drugset / Trial / NCT01446731
Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized phase II trial including 40 patients with castration resistant metastatic cancer prostate (CRMPC). Patients will be randomized between treatment with a dendritic cell vaccine plus docetaxel and docetaxel alone. The primary objective is to evaluate the vaccine specific immune response and patients will be evaluated with blood tests and DTH reactions during the treatment course. Secondary objectives are to evaluate clinical response by objective response (RECIST-criteria, 18F-NaF-PET/CT scan), PSA response, pain response and finally we determine time to progression and overall survival.
Timeline
- Start
- 2011-10
- Primary completion
- 2015-08
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mRNA transfected dendritic cell | Cell therapy | 5e+06 cells | Other |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |