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Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer

2014-08-27 03:56:06 | BioPortfolio

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as QS21 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with QS21 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with QS21 in treating patients who have prostate cancer.

Description

OBJECTIVES:

- Determine the safety of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 in patients with prostate cancer.

- Determine the antibody response in patients treated with this vaccination therapy.

- Assess post-immunization changes in PSA levels and other objective parameters of disease (radionuclide bone scan) in patients treated with this vaccination therapy.

OUTLINE: Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 subcutaneously once weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity. Patients whose antibody titers against Globo-H or MUC-2 antigens fall below 1/40 and who have no disease progression may receive a seventh vaccination after week 50.

Patients are followed every 3 months for 1 year or until biochemical relapse or radiographic disease progression.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 months.

Study Design

Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

MUC-2-Globo H-KLH conjugate vaccine, QS21

Location

Memorial Sloan-Kettering Cancer Center
New York
New York
United States
10021

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:06-0400

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Medical and Biotech [MESH] Definitions

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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.

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