD            
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Kamara Mertz-Rivera, MA, CCRC     305-243-0862     k.mertz-rivera@med.miami.edu    
Principal Investigator: Caio M. Rocha Lima, MD            
USF Tampa General Recruiting
Tampa, Florida, United States, 33606
Contact: Elizabeth Downs, CRC     813-844-8540     edowns1@health.usf.edu    
Principal Investigator: Vic Velanovich, MD            
MOFFITT Recruiting
Tampa, Florida, United States, 33612
Contact: Helen Jump     813-745-4834     Helen.jump@moffitt.org    
Principal Investigator: Gregory Springett, MD            
United States, Illinois
Illinois Cancer Specialists Recruiting
Arlington Heights, Illinois, United States, 60005
Contact: Heather Lee, RN, BSN, OCN     847-259-0624     heather.lee@usoncology.com    
Principal Investigator: Randy Rich, MD            
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Patricia Kartcheske     312-695-1376     patricia.kartcheske@northwestern.edu    
Principal Investigator: Mary Mulcahy, MD            
Northshore University Health Systems Recruiting
Evanston, Illinois, United States, 60201
Contact: Tara Flanagan, RN, BSN     847-570-1768     TFlanagan@northshore.org    
Principal Investigator: Jennifer Obel, MD            
Edward H. Kaplan, MD and Associates Recruiting
Skokie, Illinois, United States, 60076
Contact: Marsha Weller     847-675-3900     mregwell@yahoo.com    
Principal Investigator: Edward H Kaplan, MD            
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: John A Spittler     317-274-0771     ajspittl@iupui.edu    
Principal Investigator: Romnee Clark, MD            
Investigative Clinical Research of Indiana, LLC Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Leslie Weitman     317-297-2208     leslieweitman@sbcglobal.net    
Principal Investigator: Robert Manges, MD            
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Michelle Arnold, RN, OCN     319-356-2778     michelle-arnold@uiowa.edu    
Principal Investigator: Daniel J. Berg, MD            
United States, Kansas
University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Ashley Shores, MEd     913-588-1897     ashores@kumc.edu    
Principal Investigator: Stephen Williamson, MD            
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Randi Eden     502-629-3384     rkeden01@louisville.edu    
Principal Investigator: Charles Scoggins, MD            
United States, Louisiana
Mary Bird Perkins Cancer Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Donna Holmes, CCRC     225-215-1185     dholmes@marybird.com    
Principal Investigator: Bryan Bienvenu, MD            
Ochsner Cancer Institute Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Michelle Cronin, RN, BSN, OCN     504-842-3708     micronin@ochsner.org    
Principal Investigator: Charles Conway, MD            
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Jagdish Shetty, CCRP     410-328-7680     jshetty@umm.edu    
Principal Investigator: Nader Hanna, MD            
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Emma Breault     617-667-5984     ebreault@bidmc.harvard.edu    
Principal Investigator: Rebecca Miksad, MD, MPH            
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: GI Research     617-632-5960        
Principal Investigator: Peter Enzinger, MD            
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Susan Sheehan, RN     617-724-9437     SSHEEHAN1@PARTNERS.ORG    
Principal Investigator: Cristina Ferrone, MD            
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Deb Gannon     781-744-2734     deborah.j.gannon@lahey.org    
Principal Investigator: Francis Nugent, M.D.            
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Vy Le, CCRP     734-936-9238     thuyvy@med.umich.edu    
Principal Investigator: Mark M Zalupski, MD            
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Sandy Alexander, RN ADS     313-916-8006     salexan4@hfhs.org    
Principal Investigator: Kellie McFarlin, MD            
Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Ingrid Tibbits, RN,BSN,CCRP     248-551-6935     itibbits@beaumont.edu    
Principal Investigator: Laura Nadeau, MD            
United States, Minnesota
Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55409
Contact: Lisa Albers, RN,CCRC     612-863-9466     lisa.albers@allina.com    
Principal Investigator: John Seng, MD            
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Office     507-538-7623        
Principal Investigator: Robert R McWilliams, MD            
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65203
Contact: Chris Ehlenbeck     573-884-7488     ehlenbeckc@health.missouri.edu    
Principal Investigator: Michael Nicholl, MD            
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Laura Daigh     314-286-0707     daighl@wudosis.wustl.edu    
Principal Investigator: William Hawkins, MD            
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Jolene M. Tijerina, RN, BSN     402-559-8711     jolene.tijerina@unmc.edu    
Principal Investigator: Jean Grem, MD            
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Kim Steinberg     505-925-0378     kimsteinberg@salud.unm.edu    
Principal Investigator: Fa-Chyi Lee, MD            
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Prerna Chopra     212-241-4863     prerna.chopra@mountsinai.org    
Principal Investigator: Daniel Labow, MD            
Columbia University Active, not recruiting
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Anthony Amara, MSW     919-668-1861     anthony.amara@duke.edu    
Principal Investigator: Michael Morse, MD            
Wake Forest Baptist Health Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Joyce Fenstermaker, RN     336-713-3155     jfenster@wakehealth.edu    
Principal Investigator: Perry Shen, MD            
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Patricia Rose, RN, BSN     513-584-2606     ROSEPI@UCMAIL.UC.EDU    
Principal Investigator: Olugbenga Olowokure, MD            
University Hospitals Case Western Recruiting
Cleveland, Ohio, United States, 44106
Contact: Laura Balint     216-983-3229     laura.balint@UHhospitals.org    
Principal Investigator: Jeffrey Hardacre, MD            
Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Hamida Umar     614-685-6406     Hamida.umar@osumc.edu    
Principal Investigator: Tanios Bekaii-Saab, MD            
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Bronwyn Bennett     405-271-4022     Bronwyn-bennett@ouhsc.edu    
Principal Investigator: Shubham Pant, MD            
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Caron Campbell, RN     503-494-8699     campbcar@ohsu.edu    
Principal Investigator: Gina Vaccaro, MD            
United States, Pennsylvania
St. Luke's Hospital and Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Denise Dianna     484-503-4152     diannad@slhn.org    
Principal Investigator: Darius Desai, MD            
Penn State Hershey Cancer Institute Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: JoAnn Fahringer     717-531-0003 ext 285237     jfahringer@hmc.psu.edu    
Principal Investigator: Niraj Gusani, MD            
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Rebecca Marlow, RN, BSN, MBA     215-214-1451     becky.marlow@fccc.edu    
Principal Investigator: Steven Cohen, M.D.            
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Sharon Molotsky     215-955-9359     sharon.molotsky@jefferson.edu    
Principal Investigator: Harish Lavu, MD            
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Anja Jones, MS     215-349-8152     anja.jones@uphs.upenn.edu    
Principal Investigator: Ursina R Teitelbaum, MD            
University of Pittsburg Medical Center Recruiting
Pittsburg, Pennsylvania, United States, 15232
Contact: Kristen Maurer     412-235-1317     maurerks@upmc.edu    
Principal Investigator: Herbert Zeh, MD            
United States, Rhode Island
Roger Williams Medical Center Recruiting
Providence, Rhode Island, United States, 02908
Contact: Frances Dallesandro     401-456-2698     fdallesandro@chartercare.org    
Principal Investigator: N. Joseph Espat, MD            
United States, South Carolina
Cancer Center of the Carolinas Recruiting
Greenville, South Carolina, United States, 29615
Contact: Gina Norris     864-242-2762     gina.norris@usoncology.com    
Principal Investigator: Ki Young Chung, MD            
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Tyson Dudley     214-648-7031     tyson.dudley@utsouthwestern.edu    
Principal Investigator: John C. Mansour, MD            
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Glenn Wilson     713-798-3468     ggwilson@bcm.tmc.edu    
Principal Investigator: William Fisher, MD            
Ben Taub Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Carolyn Thibodeaux     713-798-4797     carolynt@bcm.edu    
Principal Investigator: William Fisher, M.D.            
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Darrel Cleere, RN, CCRP     713-441-6232     dwcleere@tmhs.org    
Principal Investigator: Craig Fisher, M.D.            
Joe Arrington Cancer Research and Treatment Center Recruiting
Lubbock, Texas, United States, 79410
Contact: Dawn Howerton, RN, OCN     806-725-7994     dhowerton@covhs.org    
Principal Investigator: Isaac Tafur, MD            
University of Texas Health Sciences Recruiting
San Antonio, Texas, United States, 78229
Contact: Leslie Wood, RN,BSN,OCN     210-450-5962     woodl3@uthscsa.edu    
Principal Investigator: Devalingam Mahalingam, MD            
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Sasha White     434-982-1902     snw2z@virginia.edu    
Principal Investigator: Reid Adams, MD            
Lynchburg Hematology-Oncology Clinic, Inc. Recruiting
Lynchburg, Virginia, United States, 24501
Contact: Donna Washburn     434-200-1495     donna.washburn@centrahealth.com    
Principal Investigator: Kathleen Paul, MD            
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Marcia Megginson     804-628-0616     mmegginson@vcu.edu    
Principal Investigator: James Shaw, MD            
United States, Washington
University of Washington- Seattle Cancer Center Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Grace Gyurkey     206-288-7603     ggyurkey@seattlecca.org    
Principal Investigator: Andrew Coveler, MD            
United States, Wisconsin
Vince Lombardi Cancer Clinic Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Kate Newbanks     920-288-4115     kate.newbanks@aurorabaycare.com    
Principal Investigator: Dhimant Patel, MD            
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Deb Gawin, RN     608-265-9138     gawin@surgery.wisc.edu    
Principal Investigator: Clifford Cho, MD            
Sponsors and Collaborators
NewLink Genetics Corporation
Investigators
Study Director: Nicholas N Vahanian, M.D. NewLink Genetics Corporation
  More Information

Additional Information:
Study Specific Web Site  This link exits the ClinicalTrials.gov site

No publications provided by NewLink Genetics Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: NewLink Genetics Corporation
ClinicalTrials.gov Identifier: NCT01072981     History of Changes
Other Study ID Numbers: NLG0405, OBA# 0912-1013
Study First Received: February 18, 2010
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by NewLink Genetics Corporation:
Pancreatic Cancer
Vaccine Therapy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Gemcitabine
Pancreatin
Pancrelipase
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 16, 2013