drugset / Trial / NCT00705835

Vaccine Therapy of Prostate Cancer Patients With Recombinant Soluble Prostate-Specific Membrane Antigen (Rs-PSMA) Plus the Immunological Adjuvant Alhydrogel

NCT00705835

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this research is to help us study a vaccine treatment for patients with prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections and other diseases, such as cancer. Your immune system is made up of many different types of cells which fight infection and disease in your body. A vaccine may stimulate the immune system to destroy the cancer cells. It may also help to slow the growth of the cancer. The vaccine is a solution given as an injection into or under the skin. It is made up of several parts. The first part is PSMA, a protein present in many cancers, especially prostate cancer. It is referred to as rsPSMA when made in a laboratory for this study and is mixed with a material called Alhydrogel® (aluminum hydroxide suspension) which helps the immune system to make more cancer-fighting cells.

Timeline

Start
2003-01
Primary completion
2008-01
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Aluminum hydroxide Unknown 0.5 mg Subcutaneous
Subject Aluminum hydroxide Unknown 1 mg Subcutaneous
Subject rsPSMA Protein / enzyme biologic 50 ug Subcutaneous
Subject rsPSMA Protein / enzyme biologic 250 ug Subcutaneous

Indications