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Low Dose Vaccine Study for Surgically Resected Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00614601
Recruitment Status : Terminated (Sponsor proceeded with a phase III study for same indication.)
First Posted : February 13, 2008
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
NewLink Genetics Corporation

Tracking Information
First Submitted Date  ICMJE January 31, 2008
First Posted Date  ICMJE February 13, 2008
Last Update Posted Date June 26, 2015
Study Start Date  ICMJE January 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
We will use overall survival and adverse events rates as secondary endpoints. [ Time Frame: Duration of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2008)
We will use tumor response rate, overall survival and adverse events rates as secondary endpoints. [ Time Frame: Duration of study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Vaccine Study for Surgically Resected Pancreatic Cancer
Official Title  ICMJE A Phase II Study of Low Dose Algenpantucel-L (HyperAcute Pancreas) Cancer Vaccine in Subjects With Surgically Resected Pancreatic Cancer
Brief Summary To assess the response for subjects with pancreatic cancer that have undergone surgical resection and treatment with a vaccine given with or without chemotherapy and chemoradiation.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: 1
    Vaccine + chemo + chemoradiation therapy
    Intervention: Biological: HyperAcute(R)-Pancreatic Cancer Vaccine
  • Experimental: 2
    Vaccine Only
    Intervention: Biological: HyperAcute(R)-Pancreatic Cancer Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 20, 2013)
9
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2008)
82
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A histological diagnosis of adenocarcinoma of the pancreas. The patient's pathology must be reviewed and confirmed by the clinical site's Pathology Department.
  • 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 or 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00614601
Other Study ID Numbers  ICMJE NLG0305
OBA#0704-844
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NewLink Genetics Corporation
Study Sponsor  ICMJE NewLink Genetics Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Charles J. Link, M.D. NewLink Genetics Corporation
PRS Account NewLink Genetics Corporation
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP