A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer
Summary
Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Androgens can cause the growth of prostate cancer cells. Drugs, such as bicalutamide and goserelin, may stop the adrenal glands from making androgens in patients whose tumor cells continue to grow. Giving vaccine therapy together with GM-CSF and, when needed, androgen ablation may be a more effective treatment for prostate cancer. This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with prostate cancer that progressed after surgery and/or radiation therapy.
Timeline
- Start
- 2006-02
- Primary completion
- 2010-10
- Completion
- 2010-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PROSTVAC-F | Vaccine | — | Subcutaneous |
| Subject | PROSTVAC-V | Vaccine | — | Subcutaneous |
| Subject | sargramostim | Protein / enzyme biologic | — | Subcutaneous |
| Background | Bicalutamide | Other / unclassified | — | Oral |
| Background | Goserelin | Other / unclassified | — | Subcutaneous |