At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dendritic Cell Vaccination in Combination With Docetaxel for Patients With Cancer Prostate - a Randomized Phase II Study
In Brief
A Phase 2 clinical trial evaluating mRNA transfected dendritic cell and Docetaxel for Prostatic Neoplasms. Completed, enrolled 43 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Autologous monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT. 5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration).
Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).