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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Vaccine therapy may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate the white blood cells to kill tumor cells.
PURPOSE: This randomized phase II trial is studying radiation therapy, vaccine therapy, and interleukin-2 to see how well they work compared to radiation therapy alone in treating patients with prostate cancer.
- Compare immunologic response, as measured by the increase in prostate-specific antigen (PSA)-specific T-cell precursors, in patients with localized prostate cancer treated with vaccine comprising recombinant vaccinia-PSA and rV-B7.1 plus recombinant fowlpox-PSA vaccine, sargramostim (GM-CSF), and low-dose interleukin-2 (IL-2) vs no vaccine regimen.
- Determine the safety and tolerability of this regimen in combination with radiotherapy in these patients.
- Compare the toxic effects of IL-2 in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to planned radiotherapy (irradiation alone vs irradiation and radioactive implant) and planned hormonal therapy (yes vs no). Patients are randomized to treatment arms I or II and, once accrual on these arms is complete, up to 20 patients (9-10 HLA-A2 positive) are accrued to arm III.
- Arm I: Patients receive vaccine comprising recombinant vaccinia-PSA admixed with rV-B7.1 subcutaneously (SC) on day 2. On days 30, 58, 86, 114, 142, 170, and 198, patients receive recombinant fowlpox-PSA vaccine SC. Beginning on day 86, patients undergo radiotherapy 5 days a week with total duration dependent upon whether patient undergoes radiotherapy alone or radiotherapy plus brachytherapy. Patients receive sargramostim (GM-CSF) SC on days 1-4, 29-32, 57-60, 85-88, 113-116, 141-144, 169-172, and 197-200. Patients receive low-dose interleukin-2 SC on days 8-12, 36-40, 64-68, 91-95, 120-124, 148-152, 176-180, and 204-208.
- Arm II: Patients undergo radiotherapy 5 days a week with total duration dependent upon whether patient undergoes radiotherapy alone or radiotherapy plus brachytherapy.
- Arm III: Patients undergo radiotherapy and receive recombinant vaccinia-PSA admixed with rV-B7.1 vaccine and GM-CSF as in arm I. Patients also receive a lower dose of IL-2 SC on days 8-21, 36-49, 64-77, 91-104, 120-133, 148-161, 176-189, and 204-217.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 13 years.
PROJECTED ACCRUAL: A total of 48-49 patients (19 for arm I, 11 for arm II, and 18-19 for arm III) will be accrued for this study within 10-15 months.
Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment
aldesleukin, recombinant fowlpox-prostate apecific antigen vaccine, recombinant vaccinia prostate-specific antigen vaccine, recombinant vaccinia-B7.1 vaccine, sargramostim, brachytherapy, radiation therapy
NCI - Center for Cancer Research
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:56:47-0400
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