This is an open label, Phase I/IIa trial of immunotherapy with CreaVax-PC as treatment in men with hormone-Refractory Metastatic Prostate Cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Autologous dendritic cells pulsed with prostate cancer antigen and KLH
National Cancer Center
Gyeonggi-do, 323 Ilsan-ro Ilsandong-gu Goyang-si, South Korea
Samsung Medical Center
Seoul, Gangnam-Gu, Ilwon-Dong, South Korea
PSA increment and absolute PSA response
PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks
Time frame: 12 weeks
Time to Progression
Time frame: DC Injection to time to progression or death
Overall Survival
Time frame: Patients will be followed until death
Immune Response(DTH response, Interferon-gamma Elispot assay, proliferation assay, ELISA)
Time frame: weeks 0, 12, 21
Clinical response
Clinical course of participants as measured by bone scans and CT
Time frame: week 0, 12, 21
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