Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer
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
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 9, 2017
CompletedFirst Submitted
Initial submission to the registry
April 11, 2017
CompletedFirst Posted
Study publicly available on registry
April 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2019
CompletedDecember 3, 2019
December 1, 2019
2.3 years
April 11, 2017
December 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with PR or CR at 1 year
1 year PR/CR
1 year
Number of Participants Who Survived at 1 Year
1 year overall survival
1 year
Secondary Outcomes (5)
Antigen-specific immune response
1 year
Circulating tumor cells count
1 year
Immune response
1 year
Number of Participants Who Survived at 2 Years
2 years
Number of Participants Who Survived at 3 Years or more
3 years
Study Arms (3)
Dendritic cells lysate-pulsed group
EXPERIMENTALPatients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate
Control group
NO INTERVENTIONPatients treated according to clinical protocols
Dendritic cells peptide-pulsed group
EXPERIMENTALPatients treated according to clinical protocols plus autologous dendritic cells, pulsed with MUC-1/WT-1 peptides
Interventions
Eligibility Criteria
You may qualify if:
- histologically or cytologically confirmed pancreatic cancer (adenocarcinoma);
- HLA-A2 expression by tumor cells;
- WT-1/MUC-1 expression by tumor cells.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minsk City Clinical Oncologic Dispensary
Minsk, 220000, Belarus
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Laboratory for Immunology and Cellular Biotechnology
Study Record Dates
First Submitted
April 11, 2017
First Posted
April 14, 2017
Study Start
January 9, 2017
Primary Completion
May 3, 2019
Study Completion
May 23, 2019
Last Updated
December 3, 2019
Record last verified: 2019-12