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Sponsors and Collaborators: |
Rogers, B.H. Gerald, M.D. 3M |
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Information provided by: | Rogers, B.H. Gerald, M.D. |
ClinicalTrials.gov Identifier: | NCT00386594 |
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.
Condition | Intervention |
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Barrett Esophagus |
Drug: 852A |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Estimated Enrollment: | 10 |
Study Start Date: | October 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria.
Contact: B. H. Gerald Rogers, M.D. | 312-828-9747 | bhgrogers@pol.net |
Contact: May B. Rogers, R.N. | 312-828-9747 |
United States, Illinois | |
Weiss Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60640 | |
Contact: B. H. Gerald Rogers, M.D. 312-828-9747 bhgrogers@pol.net | |
Contact: May B. Rogers, R.N. 312-828-9747 | |
Principal Investigator: B. H. Gerald Rogers, M. D. | |
B. H. Gerald Rogers, M. D. | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: B H Gerald Rogers, M.D. 312-828-9747 bhgrogers@pol.net | |
Contact: May B Rogers, R. N. 312-828-9747 | |
Principal Investigator: B H Gerald Rogers, M. D. |
Principal Investigator: | B. H. Gerald Rogers, M. D. | Clinical Professor, University of Chicago School of Medicine. Attending Physician, Weiss Memorial Hospital, Chicago, Illinois |
Study ID Numbers: | 100606 |
Study First Received: | October 8, 2006 |
Last Updated: | December 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00386594 |
Health Authority: | United States: Food and Drug Administration |
Barrett Esophagus High grade dysplasia Carcinoma in situ 825A |
Digestive System Diseases Digestive System Abnormalities Esophageal disorder Gastrointestinal Diseases Carcinoma in Situ |
Barrett Esophagus Esophageal Diseases Congenital Abnormalities Carcinoma |