Status:
COMPLETED
Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
National Cancer Center, Korea
Conditions:
Prostatic Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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 initia...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01171729
Start Date
July 1 2006
End Date
May 1 2010
Last Update
August 11 2010
Active Locations (2)
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1
National Cancer Center
Gyeonggi-do, 323 Ilsan-ro Ilsandong-gu Goyang-si, South Korea, 410-769
2
Samsung Medical Center
Seoul, Gangnam-Gu, Ilwon-Dong, South Korea, 135-710