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Radiation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer

2014-08-27 03:56:47 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

- 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.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

aldesleukin, recombinant fowlpox-prostate apecific antigen vaccine, recombinant vaccinia prostate-specific antigen vaccine, recombinant vaccinia-B7.1 vaccine, sargramostim, brachytherapy, radiation therapy

Location

NCI - Center for Cancer Research
Bethesda
Maryland
United States
20892

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:47-0400

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Medical and Biotech [MESH] Definitions

Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.

The large scale production of pharmaceutically important and commercially valuable RECOMBINANT PROTEINS.

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

Techniques utilizing cells that express RECOMBINANT FUSION PROTEINS engineered to translocate through the CELL MEMBRANE and remain attached to the outside of the cell.

The type species of the genus AVIPOXVIRUS. It is the etiologic agent of FOWLPOX.

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