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Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

Primary Purpose

Dendritic Cells, Pancreatic Neoplasms

Status
Completed
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
Dendritic cells pulsed with tumor lysate
Dendritic cells pulsed with MUC-1/WT-1 peptides
Sponsored by
The Republican Research and Practical Center for Epidemiology and Microbiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dendritic Cells focused on measuring dendritic cells, pancreatic cancer, immunotherapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Minsk City Clinical Oncologic Dispensary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Dendritic cells lysate-pulsed group

Control group

Dendritic cells peptide-pulsed group

Arm Description

Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate

Patients treated according to clinical protocols

Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with MUC-1/WT-1 peptides

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 11, 2017
Last Updated
December 1, 2019
Sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology
Collaborators
Belarusian State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03114631
Brief Title
Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 9, 2017 (Actual)
Primary Completion Date
May 3, 2019 (Actual)
Study Completion Date
May 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology
Collaborators
Belarusian State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dendritic Cells, Pancreatic Neoplasms
Keywords
dendritic cells, pancreatic cancer, immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dendritic cells lysate-pulsed group
Arm Type
Experimental
Arm Description
Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients treated according to clinical protocols
Arm Title
Dendritic cells peptide-pulsed group
Arm Type
Experimental
Arm Description
Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with MUC-1/WT-1 peptides
Intervention Type
Biological
Intervention Name(s)
Dendritic cells pulsed with tumor lysate
Intervention Type
Biological
Intervention Name(s)
Dendritic cells pulsed with MUC-1/WT-1 peptides
Primary Outcome Measure Information:
Title
Number of Participants with PR or CR at 1 year
Description
1 year PR/CR
Time Frame
1 year
Title
Number of Participants Who Survived at 1 Year
Description
1 year overall survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Antigen-specific immune response
Description
The increase of antigen-specific T-cells
Time Frame
1 year
Title
Circulating tumor cells count
Description
Decrease of EpCAM+CD45- circulating tumor cells count
Time Frame
1 year
Title
Immune response
Description
Decrease of T-regulatory cells
Time Frame
1 year
Title
Number of Participants Who Survived at 2 Years
Description
2 year overall survival
Time Frame
2 years
Title
Number of Participants Who Survived at 3 Years or more
Description
3 year overall survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander V. Prokharau, Prof.
Organizational Affiliation
Belarussian State Medical University, Minsk, Belarus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrei Y Hancharou, Dr.
Organizational Affiliation
The Republican Research and Practical Center for Epidemiology and Microbiology
Official's Role
Study Director
Facility Information:
Facility Name
Minsk City Clinical Oncologic Dispensary
City
Minsk
ZIP/Postal Code
220000
Country
Belarus

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

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