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Breast Cancer Neoantigen Vaccination With Autologous Dendritic Cells

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ClinicalTrials.gov Identifier: NCT04105582
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Fundación Salud de los Andes
Information provided by (Responsible Party):
Universidad Nacional de Colombia

Brief Summary:
In this project, the investigators propose the first clinical study in Colombia of vaccination of patients with triple-negative breast cancer (TNBC) using synthetic peptides that contain mutations of the tumor itself that will be presented to the immune system by autologous dendritic cells to assess immunogenicity and safety of this type of personalized vaccine. Achieving the specific objectives set out in this project will mean that the investigators can validate in Colombia the experimental design necessary to identify exclusive epitopes in the tumors of the participants in this study, and also that have been able to demonstrate the safety and immunogenicity of these vaccines.

Condition or disease Intervention/treatment Phase
Breast Cancer Triple Negative Breast Cancer Biological: Neo-antigen pulsed Dendritic cell Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase I Clinical Study of Immunotherapy With Personalized Synthetic Vaccines in Patients With Triple Negative Breast Cancer
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Neo-antigen pulsed Dendritic cell
Autologous dendritic cells pulsed with tumor-specific neo-antigen (synthetic peptide)
Biological: Neo-antigen pulsed Dendritic cell
Patients that have already finished their conventional treatment (chemotherapy and/or surgery) will be vaccinated with dendritic cells pulsed with synthetic peptide




Primary Outcome Measures :
  1. Adverse effects and Safety [ Time Frame: One year after innoculation ]
    Number of participants with a treatment-related adverse event as associated with dendritic cells and neo-antigen inoculation assessed by CTCAE v4.0


Secondary Outcome Measures :
  1. Neoantigen Immunogenicity [ Time Frame: 6 months after last innoculation ]
    Measurement of T cell response against tumor-specific neo-antigen assessed by interferon gamma release by ELISPOT or ELISA of in vitro culture of T cells and mutated peptide-pulsed dendritic cells, normalized against wild type peptide.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be a patient who is prescribed as a treatment for her cancer initiating neo-adjuvant chemotherapy with Doxorubicin / cyclophosphamide (A / C) administered prior to cycles with Taxanes and followed by surgery to remove the tumor.
  • Be between 18 and 75 years old.
  • That the patient agrees to participate in the Clinical Study prior to the start of chemotherapy.
  • Have free venous access.
  • Signature of informed consent.

Exclusion Criteria:

  • Heart disease.
  • Diabetes
  • Renal impairment
  • Coagulation disorders
  • Have been hospitalized in the last month
  • Have another active tumor with the exception of skin tumors of the squamous-cell or basal-cell carcinoma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105582


Contacts
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Contact: Carlos A Parra-Lopez, MD PhD 5713165000 ext 15039 caparral@unal.edu.co
Contact: Ricardo Gonzalez 5713165000 ext 15016 rgonzalezc@unal.edu.co

Locations
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Colombia
Universidad Nacional de Colombia Recruiting
Bogota, Cundinamarca, Colombia, 111321
Contact: Carlos A parra-Lopez, MD PhD    3023742804    caparral@unal.edu.co   
Principal Investigator: Calos A Parra-Lopez, MD PhD         
Sub-Investigator: David A Bernal-Estevez, MD PhD         
Universidad Nacional de Colombia Recruiting
Bogota, Cundinamarca, Colombia, 111321
Contact: Carlos A parra-Lopez, MD PhD    3023742804    caparral@unal.edu.co   
Principal Investigator: Calos A Parra-Lopez, MD PhD         
Sub-Investigator: David A Bernal Estevez, MD PhD         
Sponsors and Collaborators
Universidad Nacional de Colombia
Fundación Salud de los Andes
Investigators
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Principal Investigator: Carlos A Parra-Lopez, MD PhD Full Professor School of Medicine. Microbiology Department.

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Responsible Party: Universidad Nacional de Colombia
ClinicalTrials.gov Identifier: NCT04105582     History of Changes
Other Study ID Numbers: TEBICA002
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are not going to share individual participant data (IPD)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad Nacional de Colombia:
Dendritic cells
Neo-antigen
Personalized medicine
immunotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases