Low Dose Vaccine Study for Surgically Resected Pancreatic Cancer

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Brief Title

Low Dose Vaccine Study for Surgically Resected Pancreatic Cancer

Official Title

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 We will use overall survival and adverse events rates as secondary endpoints.

Condition

Pancreatic Cancer

Intervention

HyperAcute(R)-Pancreatic Cancer Vaccine

Study Arms / Comparison Groups

 1
Description:  Vaccine + chemo + chemoradiation therapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

9

Start Date

January 2008

Completion Date

December 2014

Primary Completion Date

May 2010

Eligibility Criteria

        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).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Charles J. Link, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00614601

Organization ID

NLG0305

Secondary IDs

OBA#0704-844

Responsible Party

Sponsor

Study Sponsor

NewLink Genetics Corporation


Study Sponsor

Charles J. Link, M.D., Study Chair, NewLink Genetics Corporation


Verification Date

May 2015