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Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114631
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
Belarusian State Medical University
Information provided by (Responsible Party):
Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology

Tracking Information
First Submitted Date  ICMJE April 11, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date December 3, 2019
Actual Study Start Date  ICMJE January 9, 2017
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
  • Number of Participants with PR or CR at 1 year [ Time Frame: 1 year ]
  • Number of Participants Who Survived at 1 Year [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
  • Immunologic Response [ Time Frame: 1 year ]
    The increase of antigen-specific T-cells, decrease of T-regulatory cells and other cell subsets, associated with tumor progression (exhausted T-cells, myeloid-derived suppressor cells etc.)
  • Circulating tumor cells count [ Time Frame: 1 year ]
    Decrease of EpCAM+CD45- circulating tumor cells count
  • Number of Participants Who Survived at 2 Years [ Time Frame: 2 years ]
  • Number of Participants Who Survived at 3 Years or more [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer
Official Title  ICMJE 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
Brief Summary 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dendritic Cells
  • Pancreatic Neoplasms
Intervention  ICMJE
  • Biological: Dendritic cells pulsed with tumor lysate
  • Biological: Dendritic cells pulsed with MUC-1/WT-1 peptides
Study Arms  ICMJE
  • Experimental: Dendritic cells lysate-pulsed group
    Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate
    Intervention: Biological: 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
    Intervention: Biological: Dendritic cells pulsed with MUC-1/WT-1 peptides
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 23, 2019
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03114631
Other Study ID Numbers  ICMJE RRPCEM_DC1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology
Study Sponsor  ICMJE The Republican Research and Practical Center for Epidemiology and Microbiology
Collaborators  ICMJE Belarusian State Medical University
Investigators  ICMJE
Study Director: Alexander V. Prokharau, Prof. Belarussian State Medical University, Minsk, Belarus
Study Director: Andrei Y Hancharou, Dr. The Republican Research and Practical Center for Epidemiology and Microbiology
PRS Account The Republican Research and Practical Center for Epidemiology and Microbiology
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP