Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer
- 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-V/TRICOM, made from vaccinia virus, and a boosting vaccine called PROSTVAC-F/TRICOM, made from fowlpox virus. DNA 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 patient s tumor cells.
- GM-CSF, 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.
-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.
- 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 who have already been treated with anti-iandrogen therapy (either bicalutamide or nilutamide).
- 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....
Biological: recombinant fowlpox-prostate apecific antigen vaccine
Biological: recombinant vaccinia prostate specific antigen vaccine
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial Combining Vaccine Therapy With PROSTVAC/TRICOM and Flutamide vs. Flutamide Alone in Men With Androgen Insensitive, Non-Metastatic (D0.5) Prostate Cancer|
- Time to treatment failure [ Designated as safety issue: No ]
- Time to development of metastatic disease [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||February 2007|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients receive flutamide orally 3 times a day on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising PSA levels) without metastatic disease (as evidenced on scans), may receive vaccine treatment as defined in arm II beginning 4 weeks after flutamide therapy is discontinued.
Experimental: Arm II
Patients receive flutamide orally 3 times a day on days 1-28. Patients also receive recombinant vaccinia PSA vaccine subcutaneously (SC) on day 1 of course 1 only and recombinant fowlpox PSA vaccine SC on day 1 of all subsequent courses. Patients receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising PSA levels), discontinue flutamide but may continue to receive vaccine treatment.
Given orallyBiological: Sargramostim
Given subcutaneouslyBiological: recombinant fowlpox-prostate apecific antigen vaccine
Given subcutaneouslyBiological: recombinant vaccinia prostate specific antigen vaccine
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|Contact: Mary P Pazdur, C.R.N.P.||(301) firstname.lastname@example.org|
|Contact: Ravi A Madan, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|United States, New Jersey|
|Cancer Institute of New Jersey||Recruiting|
|New Brunswick, New Jersey, United States, 08901|
|Principal Investigator:||Ravi A Madan, M.D.||National Cancer Institute (NCI)|