A Phase 1/2 interventional study of Dendritic cells pulsed with tumor lysate and Dendritic cells pulsed with MUC-1/WT-1 peptides in Dendritic Cells and Pancreatic Neoplasms, sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology. Completed at 1 site in Belarus. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-12-03.
Sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology · Phase 1/2, Interventional, and Treatment
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
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).
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's enrollment of 30 is below the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →The Republican Research and Practical Center for Epidemiology and Microbiology is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate
Biological: Dendritic cells pulsed with tumor lysate
Patients treated according to clinical protocols
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
Number of Participants with PR or CR at 1 year
1 year PR/CR
Time frame: 1 year
Number of Participants Who Survived at 1 Year
1 year overall survival
Time frame: 1 year
Antigen-specific immune response
The increase of antigen-specific T-cells
Time frame: 1 year
Circulating tumor cells count
Decrease of EpCAM+CD45- circulating tumor cells count
Time frame: 1 year
Immune response
Decrease of T-regulatory cells
Time frame: 1 year
Number of Participants Who Survived at 2 Years
2 year overall survival
Time frame: 2 years
Number of Participants Who Survived at 3 Years or more
3 year overall survival
Time frame: 3 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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The Republican Research and Practical Center for Epidemiology and Microbiology