A Pilot Trial of Pox Vector PSA Vaccine With Concurrent Docetaxel Versus Pox Vector Vaccine Followed by Docetaxel in Metastatic Androgen Independent Prostate Cancer
- Compare the relative change in prostate-specific antigen (PSA)-specific T-cell
precursors (CD8) from baseline to day 85 in patients with metastatic
androgen-independent prostate cancer treated with a vaccination regimen comprising
fowlpox-PSA vaccine, recombinant rV-B7.1 vaccine, recombinant vaccinia-PSA vaccine, and
sargramostim (GM-CSF) with or without docetaxel.
- Compare the safety of these regimens in these patients.
- Compare clinical activity of these regimens in these patients.
- Determine the immunologic effects in these patients after additional
- Measure CD4 T-cell responses to the vaccine in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms after
receiving priming vaccinations.
- Priming vaccinations: All patients receive recombinant vaccinia-prostate-specific
antigen (PSA) vaccine subcutaneously (SC) and recombinant rV-B7.1 vaccine SC on day 1
and sargramostim (GM-CSF) SC on days 1-4. Patients then receive fowlpox-PSA vaccine
(F-PSA) SC on day 15 and GM-CSF SC on days 15-18.
- Arm I: Patients receive docetaxel IV over 30 minutes on days 29, 36, and 43; F-PSA SC
on day 30; and GM-CSF SC on days 30-33. Treatment repeats beginning on day 56 for one
more course. Patients who do not have disease progression at day 85 receive docetaxel
weekly for 3 weeks and F-PSA on day 1 of each course. Courses repeat every 4 weeks in
the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive F-PSA SC on days 29 and 57 and GM-CSF SC on days 29-32 and
57-60. Patients who show disease progression after day 85 either radiographically or by
rising PSA stop receiving the vaccine and may receive docetaxel weekly for 3 weeks.
Chemotherapy repeats every 4 weeks in the absence of disease progression or
PROJECTED ACCRUAL: A total of 28 patients (14 per treatment arm) will be accrued for this
study within 9-10 months.
Allocation: Randomized, Primary Purpose: Treatment
Philip M. Arlen, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|