Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114631
• Other study ID #: RRPCEM_DC1
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 9, 2017
• Est. completion date: May 23, 2019

Study information

• Verified date: December 2019
• Source: The Republican Research and Practical Center for Epidemiology and Microbiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 23, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dendritic Cells
• Pancreatic Neoplasms

Intervention

Biological:
• Dendritic cells pulsed with tumor lysate

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

Locations

Country	Name	City	State
Belarus	Minsk City Clinical Oncologic Dispensary	Minsk

Sponsors (2)

Lead Sponsor	Collaborator
The Republican Research and Practical Center for Epidemiology and Microbiology	Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with PR or CR at 1 year	1 year PR/CR	1 year
Primary	Number of Participants Who Survived at 1 Year	1 year overall survival	1 year
Secondary	Antigen-specific immune response	The increase of antigen-specific T-cells	1 year
Secondary	Circulating tumor cells count	Decrease of EpCAM+CD45- circulating tumor cells count	1 year
Secondary	Immune response	Decrease of T-regulatory cells	1 year
Secondary	Number of Participants Who Survived at 2 Years	2 year overall survival	2 years
Secondary	Number of Participants Who Survived at 3 Years or more	3 year overall survival	3 years