Prostatic Cancer
Conditions
Keywords
Prostate cancer, PSA, Hormone refractory prostatic cancer
Brief summary
This is an open label, Phase I/IIa 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 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.
Interventions
BIOLOGICALAutologous dendritic cell
Autologous dendritic cells pulsed with prostate cancer antigen and KLH
Sponsors
National Cancer Center, Korea
Samsung Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\) Histological confirmed prostatic carcinoma patient * 2\) Hormone non-respondence ex1) Although treatment PSA ≥ 5ng/ml ex2) PSA level were measured two times ex3) Prior one year radiology were processed * 3\) Just 18 years over * 4\) Has a score ≤1 on the ECOG Performance Scale * 5\) Expected survival life time ≥ 6month * 6\) Adequate bone marrow function hemoglobin ≥ 10.0g/dL , leukocyte count ≥ 4,000/mm3 thrombocyte ≥ 100,000/mm3 * 7\) Adequate blood coagulation function PT(INR) \< 1.5, aPTT\< 1.5 x control * 8\) Adequate kidney function Normal blood upper level Creatinine ≤ 1.5 times * 9\) Adequate liver function Normal blood upper level AST/ALT ≤ 1.5 times * 10\) Autoimmune antibody system don't have disorder ex) anti-nuclear antibody, anti-thyroglobulin antibody negativity * 11\) Person who didn't treat prior 6 weeks operation, radiotherapy treatment,immunotherapy or chemotherapy * 12\) Patient who voluntarily participated clinical trial and confirmed a written consent
Exclusion criteria
* 1\) Having other malignancy or previous history of malignancy * 2\) Brain metastases patient * 3\) Having autoimmune disease or its history * 4\) Pyrexia, rigor, leukocytosis infectious disease * 5\) HBsAg, anti-HCV, HIV positive patient * 6\) Myocardial infarction, cardiac insufficiency, other severe heart disease and non-controlled hypertension * 7\) Severe and active medical disease * 8\) Mental history disease or epilepsy * 9\) Patients participated other clinical trial within 4 weeks * 10\) Patients impossible to participate this trial by investigator's decision * 11\) Patients who received immunosuppressant such as steroid, cyclosporin A, azathioprine within 6 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA increment and absolute PSA response | 12 weeks | PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | weeks 0, 12, 21 | — |
| Clinical response | week 0, 12, 21 | Clinical course of participants as measured by bone scans and CT |
Countries
South Korea
Outcome results
None listed