Clinical trial · Interventional
Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer
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
NCT01171729CI-TRIAL-00003782completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open label, Phase I/IIa trial of immunotherapy with CreaVax-PC as treatment in men with hormone-Refractory Metastatic Prostate Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous dendritic cell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- PSA increment and absolute PSA response
- timeFrame
- 12 weeks
- description
- PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks
Secondary outcomes (4)
- measure
- Time to Progression
- timeFrame
- DC Injection to time to progression or death
- measure
- Overall Survival
- timeFrame
- Patients will be followed until death
- measure
- Immune Response(DTH response, Interferon-gamma Elispot assay, proliferation assay, ELISA)
- timeFrame
- weeks 0, 12, 21
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.