Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045968
Status:
UNKNOWN
Last Update Posted:
2022-05-18
First Post:
2002-09-17
Brief Title:
Study of a Drug DCVax-L to Treat Newly Diagnosed GBM Brain Cancer
Sponsor:
Northwest Biotherapeutics
Organization:
Northwest Biotherapeutics
Study Overview
Official Title:
A Phase III Clinical Trial Evaluating DCVax-L Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme GBM
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
GBM
Brief Summary:
The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVaxR-L in patients with newly diagnosed GBM for whom surgery is indicated Patients must enter screening at a participating site prior to surgical resection of the tumor Patients will receive the standard of care including radiation and Temodar therapy and two out of three will additionally receive DCVax-L with the remaining one third receiving a placebo All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression note DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain
Detailed Description:
This Phase III trial is designed to evaluate the impact on survival time as well as safety in patients following treatment with DCVaxR-L an immunotherapy treatment for GBM The experimental therapy uses a patients own tumor lysate and white blood cells from which precursors of the dendritic cells are isolated The dendritic cell is the starter engine of the immune system The white cells are then made into dendritic cells and they are educated to teach the immune system how to recognize brain cancer cells Eligible patients will receive a series of injections of DCVax-L to activate and then boost the immune response to the tumor cells
The primary study endpoint is OS overall survival compared to external controls in newly diagnosed glioblastoma and the first secondary endpoint is OS compared to external controls in recurrent glioblastoma
Side effects reported from early trials are mostly mild and may include skin reactions of redness pain swelling at the injection site
The primary study endpoint is OS overall survival compared to external controls in newly diagnosed glioblastoma and the first secondary endpoint is OS compared to external controls in recurrent glioblastoma
Side effects reported from early trials are mostly mild and may include skin reactions of redness pain swelling at the injection site
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