Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer
Status:
Completed
Trial end date:
2017-06-08
Target enrollment:
Participant gender:
Summary
Background:
- Flutamide is an approved drug for prostate cancer that blocks the effects of
testosterone on prostate cancer cells and may slow the progression of the disease.
- The vaccine in this study consists of a priming vaccine called PROSTVAC (rilimogene
galvacirepvec/rilimogene glafolivec) -V/TRICOM (triad of costimulatory molecules), made
from vaccinia virus, and a boosting vaccine called PROSTVAC-F/TRICOM, made from fowlpox
virus. DNA (Deoxyribonuceic acid) is inserted into the priming and boosting vaccine
viruses to cause production of proteins that enhance immune activity and also to produce
prostate specific antigen (PSA) a protein that is normally produced by the patients
tumor cells.
- GM-CSF (granulocyte macrophage colony stimulating factor), given along with the vaccine,
is a chemical that boosts the immune system. It is used in this study to try to increase
the usefulness of the vaccine by increasing the number of immune cells at the
vaccination site.
Objectives:
-To determine if treatment with a prostate cancer vaccine plus flutamide is more effective
than flutamide alone in delaying disease progression in patients with prostate cancer.
Eligibility:
- Patients 18 years of age and older with androgen-insensitive prostate cancer that has
not spread beyond the prostate gland.
- Patients with a rising PSA (prostatic specific antigen) who have already been treated
with anti-iandrogen therapy (either bicalutamide or nilutamide).
Design:
- There are two treatment groups in this study. Group A receives only flutamide; group B
receive flutamide plus vaccine.
- Patients in both groups receive flutamide by mouth three times a day.
- Patients in group B receive PROSTVAC-V/TRICOM on day 1 and PROSTVAC-F/TRICOM on day 29
and again every 4 weeks. All vaccines are given as injections under the skin.
- Patients have blood tests for PSA levels every month and scans every 3 months until the
disease worsens.
- After 3 months of therapy, patients receiving in group A (flutamide alone) may cross
over to receive vaccine if they develop a rising PSA and scans show no sign of disease
spread. Patients in group B (flutamide plus vaccine) stop flutamide and may continue
vaccine therapy. At this point patients may continue to receive treatment until the
disease progresses or PSA levels rise....