A Phase I/IIa 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
CreaVax-PC consisted of antigen (PSA, PAP and KLH) primed dendritic cell is an
investigational product designed to activate a man's 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA increment and absolute PSA response
PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks
J C W, M.D,Ph.D
Samsung Medical Center
Korea: Food and Drug Administration