Ignite Creation Date:
2024-05-06 @ 7:59 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02649582
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2015-01-23
Brief Title:
Adjuvant Dendritic Cell-immunotherapy Plus Temozolomide in Glioblastoma Patients
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Adjuvant Dendritic-Cell Immunotherapy Plus Temozolomide Following Surgery and Chemoradiation in Patients With Newly Diagnosed Glioblastoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
ADDIT-GLIO
Brief Summary:
In this phase III trial the primary objective is to determine overall and progression-free survival of patients with newly diagnosed glioblastoma when autologous Wilms tumor 1 WT1 messenger mRNA-loaded dendritic cell DC vaccination is added to adjuvant temozolomide maintenance treatment following subtotal resection and temozolomide-based chemoradiation
Detailed Description:
Glioblastoma multiforme GBM a microscopically infiltrative disease is the most common malignant brain tumor worldwide Despite optimized standard of care treatment median survival and prognosis remain poor with a median survival of only 15 and five year survival after diagnosis of 5
In this single arm single centre phase III trial the investigators will determine the overall and progression free survival of patients with newly diagnosed GBM when autologous WT1 mRNA loaded dendritic cell vaccination is added to standard of care treatment During recruitment the investigators will include 20 patients with newly diagnosed histologically verified glioblastoma WHO grade IV who have received a total or subtotal resection of the tumor Patients who underwent prior radiation or chemotherapy or with a history of other malignancy will be excluded In addition to standard of care consisting of adjuvant chemoradiation with temozolomide and temozolomide maintenance patients will receive an intradermal vaccination with autologous WT1 mRNA-loaded dendritic cells commencing 1 week after radiotherapy 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 headed by Prof Zwi Berneman and the Division of Hematology
Recruitment began in December 2015 and is intended to continue until the end of 2024 or when 20 patients are enrolled After a follow-up period until 90 days after final DC vaccine administration or 24 months after apheresis whichever occurs later overall and progression free survival analysis will be performed and this will be compared with the published data of standard of care treatment without vaccination In addition the investigators will look for feasibility incidence of adverse events and immunogenicity
In this single arm single centre phase III trial the investigators will determine the overall and progression free survival of patients with newly diagnosed GBM when autologous WT1 mRNA loaded dendritic cell vaccination is added to standard of care treatment During recruitment the investigators will include 20 patients with newly diagnosed histologically verified glioblastoma WHO grade IV who have received a total or subtotal resection of the tumor Patients who underwent prior radiation or chemotherapy or with a history of other malignancy will be excluded In addition to standard of care consisting of adjuvant chemoradiation with temozolomide and temozolomide maintenance patients will receive an intradermal vaccination with autologous WT1 mRNA-loaded dendritic cells commencing 1 week after radiotherapy 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 headed by Prof Zwi Berneman and the Division of Hematology
Recruitment began in December 2015 and is intended to continue until the end of 2024 or when 20 patients are enrolled After a follow-up period until 90 days after final DC vaccine administration or 24 months after apheresis whichever occurs later overall and progression free survival analysis will be performed and this will be compared with the published data of standard of care treatment without vaccination In addition the investigators will look for feasibility incidence of adverse events and immunogenicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None