Status:
TERMINATED
Pilot Study of Oral 852A for Elimination of High-Grade Dysplasia in Barrett's Esophagus
Lead Sponsor:
Rogers, B.H. Gerald, M.D.
Collaborating Sponsors:
3M
Conditions:
Barrett Esophagus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 unt...
Detailed Description
This study is to determine if a locally applied immune response modifier will eliminate high grade dysplasia in Barrett's esophagus. Barrett's esophagus is a premalignant condition caused by chronic r...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion criteria.
- 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
- Hyperthyroidism
- Uncontrolled seizure disorder
- Active coagulation disorder not controlled with medication
- HIV positive
- Congenital long QT syndrome or abnormal baseline QTc interval after Bazett's correction
- Laboratory values outside of the acceptable range as given in protocol.
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00386594
Start Date
October 1 2006
End Date
October 1 2012
Last Update
January 21 2009
Active Locations (2)
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1
B. H. Gerald Rogers, M. D.
Chicago, Illinois, United States, 60611
2
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640