Know Cancer

or
forgot password

A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without HyperAcute®-Pancreas (Algenpantucel-L) Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective is to assess overall survival

Outcome Time Frame:

Approximately 41 months and 48 months

Safety Issue:

No

Principal Investigator

Nicholas N Vahanian, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

NewLink Genetics Corporation

Authority:

United States: Food and Drug Administration

Study ID:

NLG0405

NCT ID:

NCT01072981

Start Date:

April 2010

Completion Date:

January 2014

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Vaccine Therapy
  • Pancreatic Neoplasms

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