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: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rogers, B.H. Gerald, M.D.
• Collaborator: 3M

Criteria

Inclusion Criteria:

1. Male or female, 18 years or older

2. Documented Barrett's esophagus with high-grade dysplasia with diagnosis confirmed by the Pathology Department at the University of Chicago

3. Laboratory parameters within the range given in the protocol.

Exclusion criteria.

1. Patients with high-grade dysplasia of the esophagus who on ultrasound of the esophagus have invasion through the muscularis mucosa

2. Patients who do not tolerate repeated endoscopy

3. Patients who are allergic to 852A or any component in its vehicle

4. Patients with autoimmune disease such as rheumatoid arthritis, ulcerative colitis or Crohn's disease which could be worsened by stimulating the innate immune system

5. Pregnant patients, and vulnerable patients who cannot or will not use contraceptives

6. Males who have a sexual partner who is pregnant or a vulnerable partner who cannot or will not use contraceptives.

7. Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication

8. 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

9. Uncontrolled intercurrent or chronic illness

10. Active hepatitis B or C with evidence of ongoing viral replication

11. Hyperthyroidism

12. Uncontrolled seizure disorder

13. Active coagulation disorder not controlled with medication

14. HIV positive

15. Congenital long QT syndrome or abnormal baseline QTc interval after Bazett's correction

16. Laboratory values outside of the acceptable range as given in protocol.