Immunotherapy Study for Surgically Resected Pancreatic Cancer
A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without Algenpantucel-L (HyperAcute®-Pancreas) Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer
2 other identifiers
interventional
722
1 country
75
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pancreatic-cancer
Started Apr 2010
Typical duration for phase_3 pancreatic-cancer
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2010
CompletedFirst Posted
Study publicly available on registry
February 22, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 28, 2020
May 1, 2020
6.1 years
February 18, 2010
May 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective is to assess overall survival
Approximately 41 months and 48 months
Secondary Outcomes (1)
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.
Approximately 41 months and 48 months
Study Arms (2)
HyperAcute-Pancreas Immunotherapy + Standard of Care
EXPERIMENTAL\*Adjuvant Standard of Care Treatment (SOC) consisting of gemcitabine with or without 5FU chemoradiation + HyperAcute Immunotherapy
Standard of Care alone
ACTIVE COMPARATOR\*Adjuvant Standard of Care Treatment (SOC) consisting of gemcitabine with or without 5FU chemoradiation Alone
Interventions
Up to 18 immunizations of 300 million immunotherapy cells
Gemcitabine 1000 mg/m2/day once a week for 3 weeks
5FU 200-250 mg/m2/day over 5 1/2 weeks with radiation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (75)
University of Alabama
Birmingham, Alabama, 35249, United States
University of South Alabama
Mobile, Alabama, 36604, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
University of Southern California
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Stanford Cancer Center
Palo Alto, California, 94304, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of Colorado
Aurora, Colorado, 80045, United States
Stamford Hospital
Stamford, Connecticut, 06902, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
Boca Raton Hospital
Boca Raton, Florida, 33486, United States
University of Florida
Gainesville, Florida, 32610, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
University of Miami
Miami, Florida, 33136, United States
USF Tampa General
Tampa, Florida, 33606, United States
MOFFITT
Tampa, Florida, 33612, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Northwestern University
Chicago, Illinois, 60611, United States
Northshore University Health Systems
Evanston, Illinois, 60201, United States
Edward H. Kaplan, MD and Associates
Skokie, Illinois, 60076, United States
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46260, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Ochsner Cancer Institute
New Orleans, Louisiana, 70121, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55409, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Missouri
Columbia, Missouri, 65203, United States
Washington University
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University of New Mexico
Albuquerque, New Mexico, 87106, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest Baptist Health Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University Hospitals Case Western
Cleveland, Ohio, 44106, United States
Ohio State University
Columbus, Ohio, 43221, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Roger Williams Medical Center
Providence, Rhode Island, 02908, United States
Greenville Health System
Greenville, South Carolina, 29615, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Ben Taub Hospital
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
University of Texas Health Sciences
San Antonio, Texas, 78229, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Lynchburg Hematology-Oncology Clinic, Inc.
Lynchburg, Virginia, 24501, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
University of Washington- Seattle Cancer Center Alliance
Seattle, Washington, 98109, United States
Vince Lombardi Cancer Clinic
Green Bay, Wisconsin, 54311, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Related Publications (1)
Hardacre JM, Mulcahy M, Small W, Talamonti M, Obel J, Krishnamurthi S, Rocha-Lima CS, Safran H, Lenz HJ, Chiorean EG. Addition of algenpantucel-L immunotherapy to standard adjuvant therapy for pancreatic cancer: a phase 2 study. J Gastrointest Surg. 2013 Jan;17(1):94-100; discussion p. 100-1. doi: 10.1007/s11605-012-2064-6. Epub 2012 Nov 15.
PMID: 23229886DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2010
First Posted
February 22, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 28, 2020
Record last verified: 2020-05