Clinical Trials /

DC Vaccine in Pancreatic Cancer

NCT03592888

Description:

This research study is designed to evaluate the effects of a dendritic cell (kind of white blood cell) vaccine for pancreatic cancer.

Related Conditions:
  • Pancreatic Ductal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: DC Vaccine in Pancreatic Cancer
  • Official Title: Pilot Study of Mature Dendritic Cell Vaccination Against Mutated KRAS in Patients With Resectable Pancreatic Cancer

Clinical Trial IDs

  • ORG STUDY ID: UPCC 04218
  • NCT ID: NCT03592888

Conditions

  • Pancreatic Ductal Adenocarcinoma

Interventions

DrugSynonymsArms
mDC3/8-KRAS Vaccine

Purpose

This research study is designed to evaluate the effects of a dendritic cell (kind of white blood cell) vaccine for pancreatic cancer.

Detailed Description

      This is a single arm open label trial that will assess the safety and tolerability of mature
      dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic
      adenocarcinoma.

      Eligible patients that provide written informed consent will undergo apheresis to collect
      blood mononuclear cells for vaccine production approximately 1 week prior to vaccine
      infusion. Each study subject will receive cyclophosphamide 300mg/m^2 intravenously 3 to 4
      days prior to the vaccine dose to deplete regulatory T cells. For each vaccine dose, all
      subjects will receive autologous dendritic cells pulsed with mutant KRAS peptides
      corresponding to the subject's specific tumor mutation and human leukocyte antigen type. On
      Day 1, the subject will receive the primer vaccine dose; this will be followed by one booster
      vaccine dose approximately 8 weeks later. Peripheral blood will be taken weekly, and a second
      apheresis procedure will be performed at the end of study to monitor the immune response to
      the vaccine. Information will be gathered from usual clinic visits for approximately 1 year
      following the End of Treatment Study Visit to evaluate for disease progression.
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologically-confirmed KRAS(G12D-), KRAS(G12V-), KRAS(G12R-) or KRAS(G12C-mutated)
             pancreatic ductal adenocarcinoma who are at high risk of relapse and have no evidence
             of disease.

          -  Expression of one or more of the following HLA class I alleles: HLA-A02, HLA-A03,
             HLA-A11, HLA-B07 and HLA-C08.

          -  Male or female, age 18+

          -  ECOG performance status 0-1

          -  Certain required laboratory values, performed within 14 days prior to consent

          -  Subjects of reproductive potential must agree to use a medically accepted birth
             control method during the trial and for at least two months following the trial.

          -  Provide written informed consent

        Exclusion Criteria:

          -  Prior treatment with more than one line of cytotoxic chemotherapy. Radiotherapy is not
             considered a line of therapy.

          -  Prior malignancy (except non-melanoma skin cancer) within 3 years.

          -  Pregnant or nursing women.

          -  Concurrent treatment with systemic immunosuppressants, including corticosteroids (e.g
             prednisone), calcineurin inhibitors (e.g tacrolimus, cyclosporine), antiproliferative
             agents (e.g mycophenolate mofetil, azathioprine) within 2 weeks of eligibility
             confirmation. Local (inhaled or topical) steroids or replacement dose prednisone (≤ 10
             mg daily) are permitted.

          -  Known chronic viral infections including hepatitis B, hepatitis C, and HIV.

          -  Known allergy to eggs.

          -  Prior history of uveitis or autoimmune inflammatory eye disease.

          -  Uncontrolled intercurrent illness.

          -  Any condition that, in the opinion of the investigator, would interfere with
             evaluation of the investigational product or interpretation of subject safety or study
             results.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and side effects of vaccine per CTCAE 4.0
Time Frame:At time of consent through 30 days after the subject's last DC vaccine
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Immune response measuring increased numbers of peptide specific T cells as calculated by the peptide-MHC multimer assay.
Time Frame:Day 1 through week 12
Safety Issue:
Description:
Measure:Disease Free Survival
Time Frame:30 days following second vaccine through study completion approximately 12 months after the first DC vaccine
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Pennsylvania

Trial Keywords

  • Pancreatic Adenocarcinoma
  • Cancer vaccine
  • Dendritic cell vaccine
  • Mutant KRAS

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