Pilot Study of Oral 852A for Elimination of High-Grade Dysplasia in Barrett's Esophagus
Status:
Terminated
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
Barrett's esophagus with high-grade dysplasia is a premalignant condition caused by chronic
reflux of gastric contents into the esophagus. High-grade dysplasia is the same as
carcinoma-in-situ. If untreated, patients with this condition are at high risk for developing
cancer of the esophagus. Cancer of the esophagus is a miserable disease that is difficult to
treat and about 95% fatal after 5 years. To prevent progession to cancer of the esophagus
several interventions are available and they include surgery, Photofrin photodynamic therapy,
endoscopic mucosal resection and endoscopic thermal therapy. All of these modalities are
uncomfortable, expensive and have associated risks. The oral agent, 852A stimulates the
innate immune system in such a way as to eliminate early cancer. A similar dermatologic
drug(imiquimod) is approved for treating the premalignant condition, actinic keratosis. If
local therapy with imiquimod can eliminate a premalignant lesion in the skin, a similar
acting drug should be able to do the same for a premalignant lesion in the lining of the
esophagus. This study is designed to test that hypothesis.