Vaccine Treatment for Surgically Resected Pancreatic Cancer

Learn more about:
Related Clinical Trial
Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer Impact of Margin-accentuation IRE in Pancreatic Cancer Cetuximab, Gemcitabine, and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer Gemcitabine, Cisplatin, and Bevacizumab in Treating Patients With Metastatic Pancreatic Cancer Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer A Study Evaluating Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Cancer Capecitabine and Docetaxel in Treating Patients With Recurrent or Progressive Metastatic Pancreatic Cancer Gemcitabine, Bevacizumab, and Abdominal Radiation Therapy in Treating Patients With Localized Pancreatic Cancer Pemetrexed, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer Combination of Radiation Therapy and Anti-PD-1 Antibody in Treating Patients With Pancreatic Cancer IORT Followed by CCRT or SBRT for Locally Advanced Pancreatic Cancer Lapatinib Ditosylate and Capecitabine in Treating Patients With Metastatic Pancreatic Cancer Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer Diet and Exercise After Pancreatic Cancer Compassionate Single Subject Use of FG-3019 (FibroGen) in Locally Advanced, Unresectable Pancreatic Cancer Borderline Resectable Pancreatic Cancer: Gemcitabine/Docetaxel and Oxaliplatin Based Chemo/RT Induction Cetuximab (IM-C225), Gemcitabine, and Oxaliplatin in Pancreatic Cancer Patients Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Assessment of the Cytotoxic Immune Status of Pancreatic Cancer Patients and the Severity of the Cancer Using Measurement of Natural Killer Cell Activities Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer Panitumumab, Chemotherapy, and External-Beam Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot be Removed by Surgery Gem-TABS in Unresectable Pancreatic Carcinoma Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer Safety and Efficacy Study of Five-fraction Stereotactic Body Radiation Therapy to Locally Advanced Pancreatic Cancer Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer Laparoscopic Ultrasound in Diagnosing Patients With Pancreatic Cancer A Study of ABTL0812 in Pancreatic Cancer Immune Response After Pancreatic Cancer Treatment Combination of Stereotactic Body Radiation Therapy With S-1 for Treating Locally Advanced Pancreatic Cancer Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer A Safety Study Using Pentamidine in Patients With Pancreatic Cancer Undergoing Standard Therapy Radiofrequency Probe for Management of Unresectable Bile Duct and Pancreatic Cancer Bevacizumab and Erlotinib in Treating Patients With Metastatic Pancreatic Cancer That Did Not Respond to Previous Treatment With Gemcitabine Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Cancer Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer New Treatment Option for Pancreatic Cancer Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer Individual Patient Expanded Access IND of Hope Biosciences First Blood Relative Allogeneic Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) for Pancreatic Cancer Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer Radiation Therapy Plus Paclitaxel in Treating Patients With Nonmetastatic, Unresectable Pancreatic Cancer Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer Usefulness of Smartphone Application for Improving Nutritional Status of Pancreatic Cancer Patients Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer C-VISA BikDD: Liposome in Advanced Pancreatic Cancer Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Cancer QUILT-3.080: NANT Pancreatic Cancer Vaccine Bevacizumab, Combination Chemotherapy, and Radiation Therapy in Treating Patients Undergoing Surgery For Locally Advanced Pancreatic Cancer A Phase I/II Study of Lenalidomide in Combination With Gemcitabine in Patients With Untreated Advanced Carcinoma of the Pancreas Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer Oral Microbiome and Pancreatic Cancer IRESSA Combined With Radiotherapy & Gemcitabine as First-Line Treatment in Locally Advanced Pancreatic Cancer Impact of Three-dimensional Visualization on Operation Strategy and Complications for Pancreatic Cancer A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer Capecitabine as Second-Line Therapy in Treating Patients With Stage IV Pancreatic Cancer Who Have the Thymidylate Synthase Gene Collecting and Storing Samples of Blood From Patients With Pancreatic Cancer and Healthy Participants Genes as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer. BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer Neoadjuvant CCRT With Gemcitabine/Durvalumab (MEDI4736) Followed by Adjuvant Gemcitabine/Durvalumab(MEDI4736) in Resectable or Borderline Resectable Pancreatic Cancer A Real-world Study of Albumin-bound Paclitaxel in the Treatment of Pancreatic Cancer Gene Expression Profiles in Patients With Metastatic Pancreatic Cancer QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy Dasatinib in Treating Patients With Stage IV Pancreatic Cancer Study of Nivolumab, Cabiralizumab, and Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Unresectable Pancreatic Cancer Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy A Phase II Study of Combine Modality Therapy in Locally Advanced Pancreatic Cancer Endoscopic Ultrasound (EUS) Guided-Celiac Plexus Neurolysis (CPN) in Unresectable Pancreatic Cancer Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer Phase 2 Study of Erlotinib, Gemcitabine and Oxaliplatin Combination Chemotherapy to Advanced Pancreatic Cancer Ghrelin Levels in Pancreatic Cancer Patients Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP) Pilot Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer A Phase II Study of Locally Advanced Pancreatic Cancer QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy Phase III of Gemcitabine Vs TS-1 Vs Gemcitabine Plus TS-1 in Pancreatic Cancer Study of Ruxolitinib in Pancreatic Cancer Patients Gemcitabine/Cisplatin +/-Cetuximab in Patients With Locally Advanced or Metastatic EGFR-Positive Pancreatic Cancer Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer Oxaliplatin, Gemcitabine, and Erlotinib Study in Patients With Advanced Chemo-naïve Pancreatic Cancer QUILT-3.070:Pancreatic Cancer Vaccine: Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy Study of CellCept for Advanced Pancreatic Cancer Niraparib in Patients With Pancreatic Cancer Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer Longitudinal Pancreatic Cancer Study Safety and Efficiency of γδ T Cell Against Pancreatic Cancer A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer Autologous CARTmeso/19 Against Pancreatic Cancer Clinical Application of IRE Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oncologic Outcomes Based on Clinical Pattern of Preoperative PET-CT in Resected Pancreatic Cancer Depression, Cytokines and Pancreatic Cancer Relationship Between Vitamin D Biomarkers and Survival in Blood Samples From Patients With Advanced Pancreatic Cancer Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer A Dose Escalation Trial of SBRT After Induction Chemotherapy for Locally Advanced Pancreatic Cancer Left Celiac Plexus Resection for Pancreatic Cancer at the Body and Tail Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer Re-irradiation With Stereotactic Body Radiotherapy for Relapsed Pancreatic Cancer Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer Gemcitabine and S-1 for Locally Advanced Unresectable or Metastatic Pancreatic Cancer Mutation of K-RAS, CDKN2A, SMAD4 and TP53 in Pancreatic Cancer: Role of Liquid Biopsy in Preoperative Diagnosis Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer Identification of Biomarkers for Early Detection of Pancreatic Cancer Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer Nano Drug Interventional Therapy Using Digital Subtraction Angiography(DSA) for Pancreatic Carcinoma Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer Gene Expression in Pancreatic Cancer Optical and Biochemical Biomarkers in Early Pancreatic Cancer Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer Valproic Acid With Chemoradiotherapy for Pancreatic Cancer Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer Evaluation of Prognosis With Integrated MRI/PET in Patients With Pancreatic Cancer Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer A Trial of Chemo & Radiation Therapy for Pancreatic Cancer Phase I Study of Neoadjuvant Chemotherapy for Patients With Borderline Resectable Pancreatic Cancer. The Role of the Tumor Microenvironment of Pancreatic Cancer to Predict Treatment Outcome Ablation of Unresectable Locally Advanced Pancreatic Cancer With Irreversible Electroporation (IRE) System FOLFOX-A For Locally Advanced Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial Vaccine Treatment for Surgically Resected Pancreatic Cancer Characterizing the Pancreatic Cancer Proteome From Pancreatic Juice Quality of Life After Radiofrequency Ablation of Pancreatic Cancer Testing Spectrosense EVA System for Detection of Pancreatic Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy Safety and Feasibility of imILT Locally Advanced Pancreatic Cancer (LAPC) Vaccine Therapy in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery Pancreatic Cancer Collaborative Registry Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer Focused Ultrasound for the Treatment of Pancreatic Cancer – an International Registry Registry for Pancreatic Cancer Neoadjuvant/Adjuvant GVAX Pancreas Vaccine (With CY) With or Without Nivolumab and Urelumab Trial for Surgically Resectable Pancreatic Cancer Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer GI-4000 With Adoptive Transfer in Pancreatic Cancer Pancreatic Cancer Genetic Epidemiology (PACGENE) Study Electroporation (NanoKnife) as Treatment for Advanced Pancreatic Cancer Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer Clinical Trial of Pancreatic Cancer in Stockholm. Phase I/II Study of LDE225 With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer Acquisition of Portal Venous CTCs and Exosomes From Patients With Pancreatic Cancer by EUS Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas Stool Testing for Pancreatic Cancer A Phase III Study of Pancreatic Cancer Pancreatic Cancer Genetics Integrated Positron Emission Tomography – Computed Tomography (PET-CT) in Patients With Pancreatic Cancer RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer Circulating Cell-free Tumor DNA(ctDNA) in Pancreatic Cancer HepaSphere Interventional Therapy Using Digital Subtraction Angiography(DSA) for Pancreatic Cancer Vaccine Study for Surgically Resected Pancreatic Cancer Low Dose Vaccine Study for Surgically Resected Pancreatic Cancer Studying Biomarkers in Patients With Pancreatic Cancer Prospective Phase I Study of GAX for Metastatic Pancreatic Cancer Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery Biomarkers in Predicting Response to Treatment in Patients Who Have Undergone Surgery for Pancreatic Cancer Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

Brief Title

Vaccine Treatment for Surgically Resected Pancreatic Cancer

Official Title

A Phase I/II Study of Algenpantucel-L (HyperAcute Pancreas) an Antitumor Vaccination Using Alpha(1,3)Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Pancreatic Cancer

Brief Summary

      This 2-phase study will determine the safety of treating patients with pancreatic cancer with
      the genetically engineered HyperAcute-Pancreatic cancer vaccine. It will establish the proper
      vaccine dose and will examine side effects and potential benefits of the treatment. The
      vaccine contains killed pancreatic cancer cells containing a mouse gene that causes the
      production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the
      immune response to the foreign substance will stimulate the immune system to attack the
      patient's own cancer cells that have similar proteins without this sugar pattern, causing the
      tumor to remain stable or shrink.

      Patients 18 years of age or older with pancreatic cancer that has been surgically resected
      may be eligible for this study. Candidates will be screened with medical history and physical
      examination, blood tests, urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound
      scans may be obtained if needed.

      Participants will receive twelve vaccinations two weeks apart from each other. The vaccines
      will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase
      I of the study will treat successive groups of patients with increasing numbers of the
      vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase
      II will look for any beneficial effects of the vaccine given at the highest dose found to be
      safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine
      treatment. In addition, patient follow-up visits will be scheduled every 2 months for the
      remaining first year (6 months) after vaccination and then every 3 months for the next 2
      years for the following tests and procedures to evaluate treatment response and side effects:

      Medical history and physical examination Blood tests X-rays and various scans (nuclear
      medicine/CT/MRI) FACT-Hep Assessment questionnaire to measure the impact of treatment on the
      patient's general well-being. The questionnaire is administered before beginning treatment,
      monthly during treatment, and during follow-up visits after completing the treatment. It
      includes questions on the severity of pancreatic cancer symptoms and the ability to perform
      normal activities of daily life.
    

Detailed Description

      According to statistics of the American Cancer Society, an estimated 31,000 individuals will
      be diagnosed with pancreatic cancer and 25,000 will die of the disease, making it the fifth
      leading cause of U.S. cancer deaths this year despite all current therapy. This protocol
      attempts to exploit an approach to pancreatic cancer immunotherapy using a naturally
      occurring barrier to xenotransplantation in humans in an attempt to vaccinate patients
      against their pancreatic cancer. The expression of the murine alpha (1,3)
      galactosyltransferase [alpha (1,3) GT] gene results in the cell surface expression of alpha
      (1,3) galactosyl-epitopes (alpha-gal) on membrane glycoproteins and glycolipids. These
      epitopes are the major target of the hyperacute rejection response that occurs when organs
      are transplanted from non-primate donor species into man. Human hosts often have pre-existing
      anti-alpha-gal antibodies that bind alpha-gal epitopes and lead to rapid activation of
      complement and cell lysis. The pre-existing anti-alpha-gal antibodies found in most
      individuals are thought to be due to exposure to alpha-gal epitopes that are naturally
      expressed on normal gut flora leading to chronic immunological stimulation. These antibodies
      may comprise up to 1% of serum IgG. In this Phase I/II trial, patients with surgically
      resected pancreatic cancer will undergo a series of twelve intradermal injections with a
      vaccine composed of irradiated allogeneic pancreatic cancer cell lines (HAPa-1 and HAPa-2)
      that have been transduced with a recombinant Moloney murine leukemia virus (MoMLV)-based
      retroviral vector expressing the murine alpha (1,3) GT gene. Endpoints of the study include
      determination of dose-limiting toxicity (DLT), maximum tolerated dose (MTD), tumor and
      immunological responses.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

To assess the side effects, dose-limiting toxicity and maximum tolerated dose.

Secondary Outcome

 To assess the rate of recurrence after treatment.

Condition

Pancreatic Cancer

Intervention

HyperAcute-Pancreatic Cancer Vaccine


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

7

Start Date

November 2005

Completion Date

September 2007


Eligibility Criteria

        Inclusion Criteria:

          -  A histological diagnosis of adenocarcinoma or other exocrine carcinoma of the
             pancreas. The patient's pathology must be reviewed and confirmed by Northwestern
             University's Pathology Department.

          -  AJCC Stage I or II Pancreatic carcinoma. Patients must have undergone surgical
             resection for the tumor.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.

          -  Serum albumin greater than or equal to 2.5 gm/dL.

          -  Expected survival greater than or equal to 6 months.

          -  Subjects must have a negative serology for Hep B, C and HIV prior to entering study.

          -  All On-Study Tests must be less than or equal to Grade I toxicity for patient to be
             eligible for study, excluding serum LDH levels. PT, PTT must be less than or equal to
             1.5 x ULN except for patients who are on therapeutic anticoagulant therapy.

          -  Adequate organ function including:

        Marrow: hemoglobin greater than or equal to 10.0 gm/dL, absolute granulocyte count (AGC)
        greater than or equal to 1500/mm3, platelets greater than or equal to 100,000/mm3, absolute
        lymphocyte count greater than or equal to 475/mm3.

        Hepatic: serum total bilirubin less than or equal to 1.5 x ULN mg/dL, ALT (SGPT) and AST
        (SGOT) less than or equal to 2.5 x upper limit of normal (ULN).

        Renal: serum creatinine (sCr) less than or equal to 2.0 x ULN, or creatinine clearance
        (Ccr) greater than or equal to 30 mL/min.

          -  Prior therapy for pancreatic cancer that may include surgery and/or different
             neoadjuvant chemotherapy or adjuvant chemo-radiation regimens, or radiation therapy.
             Patients who undergo surgical resection and refuse chemotherapy or radiation therapy
             will be eligible.

          -  Patients must be greater than or equal to 4 weeks since surgery if treated with
             neoadjuvant therapy or greater than or equal to 4 weeks since conclusion of
             chemo-radiation if treated with post-operative adjuvant therapy and recovered from the
             toxicity of prior treatment to less than or equal to Grade I, exclusive of alopecia or
             fatigue.

          -  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. 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.

          -  Hypercalcemia > 2.9 mmol/L, unresponsive to standard therapy (e.g., I.V. hydration,
             diuretics, calcitonin or bisphosphonate therapy).

          -  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 or current active immunosuppressive therapy (such as
             cyclosporine, tacrolimus, etc.).

          -  Subjects taking systemic corticosteroid therapy for any reason are not eligible.
             Subjects receiving inhaled or topical corticosteroids are eligible. Subjects who
             require 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 alpha(1,3)galactosyltransferase tumor vaccine
             or cell lines.

          -  Prior splenectomy.

          -  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

Mary Mulcahy, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00255827

Organization ID

NLG0105



Study Sponsor

NewLink Genetics Corporation


Study Sponsor

Mary Mulcahy, M.D., Principal Investigator, Northwestern University


Verification Date

May 2015