Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-Metastatic, Post-Resection Pancreas Cancer

Condition(s) targeted: Pancreas Cancer

Intervention: GI-4000 (Biological); Gemcitabine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: GlobeImmune

Overall contact:
John Ferraro, Phone: 303-625-2733

The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.

Official title: A Phase 2 Double-Blind, Placebo Controlled, Multi-Center Adjuvant Trial of the Efficacy, Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein Combined With a Gemcitabine Regimen Versus a Gemcitabine Regimen With Placebo, in Patients With Post-Resection R0/R1 Pancreatic Cancer With Tumor Sequence Confirmation of Ras Mutations.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Recurrence free time and survival

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

(A few general items required)

Inclusion Criteria:

- Patients with non-metastatic pancreas cancer post-resection that have a

product-related ras mutation

- >18 years of age

- Negative skin test for hypersensitivity to Saccharomyces cerevisiae

Exclusion Criteria:

- Metastatic pancreas cancer patients post-resection

- Patients with no product-related ras mutation.

John Ferraro, Phone: 303-625-2733

G B Pan Hospital & Maulana Azad Medical College, New Delhi 110002, India; Recruiting
Anil Agarwal, MD, Phone: 011.23235702
Anil Agarwal, MD, Principal Investigator

Regional Cancer Centre, Trivandrum 695011, India; Recruiting
Jayaprakash Madhavan, MD, Phone: 91472522334
Jayaprakash Madhavan, MD, Principal Investigator

Govt Medical Colleg & Hospital, Nagpur, India; Recruiting
Krishna Kamble, MD, Phone: 9850246175
Krishna Kamble, MD, Principal Investigator

Lifeline Multispecialty Hospital, Perungudi, Chennai 600096, India; Recruiting
J S Rajkumar, MD, Phone: 04442454545
J S Rajkumar, MD, Principal Investigator

KMC Hospital, Mangalore 575001, India; Recruiting
Srirama Bhat, MD, Phone: 9243302052, Email: Meera_sriram2003@yahoo.com
Srirama Bhat, MD, Principal Investigator

Lake Shore Hospital & Research Centre, Nettoor, Cochin 682304, India; Recruiting
Hariharan Ramesh, MD, Phone: 04842701032, Email: gangvp@md4.vsnl.net.in
Hariharan Ramesh, MD, Principal Investigator

Indo American Cancer Hospital and Research Centre, Hyderabad 500034, India; Recruiting
Nirni Sharanabasappa Somanath, MD, Phone: 04023551235
Nirni Sharanabasappa Somanath, MD, Principal Investigator

Nizam's Institute of Medical Sciences, Panjagutta, Hyderaba 500082, India; Recruiting
Nagari Bheerappa, MD, Phone: 09949092298
Nagari Bheerappa, MD, Principal Investigator

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States; Recruiting
Dayle Craig, Phone: 205-975-8080, Email: dayle.craig@ccc.uab.edu
J. Pablo Arnoletti, MD, Principal Investigator

University of Arizona Cancer Center, Tucson, Arizona 85724, United States; Recruiting
Susan Jordan, Phone: 520-694-9056, Email: sjordan@azcc.arizona.edu
Michael J Demeure, MD, FACS, Principal Investigator

Hematology Oncology Associates, Phoenix, Arizona 85012, United States; Active, not recruiting

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States; Recruiting
Ann Cato, Phone: 501-686-8274, Email: catocann@uams.edu
Rangaswamy Govindarajan, MD, Principal Investigator

University of California San Diego, LaJolla, California 92093, United States; Recruiting
Kirsten Loureiro, MPH, Phone: 858-822-5366, Email: kloureiro@ucsd.edu
Tony Reid, MD, Principal Investigator

UCLA Medical Center, Los Angeles, California 90095, United States; Recruiting
Myung Lee, Phone: 310-825-4494, Email: mylee@mednet.ucla.edu
Edward Garon, MD, Principal Investigator

Tower Cancer Research Foundation, Beverly Hills, California 90211, United States; Recruiting
Linda Ford, Email: fordl@toweroncology.com
Peter J. Rosen, MD, Principal Investigator

Rocky Mountain Cancer Centers, Denver, Colorado 80218, United States; Recruiting
Janette Stalemo, Phone: 303-285-5081, Email: janette.stalemo@usoncology.com
Allen Cohn, MD, Principal Investigator

Georgetown University Medical Center / Lombardi Cancer Center, Washington, District of Columbia 20007, United States; Recruiting
Lisa Ley, RN, MS, Phone: 202-687-6653, Email: leyl@georgetown.edu
John L Marshall, MD, Principal Investigator

Cancer Centers of Florida, PA, Ocoee, Florida 34761, United States; Active, not recruiting

Straub Clinic and Hospital, Honolulu, Hawaii 96813, United States; Active, not recruiting

Rush University Medical School, Chicago, Illinois 60612, United States; Not yet recruiting
Linda Polzin, RNA, MBA, Phone: 312-942-3608, Email: linda_k_polzin@rush.edu
Terry O'Brien, RN, BS, OCN, Phone: 312-942-5689
Jante Plate, PhD, Principal Investigator

William Beaumont Hospital, Royal Oak, Michigan 48073, United States; Recruiting
Ingrid K Tibbits, RN, BSN, OCN, Phone: 248-551-6935, Email: itibbits@beaumont.edu
Ishmael A Jaiyesimi, DO, FACP, Principal Investigator

Minnesota Oncology Hematology, PA, Minneapolis, Minnesota 55404, United States; Recruiting
Lynn Anderson, RN, Phone: 952-928-2992, Email: lynn.anderson@usoncology.com
Patrick J Flynn, MD, Principal Investigator

Washington University, St. Louis, Missouri 63110, United States; Recruiting
Chloe Fournier, RN, Phone: 314-747-4235, Email: cfournie@im.wustl.edu
Joel Picus, MD, Principal Investigator

Missouri Cancer Centers, Columbia, Missouri 65201, United States; Active, not recruiting

St. Joseph Oncology, Inc., St. Joseph, Missouri 64507, United States; Active, not recruiting

New York Oncology Hematology, PC, Albany, New York 12208, United States; Active, not recruiting

State University of NY at Stony Brook, Stony Brook, New York 11794, United States; Recruiting
Kim Lyktey, RN OCN CCRC, Phone: 631-638-0846, Email: krauso@notes.cc.sunysb.edu
Martin S Karpeh, MD, Principal Investigator

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina 27599, United States; Recruiting
Judy Maloney, RN BSN OCN, Phone: 919-966-4432, Email: judith_maloney@med.unc.edu
Bert O'Neil, MD, Principal Investigator

Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Barbara McCracken-Bussa, Phone: 614-293-4254, Email: barbara.mccracken-bussa@osumc.edu
Peter Muscarella, MD, Principal Investigator

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Recruiting
Boo Bennett, Phone: 405-271-8920, Ext: option 1, Email: bronwyn-bennett@ouhsc.edu
Mehrdad Jafari, MD, Principal Investigator

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Becky Miller, Phone: 717-531-1003, Email: rmiller13@hmc.psu.edu
Yixing Jiang, MD, PHD, Principal Investigator

Cancer Centers of the Carolinas, Greenville, South Carolina 29615, United States; Recruiting
Julie Martin, Phone: 864-241-6251, Email: julie.martin@usoncology.com
Joe Stephenson, MD, Principal Investigator

Sri Ramchandra Medical College & Research Institute, Ponur, Chennai, Tamil Nadu 600116, India; Recruiting
Arcot Rekha, MD, Phone: 9841241344
Arcot Rekha, MD, Principal Investigator

PSG Hospitals, Peelamedu, Coimbatore, Tamil Nadu 641004, India; Recruiting
Akila Kunthu Balaraman, MD, Phone: 04222570170
Akila Kunthu Balaraman, MD, Principal Investigator

The Texas Cancer Center Dallas Southwest, Dallas, Texas 75237, United States; Recruiting
Carolyn Cox, Phone: 972-780-3406, Email: carolyn.cox@usoncology.com
John V Cox, MD, Principal Investigator

Tyler Cancer Center, Tyler, Texas 75702, United States; Recruiting
Linda Dunklin, Phone: 903-579-9800, Email: linda.dunklin@usoncology.com
Donald A Richards, MD, PHD, Principal Investigator

Texas Oncology, PA, Dallas, Texas 75231, United States; Recruiting
Kay Smith, RN, Phone: 214-364-3508, Email: kaylene.smith@usoncology.com
Maricela Herron, RN, Phone: 214-346-3508, Email: maricela.herron@usoncology.com
Kristi J McIntyre, MD, Principal Investigator

South Texas Oncology & Hematology, San Antonio, Texas 78229, United States; Recruiting
Jill Goulet, RN, CCRC, Phone: 210-593-2572, Email: Jill.Goulet@stoh.com
Lon S Smith, MD, Principal Investigator

Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Glenn Wilson, Phone: 713-798-3468, Email: ggwilson@bcm.edu
William E Fisher, MD, Principal Investigator

Fairfax Northern Virginia Hematology-Oncology, PC, Fairfax, Virginia 22031, United States; Active, not recruiting

Seattle Cancer Care Alliance, Seattle, Washington 98109, United States; Recruiting
Jennifer Revall, CCRC, Phone: 206-667-2989, Email: jlrevall@fhcrc.org
Sam Whiting, MD, Principal Investigator

Northwest Cancer Specialists, PC, Vancouver, Washington 98684, United States; Recruiting
Michelle Jones, Phone: 503-525-8642, Email: michelle.jones@usoncology.com
David A Smith, MD, Principal Investigator

Froedtert Multi-Disciplinary Cancer Clinic, Milwaukee, Wisconsin 53226, United States; Recruiting
Christy Truelove, Phone: 414-805-6590, Email: ctruelov@mcw.edu
Paul S Ritch, MD, Principal Investigator

Sponsor website

Starting date: January 2006
Last updated: February 4, 2009