Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

NCT ID: NCT03114631

Last Updated: 2019-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2019-05-23

Brief Summary

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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

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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).

Conditions

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Dendritic Cells Pancreatic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dendritic cells lysate-pulsed group

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

Group Type EXPERIMENTAL

Dendritic cells pulsed with tumor lysate

Intervention Type BIOLOGICAL

Control group

Patients treated according to clinical protocols

Group Type NO_INTERVENTION

No interventions assigned to this group

Dendritic cells peptide-pulsed group

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

Group Type EXPERIMENTAL

Dendritic cells pulsed with MUC-1/WT-1 peptides

Intervention Type BIOLOGICAL

Interventions

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Dendritic cells pulsed with tumor lysate

Intervention Type BIOLOGICAL

Dendritic cells pulsed with MUC-1/WT-1 peptides

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian State Medical University

OTHER

Sponsor Role collaborator

The Republican Research and Practical Center for Epidemiology and Microbiology

OTHER

Sponsor Role lead

Responsible Party

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Andrei Y. Hancharou

Head of the Laboratory for Immunology and Cellular Biotechnology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander V. Prokharau, Prof.

Role: STUDY_DIRECTOR

Belarussian State Medical University, Minsk, Belarus

Andrei Y Hancharou, Dr.

Role: STUDY_DIRECTOR

The Republican Research and Practical Center for Epidemiology and Microbiology

Locations

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Minsk City Clinical Oncologic Dispensary

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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RRPCEM_DC1

Identifier Type: -

Identifier Source: org_study_id

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