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Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03114631
First Posted: April 14, 2017
Last Update Posted: April 17, 2017
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.
Collaborator:
Belarusian state medical university
Information provided by (Responsible Party):
Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology
  Purpose
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

Condition Intervention Phase
Dendritic Cells Pancreatic Neoplasms Biological: Dendritic cells pulsed with tumor lysate Biological: Dendritic cells pulsed with MUC-1/WT-1 peptides Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome 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 ]
  • Number of Participants Who Survived at 3 Years or more [ Time Frame: 3 years ]

Estimated Enrollment: 30
Actual Study Start Date: January 9, 2017
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dendritic cells lysate-pulsed group
Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate
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
Biological: Dendritic cells pulsed with MUC-1/WT-1 peptides

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114631


Locations
Belarus
Minsk City Clinical Oncologic Dispensary
Minsk, Belarus, 220000
Sponsors and Collaborators
The Republican Research and Practical Center for Epidemiology and Microbiology
Belarusian state medical university
Investigators
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, Minsk, Belarus
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
In Russian
Study Protocol  This link exits the ClinicalTrials.gov site
In Russian

Responsible Party: Andrei Y. Hancharou, Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
ClinicalTrials.gov Identifier: NCT03114631     History of Changes
Other Study ID Numbers: RRPCEM_DC1
First Submitted: April 11, 2017
First Posted: April 14, 2017
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology:
dendritic cells, pancreatic cancer, immunotherapy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases