Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Prostatic Cancer

Intervention / Treatment
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* Biological: Autologous dendritic cell


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Autologous dendritic cell|Autologous dendritic cells pulsed with prostate cancer antigen and KLH|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | weeks 0, 12, 21 | 
| Clinical response | Clinical course of participants as measured by bone scans and CT | week 0, 12, 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, PSA, Hormone refractory prostatic cancer