drugset / Trial / NCT01145508

Docetaxel and Prednisone With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

NCT01145508

Phase 2 Terminated 10 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how well docetaxel and prednisone with or without vaccine therapy works in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from an antigen may help the body build an effective immune response to kill tumor cells. It is not yet known whether docetaxel and prednisone are more effective with or without vaccine therapy in treating prostate cancer.

Timeline

Start
2010-08
Primary completion
2012-10
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject PROSTVAC-V Vaccine Subcutaneous
Subject Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine Unknown Subcutaneous
Background Docetaxel Small molecule Intravenous
Background Prednisone Other / unclassified Oral