Vaccine Therapy With or Without Docetaxel in Treating Patients With Metastatic Prostate Cancer
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without docetaxel in treating patients who have metastatic prostate cancer.
|Prostate Cancer||Biological: recombinant fowlpox-prostate specific antigen vaccine Biological: recombinant vaccinia prostate-specific antigen vaccine Biological: recombinant vaccinia-B7.1 vaccine Biological: sargramostim Drug: docetaxel||Phase 2|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of Pox Vector PSA Vaccine With Concurrent Docetaxel Versus Pox Vector Vaccine Followed by Docetaxel in Metastatic Androgen Independent Prostate Cancer|
|Study Start Date:||August 2002|
|Study Completion Date:||October 2007|
- 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 vaccine/chemotherapy courses.
- 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 unacceptable toxicity.
PROJECTED ACCRUAL: A total of 28 patients (14 per treatment arm) will be accrued for this study within 9-10 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045227
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Philip M. Arlen, MD||National Cancer Institute (NCI)|