Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04879888
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2021-04-30
Brief Title:
Personalized Vaccine for Cancer Immunotherapy
Sponsor:
Universidad Nacional de Colombia
Organization:
Universidad Nacional de Colombia
Study Overview
Official Title:
Estudio clínico Fase I de Inmunoterapia Con Vacunas sintéticas Personalizadas en Pacientes Con cáncer de Mama Triple Negativo
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Due to their genetic instability breast tumors that do not express receptors for Estrogens Progestagens or amplify the Her2 neu oncogene called triple-negative breast cancer TNTC and other tumors such as melanoma non-small cell lung cancer accumulate numerous mutations that make them highly resistant to different regimens of chemo- or radiotherapy thereby generating high morbidity and mortality However immunology can turn the genetic instability of tumors into the Achilles tendon Evidence of this has been revealed in Phase I clinical studies in patients with melanoma and lung cancer in an advanced stage of metastasis treated with Ipilimumab anti-CTLA4 to decrease immunosuppression in whom peptides containing mutations presented in Major Complex molecules Histocompatibility of Class I HCM I of the tumor itself results in their recognition as foreign neo-antigens leading to the efficient destruction of the tumor by anti-tumor CD8 T lymphocytes that are amplified when they are vaccinated with these peptides
For this reason the identification of non-synonymous mutations of single amino acid and vaccination with 25 amino acid peptides that incorporate these mutations synthetic vaccines is emerging today as an alternative for immunotherapy of cancers responsible for high mortality in humans In an approach that takes 16 weeks today it is possible to go from the analysis of the tumors transcriptome which allows identifying the universe of tumor mutations to the patients vaccination with a personalized vaccine that contains neo-antigens of his tumor
TNBC is the most aggressive breast tumor representing around 25 of breast cancers in our environment While generally at least 30 of women with other types of metastatic breast cancer survive 5 years after diagnosis most patients diagnosed with metastatic CMTN die within this time The lack of selective therapies and the poor prognosis of patients with NTMC make their therapeutic management difficult so the implementation of new therapies for this type of tumor is the main focus of researchers who seek more effective and selective treatments to improve the life expectancy of patients without compromising their quality of life The genetic instability and high rate of mutations of the TNBC most likely favor the generation of neo-epitopes Still due to the immunosuppressive environment of the tumor it escapes the immunosurveillance of the immune system Despite the high mortality induced by this tumor a percentage of patients treated with neoadjuvant chemotherapy with agents such as Doxorubicin and Cyclophosphamide AC Taxanes respond to this chemotherapy regimen In particular the anti-tumor effect of AC is attributed to two things i the direct cytotoxic effect on the tumor cell ii the immunostimulation of T lymphocytes promoted by Immunogenic Cell Death ICM selectively induced by these drugs Therefore in this project we propose to carry out the first clinical study in Colombia of vaccination of patients with TNBC with synthetic peptides that contain mutations of their own tumor to evaluate the immunogenicity and safety of this type of personalized vaccine as a therapeutic alternative for this tumor Achieving the specific objectives set out in this project would mean that we have been validated in Colombia the experimental design necessary to identify unique epitopes in tumors and demonstrate the safety and immunogenicity of these vaccines We consider that having achieved the above we will have taken an important step towards the implementation in our country of the use of this type of vaccine for immunotherapy not only of TNBC but of other tumors such as glioblastoma gastric esophagus and pancreas highly fatal due to its high mutation rate
For this reason the identification of non-synonymous mutations of single amino acid and vaccination with 25 amino acid peptides that incorporate these mutations synthetic vaccines is emerging today as an alternative for immunotherapy of cancers responsible for high mortality in humans In an approach that takes 16 weeks today it is possible to go from the analysis of the tumors transcriptome which allows identifying the universe of tumor mutations to the patients vaccination with a personalized vaccine that contains neo-antigens of his tumor
TNBC is the most aggressive breast tumor representing around 25 of breast cancers in our environment While generally at least 30 of women with other types of metastatic breast cancer survive 5 years after diagnosis most patients diagnosed with metastatic CMTN die within this time The lack of selective therapies and the poor prognosis of patients with NTMC make their therapeutic management difficult so the implementation of new therapies for this type of tumor is the main focus of researchers who seek more effective and selective treatments to improve the life expectancy of patients without compromising their quality of life The genetic instability and high rate of mutations of the TNBC most likely favor the generation of neo-epitopes Still due to the immunosuppressive environment of the tumor it escapes the immunosurveillance of the immune system Despite the high mortality induced by this tumor a percentage of patients treated with neoadjuvant chemotherapy with agents such as Doxorubicin and Cyclophosphamide AC Taxanes respond to this chemotherapy regimen In particular the anti-tumor effect of AC is attributed to two things i the direct cytotoxic effect on the tumor cell ii the immunostimulation of T lymphocytes promoted by Immunogenic Cell Death ICM selectively induced by these drugs Therefore in this project we propose to carry out the first clinical study in Colombia of vaccination of patients with TNBC with synthetic peptides that contain mutations of their own tumor to evaluate the immunogenicity and safety of this type of personalized vaccine as a therapeutic alternative for this tumor Achieving the specific objectives set out in this project would mean that we have been validated in Colombia the experimental design necessary to identify unique epitopes in tumors and demonstrate the safety and immunogenicity of these vaccines We consider that having achieved the above we will have taken an important step towards the implementation in our country of the use of this type of vaccine for immunotherapy not only of TNBC but of other tumors such as glioblastoma gastric esophagus and pancreas highly fatal due to its high mutation rate
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None