Clinical Trials /

DC Vaccine in Colorectal Cancer

NCT03730948

Description:

This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: DC Vaccine in Colorectal Cancer
  • Official Title: Pilot Study of Mature Dendritic Cell Vaccination for Resected Hypermutated Colorectal Cancer

Clinical Trial IDs

  • ORG STUDY ID: UPCC 16218, 831453
  • NCT ID: NCT03730948

Conditions

  • Colorectal Cancer

Interventions

DrugSynonymsArms
DC vaccineAll subjects

Purpose

This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.

Detailed Description

      This is a pilot study to assess the safety and tolerability, as well as the immune response
      rate, of mDC3 vaccine in patients with colorectal cancer.

      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 mutated peptides. 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
All subjectsExperimentalAll subjects will receive the vaccine and be followed per the schedule of procedures.
  • DC vaccine

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologically-confirmed stage I and II hypermutated colorectal cancer (CRC)

          -  Surgically resected disease

          -  Male or female patients 18+ years of age

          -  ECOG performance status 0-1

          -  Certain 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 malignancy within 3 years that may put subject at risk

          -  Pregnant or nursing women

          -  Concurrent treatment with systemic immunosuppressants including corticosteroids,
             calcineurin inhibitors, antiproliferative agents within 2 weeks of consent. Local
             (inhaled or topical) steroids or replacement dose prednisone are permitted.

          -  Known allergy to eggs

          -  Any uncontrolled intercurrent illness or active ongoing infection thta may put subject
             at additional risk
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Changes in numbers of peptide-specific CD8+ T cells (post-vaccine immune response)
Time Frame:Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.
Safety Issue:
Description:Numbers of peptide-specific CD8+ T cells will be measured by flow cytometric-based intracellular cytokine or tetramer staining

Secondary Outcome Measures

Measure:Percentage of CD8+ cells in primary tumor tissue
Time Frame:Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.
Safety Issue:
Description:Descriptive models

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Pennsylvania

Trial Keywords

  • colorectal cancer
  • cancer vaccine
  • dendritic cell vaccine

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