Ignite Creation Date:
2024-05-06 @ 7:59 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02649829
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2015-12-07
Brief Title:
Autologous Dendritic Cell Vaccination in Mesothelioma
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
First-line Immunotherapy Using Wilms Tumor Protein 1 WT1-Targeted Dendritic Cell Vaccinations for Malignant Pleural Mesothelioma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
MESODEC
Brief Summary:
In this multicenter phase III trial dendritic cells DCs loaded with the mesothelioma-associated tumor antigen WT1 will be used in conjunction with conventional chemotherapy for the frontline treatment of malignant pleural mesothelioma MPM The general objective is to provide the first-in-human experimental demonstration that the combination of platinumpemetrexed-based chemotherapy with WT1-targeted DC vaccination is feasible and safe and enables the induction of both systemic and in situ mesothelioma-specific immune responses in patients with MPM
Detailed Description:
Malignant pleural mesothelioma MPM is a highly aggressive and in virtually all cases fatal cancer that is tightly associated with prior asbestos exposure Despite some improvement over time the prognosis of patient diagnosed with MPM remains dismal with a median overall survival from diagnosis of only 12 months
In this single arm phase III trial the investigators want to demonstrate the feasibility and safety of WT1-targeted dendritic cell vaccination in MPM patients as frontline treatment in conjunction with first line platinumpemetrexed-based chemotherapy and the induction of both systemic and in situ mesothelioma-specific immune responses During three years of recruitment the investigators aim at including 20 patients diagnosed with histologically proven epithelial MPM WHO grade 0-1 who are able to undergo leukapheresis chemotherapy immunotherapy and pleurectomydecortication PD in case of resectable disease Patients who underwent prior treatment for MPM or with a history of another malignancy within the last five years will be excluded
The intention of this study is to administer four vaccine doses in combination with standard of care of four 3-weekly cytoreductive platinumpemetrexed-based chemotherapy cycles to each participant and prior to surgery PD in the case of resectable MPM Patients will receive four 3-weekly intradermal vaccinations with autologous WT1 messenger mRNA-loaded dendritic cells V1-4 at day 14 after the start of each chemotherapy cycle CT1-4
The dendritic cell therapy product will be generated and administered in the Antwerp University Hospital more specifically the Center for Cell Therapy and Regenerative Medicine CCRG and the Division of Hematology both headed by Prof Zwi Berneman
The DC vaccines will be under embargo from release until the safety and quality control test results have become available and all release criteria have been met A detailed overview of all applicable release criteria is provided in the investigational medicinal product dossier The embargo period generally lasts 3 weeks counting from the day of cryopreservation ie 8 days after leukapheresis
Recruitment started in August 2017 Study-related follow-up of the included patients is intended to be until 90 days after final DC vaccine administration or 22 months after diagnosis whichever occurs later In addition to feasibility and safety of the chemoimmunotherapy schedule the investigators will look for the time to progression TTP progression-free survival PFS overall survival OS systemic immunogenicity and local immunogenicity
In this single arm phase III trial the investigators want to demonstrate the feasibility and safety of WT1-targeted dendritic cell vaccination in MPM patients as frontline treatment in conjunction with first line platinumpemetrexed-based chemotherapy and the induction of both systemic and in situ mesothelioma-specific immune responses During three years of recruitment the investigators aim at including 20 patients diagnosed with histologically proven epithelial MPM WHO grade 0-1 who are able to undergo leukapheresis chemotherapy immunotherapy and pleurectomydecortication PD in case of resectable disease Patients who underwent prior treatment for MPM or with a history of another malignancy within the last five years will be excluded
The intention of this study is to administer four vaccine doses in combination with standard of care of four 3-weekly cytoreductive platinumpemetrexed-based chemotherapy cycles to each participant and prior to surgery PD in the case of resectable MPM Patients will receive four 3-weekly intradermal vaccinations with autologous WT1 messenger mRNA-loaded dendritic cells V1-4 at day 14 after the start of each chemotherapy cycle CT1-4
The dendritic cell therapy product will be generated and administered in the Antwerp University Hospital more specifically the Center for Cell Therapy and Regenerative Medicine CCRG and the Division of Hematology both headed by Prof Zwi Berneman
The DC vaccines will be under embargo from release until the safety and quality control test results have become available and all release criteria have been met A detailed overview of all applicable release criteria is provided in the investigational medicinal product dossier The embargo period generally lasts 3 weeks counting from the day of cryopreservation ie 8 days after leukapheresis
Recruitment started in August 2017 Study-related follow-up of the included patients is intended to be until 90 days after final DC vaccine administration or 22 months after diagnosis whichever occurs later In addition to feasibility and safety of the chemoimmunotherapy schedule the investigators will look for the time to progression TTP progression-free survival PFS overall survival OS systemic immunogenicity and local immunogenicity
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