drugset / Trial / NCT01446731

Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer

NCT01446731 ↗

Phase 2 Completed 43 enrolled Inge Marie Svane
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

EvaluationDrugModalityDoseRoute
Subject mRNA transfected dendritic cell Cell therapy 5e+06 cells Other
Background Docetaxel Small molecule 75 mg/m2 Intravenous

Indications