Pilot Study of Oral 852A for Elimination of High-Grade Dysplasia in Barrett's Esophagus
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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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female, 18 years or older
Documented Barrett's esophagus with high-grade dysplasia with diagnosis confirmed by the Pathology Department at the University of Chicago
Laboratory parameters within the range given in the protocol.
Patients with high-grade dysplasia of the esophagus who on ultrasound of the esophagus have invasion through the muscularis mucosa
Patients who do not tolerate repeated endoscopy
Patients who are allergic to 852A or any component in its vehicle
Patients with autoimmune disease such as rheumatoid arthritis, ulcerative colitis or Crohn's disease which could be worsened by stimulating the innate immune system
Pregnant patients, and vulnerable patients who cannot or will not use contraceptives
Males who have a sexual partner who is pregnant or a vulnerable partner who cannot or will not use contraceptives.
Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication
History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
Uncontrolled intercurrent or chronic illness
Active hepatitis B or C with evidence of ongoing viral replication
Uncontrolled seizure disorder
Active coagulation disorder not controlled with medication
Congenital long QT syndrome or abnormal baseline QTc interval after Bazett's correction
Laboratory values outside of the acceptable range as given in protocol.