Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 Vaccine in Patients with Newly Diagnosed Advanced Adenomas
In this study, we are exploring a new approach to prevention of colon cancer. We are testing a vaccine that we hope could prevent polyps from developing into cancer and prevent polyps from recurring.
The concept is to stimulate the immune system to identify changed MUC1 on cells that are growing into polyps or transforming into cancer and to destroy those cells, thereby protecting against the development of new polyps or cancer.
The primary purpose is to compare the response of the immune system to the MUC1 vaccine versus placebo (an inactive substance). Participants will receive 4 doses of vaccine, administered at baseline week 0, at 2 weeks and at 10 weeks and a booster at week 53.The vaccine or placebo will be administered subcutaneously.
Participants will also visit the clinic to complete questionnaires, give blood samples and will also be contacted by phone between clinic visits by a research coordinator.
Volunteers must be between 40-70 years old
40 - 70 years of age or older
Jessica Hernández, RN, MSN