Ignite Creation Date:
2024-05-05 @ 10:45 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01171729
Status:
COMPLETED
Last Update Posted:
2010-08-11
First Post:
2010-07-27
Brief Title:
Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
A Phase IIIa Study of Autologous Cell-based Vaccine Therapy With CreaVax-PC in Hormone-Refractory Metastatic Prostate Cancer Patients With PSA Relapse to Evaluate the Safety and Efficacy
Status:
COMPLETED
Status Verified Date:
2010-07
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:
This is an open label Phase IIIa trial of immunotherapy with CreaVax-PC as treatment in men with hormone-Refractory Metastatic Prostate Cancer
Detailed Description:
CreaVax-PC consisted of antigen PSA PAP and KLH primed dendritic cell is an investigational product designed to activate a mans immune response so they can detect prostate cancer cells and initiate an immune response against prostate cancer antigens
If patients decide to participate and are eligible they will be enrolled in the study and will receive active product CreaVax-PC In detail patients will receive CreaVax-PC injection at intervals of 3 weeks maximum 6 times during 21 weeks PSA increase rate is a primary evaluation variables and tumor suppression effect is secondary evaluation variables We also evaluate time to progression overall survival and immune response
If patients decide to participate and are eligible they will be enrolled in the study and will receive active product CreaVax-PC In detail patients will receive CreaVax-PC injection at intervals of 3 weeks maximum 6 times during 21 weeks PSA increase rate is a primary evaluation variables and tumor suppression effect is secondary evaluation variables We also evaluate time to progression overall survival and immune response
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