Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

Overview

The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed dendritic cell Immunotherapy for the patients with pancreatic cancer

Full Title of Study: “Single-center Trial Evaluating the Safety and Efficacy of MUC-1/WT-1 Peptide or Tumor Lysate-pulsed Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 3, 2019

Detailed Description

The trial evaluates the safety and efficacy of dendritic cell Immunotherapy for the patients with pancreatic cancer. Dendritic cells are obtained from blood monocytes using standard protocol.

Two options for dendritic cell priming are used: MUC-1/WT-1 peptides for the patients with unresectable tumor and/or tumor lysates for the patients undergoing tumor resection.

The dendritic cells are them matured and injected subcutaneous (all patients) and intratumorally (when possible).

Interventions

  • Biological: Dendritic cells pulsed with tumor lysate
  • Biological: Dendritic cells pulsed with MUC-1/WT-1 peptides

Arms, Groups and Cohorts

  • Experimental: Dendritic cells lysate-pulsed group
    • Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate
  • No Intervention: Control group
    • Patients treated according to clinical protocols
  • Experimental: Dendritic cells peptide-pulsed group
    • Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with MUC-1/WT-1 peptides

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants with PR or CR at 1 year
    • Time Frame: 1 year
    • 1 year PR/CR
  • Number of Participants Who Survived at 1 Year
    • Time Frame: 1 year
    • 1 year overall survival

Secondary Measures

  • Antigen-specific immune response
    • Time Frame: 1 year
    • The increase of antigen-specific T-cells
  • Circulating tumor cells count
    • Time Frame: 1 year
    • Decrease of EpCAM+CD45- circulating tumor cells count
  • Immune response
    • Time Frame: 1 year
    • Decrease of T-regulatory cells
  • Number of Participants Who Survived at 2 Years
    • Time Frame: 2 years
    • 2 year overall survival
  • Number of Participants Who Survived at 3 Years or more
    • Time Frame: 3 years
    • 3 year overall survival

Participating in This Clinical Trial

Inclusion Criteria

  • histologically or cytologically confirmed pancreatic cancer (adenocarcinoma);
  • HLA-A2 expression by tumor cells;
  • WT-1/MUC-1 expression by tumor cells.

Exclusion Criteria

  • refuse of patient to participate in the trial;
  • pregnancy/lactation;
  • intercurrent severe chronic diseases;
  • HIV, Hepatites B/C;
  • active tuberculosis;
  • alcohol use disorder/drug addiction.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Republican Research and Practical Center for Epidemiology and Microbiology
  • Collaborator
    • Belarusian State Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrei Y. Hancharou, Head of the Laboratory for Immunology and Cellular Biotechnology – The Republican Research and Practical Center for Epidemiology and Microbiology
  • Overall Official(s)
    • Alexander V. Prokharau, Prof., Study Director, Belarussian State Medical University, Minsk, Belarus
    • Andrei Y Hancharou, Dr., Study Director, The Republican Research and Practical Center for Epidemiology and Microbiology

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