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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 MedicineHouston, Texas  77030
University of IowaIowa City, Iowa  52242
University of AlabamaBirmingham, Alabama  
Arizona Cancer CenterTucson, Arizona  85724
University of MichiganAnn Arbor, Michigan  48109-0624
Mayo ClinicRochester, Minnesota  55905
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Henry Ford HospitalDetroit, Michigan  48202
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cedars-Sinai Medical CenterLos Angeles, California  90048
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of MissouriColumbia, Missouri  65212
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Roger Williams Medical CenterProvidence, Rhode Island  02908-4735
Mount Sinai Medical CenterNew York, New York  10029
City of Hope National Medical CenterLos Angeles, California  91010
Mayo ClinicJacksonville, Florida  32224
University of ColoradoDenver, Colorado  80217
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of OklahomaOklahoma City, Oklahoma  73190
Stanford Cancer CenterStanford, California  94305-5824
Ochsner Cancer InstituteNew Orleans, Louisiana  70121
University of VirginiaCharlottesville, Virginia  22908
Columbia UniversityNew York, New York  10032-3784
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Duke University Medical CenterDurham, North Carolina  27710
Georgetown UniversityWashington, District of Columbia  20007-2197
Northwestern UniversityChicago, Illinois  60611
University of FloridaGainesville, Florida  32610-0277
Lakeland Regional Cancer CenterLakeland, Florida  33805
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Ohio State UniversityColumbus, Ohio  43210
California Pacific Medical CenterSan Francisco, California  94115
University of LouisvilleLouisville, Kentucky  40202
University of MarylandBaltimore, Maryland  21201
Lahey ClinicBurlington, Massachusetts  01805
Washington UniversitySt. Louis, Missouri  63110
University of Texas Southwestern Medical CenterDallas, Texas  
St. Luke's Hospital and Health NetworkBethlehem, Pennsylvania  18015
University of New MexicoAlbuquerque, New Mexico  87131
Sutter Institute for Medical ResearchSacramento, California  95816
University of MiamiMiami, Florida  33136
The Methodist HospitalHouston, Texas  77030
Oregon Health and Science UniversityPortland, Oregon  97201
Virginia Commonwealth UniversityRichmond, Virginia  
Indiana UniversityIndianapolis, Indiana  46202
University of Southern CaliforniaLos Angeles, California  90033
University of WisconsinMadison,, Wisconsin  53792-5666
University of CincinnatiCincinnati, Ohio  45267-0502
University of Kansas Cancer CenterKansas City, Kansas  66160
Stamford HospitalStamford, Connecticut  06904
University of South AlabamaMobile, Alabama  36693
Investigative Clinical Research of Indiana, LLCIndianapolis, Indiana  46254
Vince Lombardi Cancer ClinicTwo Rivers, Wisconsin  54241
University of Pittsburg Medical CenterPittsburg, Pennsylvania  15213
Ben Taub HospitalHouston, Texas  77030
University Hospitals Case WesternCleveland, Ohio  44106
Penn State Hershey Cancer InstituteHershey, Pennsylvania  17033
Beaumont HospitalRoyal Oak, Michigan  48073
Lynchburg Hematology-Oncology Clinic, Inc.Lynchburg, Virginia  
Illinois Cancer SpecialistsNiles, Illinois  60714
Boca Raton HospitalBoca Raton, Florida  33486
MOFFITTTampa, Florida  33612
USF Tampa GeneralTampa, Florida  33606
Northshore University Health SystemsEvanston, Illinois  60201
Wake Forest Baptist Health Comprehensive Cancer CenterWinston-Salem, North Carolina  27157
University of Texas Health SciencesSan Antonio, Texas  78229
University of Washington- Seattle Cancer Center AllianceSeattle, Washington  98109
Edward H. Kaplan, MD and AssociatesSkokie, Illinois  60076
Greenville Health SystemGreenville, South Carolina  29615