Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

December 1, 2019 updated by: Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220000
        • Minsk City Clinical Oncologic Dispensary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 9, 2017

Primary Completion (ACTUAL)

May 3, 2019

Study Completion (ACTUAL)

May 23, 2019

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (ACTUAL)

April 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2019

Last Update Submitted That Met QC Criteria

December 1, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRPCEM_DC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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