Vaccine 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:
NCT00569387
First received: December 5, 2007
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

To assess the response for subjects with pancreatic cancer that have undergone surgical resection and treatment with a vaccine given with chemotherapy and chemoradiation.


Condition Intervention Phase
Pancreatic Cancer
Biological: HyperAcute(R)-Pancreatic Cancer Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of HyperAcute(R)-Pancreatic Cancer Vaccine 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 of this Phase II trial is to assess disease-free survival (DFS) at one (1) year following initiation of treatment as the primary endpoint of the study in subjects treated with the HyperAcute®-Pancreatic Cancer Vaccine [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • We will use overall survival and adverse events rates as secondary endpoints. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 71
Study Start Date: December 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine group Biological: HyperAcute(R)-Pancreatic Cancer Vaccine
100 million vaccine cells will be injected intradermally for up to 14 vaccinations over approximately 8 months
Other Name: HAPa-1 and HAPa-2 vaccine components

Detailed Description:

Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most patients diagnosed with pancreatic cancer continue to die from their disease in a very short period of time. The primary reason for this is the short progression time of the disease; in fact, most patients with pancreatic cancer have symptoms at the time of the diagnosis. Moreover, lack of any single agent or procedure to have any significant impact on long term survival rates further contributes to poor prognostic outcomes observed with this disease.

These reasons are the major causes of cancer progression that are usually discussed when considering treatment options for patients with disease that continues to grow and spread. However, another important part of the body should be considered-- the immune system. Scientists have clearly shown that pancreatic cancer cells as well as other cancer cells produce a number of abnormal proteins or abnormal amounts of certain proteins not found in normal cells. Normally one would expect a patient to develop an immune response against these abnormal proteins found in their cancer and attack them much the way we would fight off an infection from a foreign bacteria or virus. However, for reasons that scientists do not fully understand, the immune system fails to respond to these abnormal proteins and does not attack the cancer cells. This human clinical trial proposes a new way to make the immune system recognize the cancer and encourage it to attack the cancer cells.

Many people are familiar with the idea of transplants between people of organs like the kidneys or heart. When an organ transplant between two people is completed one of the problems that can occur is rejection of the donated organ by the recipient. This can occur because the immune system of the patient who receives the organ attacks the donated organ. If you were to attempt to transplant a pig heart to a human the rejection would be dramatically stronger than when organs are transplanted between two people. This is partly because lower animals express sugar-protein patterns on the surface of their cells that humans do not. In fact, our immune systems can quickly recognize tissues from lower mammals such as the pig or the mouse and destroys them.

In this project, we propose to put a mouse gene into human pancreatic cancer cells that produces these abnormal sugar patterns and stimulates the immune system to attack the pancreatic cancer. This strategy works well to kill other human cancer cells in the laboratory, but it needs to be tried in pancreatic cancer patients to see if it will be effective. We propose to test this new treatment in patients with pancreatic cancer who have undergone tumor resection to see if it can stop or slow recurrence of tumors in these patients. Patients will be injected with an anti-tumor vaccine consisting of a mixture of two types of dead human pancreatic cancer cells that have been genetically altered to express the mouse gene responsible for making this abnormal sugar-protein on the cells.

  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.
  • AJCC Stage I or II Pancreatic carcinoma (See Appendix A). 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 have a negative serology for HIV prior to entering study.
  • Subjects must be able to take in ≥ 1500 calories daily.
  • Adequate organ function including:
  • Marrow: WBC ≥3000/mm3 and platelets ≥100,000/mm3.
  • Hepatic: serum total bilirubin ≤ 2 x ULN mg/dL, ALT (SGPT) and AST (SGOT) ≤3 x upper limit of normal (ULN).
  • Renal: serum creatinine (sCr) ≤2.0 x ULN, or creatinine clearance (Ccr) ≥30 mL/min.
  • First vaccination must be within 6 weeks after surgery.
  • Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able give written informed consent to participate.
  • 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.
  • Other malignancy within five years, unless the probability of recurrence of the prior malignancy is <5%. 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 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 1-week 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 vaccine or cell lines.
  • 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 7 days of first vaccination).
  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: NCT00569387

Locations
United States, Arizona
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
University of Southern California
Los Angeles, California, United States, 90033
University of California - Irvine
Orange, California, United States, 92868
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Ohio
University Hospitals Case Western
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
NewLink Genetics Corporation
Investigators
Study Chair: Charles J. Link, M.D. NewLink Genetics Corporation
  More Information

No publications provided

Responsible Party: NewLink Genetics Corporation
ClinicalTrials.gov Identifier: NCT00569387     History of Changes
Other Study ID Numbers: NLG0205, OBA#0701-829
Study First Received: December 5, 2007
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NewLink Genetics Corporation:
pancreatic cancer
vaccine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 29, 2014