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| Name | Class |
|---|---|
| National Cancer Center, Korea | OTHER_GOV |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous dendritic cell | Biological | Autologous dendritic cells pulsed with prostate cancer antigen and KLH |
|
| Measure | Description | Time Frame |
|---|---|---|
| PSA increment and absolute PSA response | PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | DC Injection to time to progression or death | |
| Overall Survival | Patients will be followed until death | |
| Immune Response(DTH response, Interferon-gamma Elispot assay, proliferation assay, ELISA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J C W, M.D,Ph.D | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Gyeonggi-do | 323 Ilsan-ro Ilsandong-gu Goyang-si | 410-769 | South Korea | ||
| Samsung Medical Center |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| weeks 0, 12, 21 |
| Clinical response | Clinical course of participants as measured by bone scans and CT | week 0, 12, 21 |
| Seoul |
| Gangnam-Gu, Ilwon-Dong |
| 135-710 |
| South Korea |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |