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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Dendritic Cells
- Sponsor
- The Republican Research and Practical Center for Epidemiology and Microbiology
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Survived at 1 Year
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Andrei Y. Hancharou
Head of the Laboratory for Immunology and Cellular Biotechnology
The Republican Research and Practical Center for Epidemiology and Microbiology
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.
Outcomes
Primary Outcomes
Number of Participants Who Survived at 1 Year
Time Frame: 1 year
1 year overall survival
Number of Participants with PR or CR at 1 year
Time Frame: 1 year
1 year PR/CR
Secondary Outcomes
- Number of Participants Who Survived at 3 Years or more(3 years)
- Immune response(1 year)
- Antigen-specific immune response(1 year)
- Circulating tumor cells count(1 year)
- Number of Participants Who Survived at 2 Years(2 years)