A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without HyperAcute®-Pancreas (Algenpantucel-L) Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer
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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective is to assess overall survival
Approximately 41 months and 48 months
No
Nicholas N Vahanian, M.D.
Study Director
NewLink Genetics Corporation
United States: Food and Drug Administration
NLG0405
NCT01072981
April 2010
January 2014
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
University of Iowa | Iowa City, Iowa 52242 |
University of Alabama | Birmingham, Alabama |
Arizona Cancer Center | Tucson, Arizona 85724 |
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Mayo Clinic | Rochester, Minnesota 55905 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Missouri | Columbia, Missouri 65212 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Roger Williams Medical Center | Providence, Rhode Island 02908-4735 |
Mount Sinai Medical Center | New York, New York 10029 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Mayo Clinic | Jacksonville, Florida 32224 |
University of Colorado | Denver, Colorado 80217 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of Oklahoma | Oklahoma City, Oklahoma 73190 |
Stanford Cancer Center | Stanford, California 94305-5824 |
Ochsner Cancer Institute | New Orleans, Louisiana 70121 |
University of Virginia | Charlottesville, Virginia 22908 |
Columbia University | New York, New York 10032-3784 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Duke University Medical Center | Durham, North Carolina 27710 |
Georgetown University | Washington, District of Columbia 20007-2197 |
Northwestern University | Chicago, Illinois 60611 |
University of Florida | Gainesville, Florida 32610-0277 |
Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
Ohio State University | Columbus, Ohio 43210 |
California Pacific Medical Center | San Francisco, California 94115 |
University of Louisville | Louisville, Kentucky 40202 |
University of Maryland | Baltimore, Maryland 21201 |
Lahey Clinic | Burlington, Massachusetts 01805 |
Washington University | St. Louis, Missouri 63110 |
University of Texas Southwestern Medical Center | Dallas, Texas |
St. Luke's Hospital and Health Network | Bethlehem, Pennsylvania 18015 |
University of New Mexico | Albuquerque, New Mexico 87131 |
Sutter Institute for Medical Research | Sacramento, California 95816 |
University of Miami | Miami, Florida 33136 |
The Methodist Hospital | Houston, Texas 77030 |
Oregon Health and Science University | Portland, Oregon 97201 |
Virginia Commonwealth University | Richmond, Virginia |
Indiana University | Indianapolis, Indiana 46202 |
University of Southern California | Los Angeles, California 90033 |
University of Wisconsin | Madison,, Wisconsin 53792-5666 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
University of Kansas Cancer Center | Kansas City, Kansas 66160 |
Stamford Hospital | Stamford, Connecticut 06904 |
University of South Alabama | Mobile, Alabama 36693 |
Investigative Clinical Research of Indiana, LLC | Indianapolis, Indiana 46254 |
Vince Lombardi Cancer Clinic | Two Rivers, Wisconsin 54241 |
University of Pittsburg Medical Center | Pittsburg, Pennsylvania 15213 |
Ben Taub Hospital | Houston, Texas 77030 |
University Hospitals Case Western | Cleveland, Ohio 44106 |
Penn State Hershey Cancer Institute | Hershey, Pennsylvania 17033 |
Beaumont Hospital | Royal Oak, Michigan 48073 |
Lynchburg Hematology-Oncology Clinic, Inc. | Lynchburg, Virginia |
Illinois Cancer Specialists | Niles, Illinois 60714 |
Boca Raton Hospital | Boca Raton, Florida 33486 |
MOFFITT | Tampa, Florida 33612 |
USF Tampa General | Tampa, Florida 33606 |
Northshore University Health Systems | Evanston, Illinois 60201 |
Wake Forest Baptist Health Comprehensive Cancer Center | Winston-Salem, North Carolina 27157 |
University of Texas Health Sciences | San Antonio, Texas 78229 |
University of Washington- Seattle Cancer Center Alliance | Seattle, Washington 98109 |
Edward H. Kaplan, MD and Associates | Skokie, Illinois 60076 |
Greenville Health System | Greenville, South Carolina 29615 |