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Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

2014-08-27 03:56:20 | BioPortfolio

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent prostate cancer.

Description

OBJECTIVES: I. Determine the effect of PSA-3 peptide vaccine emulsified in Montanide ISA-51 on PSA levels in patients with recurrent prostate cancer. II. Determine the toxicity of this regimen in these patients. III. Determine whether the T lymphocyte immune response to PSA-3 and HLA-A2 antigen-presenting cells that endogenously produce PSA is increased in patients treated with this regimen. IV. Determine the duration of the PSA and/or immune responses in patients treated with this regimen. V. Correlate immune and PSA responses in patients treated with this regimen. VI. Determine the efficacy of a second (boost) vaccination with this regimen in patients with a PSA or immune response.

OUTLINE: This is a multicenter study. Patients receive PSA-3 peptide vaccine emulsified in Montanide ISA-51 subcutaneously in 2 sites on days 1, 8, 15, and 22 in the absence of unacceptable toxicity. Patients who show an immune or prostate specific antigen (PSA) response are followed until disease progression, defined as a diminution or disappearance of an immune response or 2 consecutive increases in PSA over the nadir. Patients are eligible for a second series of injections at the time of progression.

PROJECTED ACCRUAL: A total of 14-44 patients will be accrued for this study within 12-18 months.

Study Design

Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

PSA prostate cancer vaccine, incomplete Freund's adjuvant

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:20-0400

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Medical and Biotech [MESH] Definitions

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.

A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

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.

Tumors or cancer of the PROSTATE.

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