drugset / Trial / NCT00698711

Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21

NCT00698711 ↗

Phase 1 Completed 15 enrolled Memorial Sloan Kettering Cancer Center
NaSingle-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 foreign substances. The 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 given into or under the skin. It is made up of several parts. The first part is MUC-2, a protein present in many cancers, especially prostate cancer. MUC-2 is attached to a material called KLH or keyhole limpet hemocyanin. KLH is purified from a snail- like marine mollusk called a keyhole limpet and has been used for many years to boost immune responses in animals and in people. Attaching MUC-2 to KLH helps the immune system react to MUC-2. The mixture of MUC-2 attached to KLH is in turn mixed with a material called QS21, from the bark of a tree, which also helps the immune system to make more cancer- fighting cells. A vaccine like the one you will receive has been given to laboratory animals and been shown to produce an immune response in these animals.

Timeline

Start
1997-11
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject MUC-2-KLH Unknown 3 ug Subcutaneous
Subject MUC-2-KLH Unknown 10 ug Subcutaneous
Subject MUC-2-KLH Unknown 30 ug Subcutaneous
Subject MUC-2-KLH Unknown 100 ug Subcutaneous

Indications