Immunotherapy Study for Surgically Resected Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NewLink Genetics Corporation
ClinicalTrials.gov Identifier:
NCT01072981
First received: February 18, 2010
Last updated: April 2, 2014
Last verified: April 2014
  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:


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 2015
Estimated Primary Completion Date: January 2015 (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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072981

  Hide Study Locations
Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249
University of South Alabama
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
University of Southern California
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Stanford Cancer Center
Palo Alto, California, United States, 94304
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Stamford Hospital
Stamford, Connecticut, United States, 06902
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
Boca Raton Hospital
Boca Raton, Florida, United States, 33486
University of Florida
Gainesville, Florida, United States, 32610
Mayo Clinic
Jacksonville, Florida, United States, 32224
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
University of Miami
Miami, Florida, United States, 33136
MOFFITT
Tampa, Florida, United States, 33612
USF Tampa General
Tampa, Florida, United States, 33606
United States, Illinois
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Northwestern University
Chicago, Illinois, United States, 60611
Northshore University Health Systems
Evanston, Illinois, United States, 60201
Edward H. Kaplan, MD and Associates
Skokie, Illinois, United States, 60076
United States, Indiana
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, United States, 46260
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Ochsner Cancer Institute
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55409
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65203
Washington University
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Columbia University
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest Baptist Health Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
University Hospitals Case Western
Cleveland, Ohio, United States, 44106
Ohio State University
Columbus, Ohio, United States, 43221
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, United States, 18015
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburg Medical Center
Pittsburg, Pennsylvania, United States, 15232
United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29615
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
Ben Taub Hospital
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
University of Texas Health Sciences
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Lynchburg Hematology-Oncology Clinic, Inc.
Lynchburg, Virginia, United States, 24501
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington- Seattle Cancer Center Alliance
Seattle, Washington, United States, 98109
United States, Wisconsin
Vince Lombardi Cancer Clinic
Green Bay, Wisconsin, United States, 54311
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
NewLink Genetics Corporation
Investigators
Study Director: Nicholas N Vahanian, M.D. NewLink Genetics Corporation
  More Information

Additional Information:
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 2, 2014
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 July 09, 2014