Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

• Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology (Other)
• Overall Status: Completed
• CT.gov ID: NCT03114631
• Collaborator: Belarusian State Medical University (Other)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 28.4
• Patients Per Site Per Month: 1.1

Study Details

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

Condition or Disease	Intervention/Treatment	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

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• 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
• Actual Study Start Date: Jan 9, 2017
• Actual Primary Completion Date: May 3, 2019
• Actual Study Completion Date: May 23, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants with PR or CR at 1 year [1 year]

   1 year PR/CR

2. Number of Participants Who Survived at 1 Year [1 year]

   1 year overall survival

Secondary Outcome Measures

1. Antigen-specific immune response [1 year]

   The increase of antigen-specific T-cells

2. Circulating tumor cells count [1 year]

   Decrease of EpCAM+CD45- circulating tumor cells count

3. Immune response [1 year]

   Decrease of T-regulatory cells

4. Number of Participants Who Survived at 2 Years [2 years]

   2 year overall survival

5. Number of Participants Who Survived at 3 Years or more [3 years]

   3 year overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: RRPCEM_DC1
• First Posted: Apr 14, 2017
• Last Update Posted: Dec 3, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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, Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology: dendritic cells, pancreatic cancer, immunotherapy
• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

No Results Posted as of Dec 3, 2019