Pilot Study of Oral 852A for Elimination of High-Grade Dysplasia in Barrett's Esophagus

This study has been terminated.
Sponsor:
Collaborator:
3M
Information provided by:
Rogers, B.H. Gerald, M.D.
ClinicalTrials.gov Identifier:
NCT00386594
First received: October 8, 2006
Last updated: January 20, 2009
Last verified: December 2006
  Purpose

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
Barrett Esophagus
Drug: 852A

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Rogers, B.H. Gerald, M.D.:

Primary Outcome Measures:
  • Elimination of high-grade dysplasia in Barrett's esophagus [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: October 2006
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386594

Locations
United States, Illinois
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
B. H. Gerald Rogers, M. D.
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Rogers, B.H. Gerald, M.D.
3M
Investigators
Principal Investigator: B. H. Gerald Rogers, M. D. Clinical Professor, University of Chicago School of Medicine. Attending Physician, Weiss Memorial Hospital, Chicago, Illinois
  More Information

No publications provided

Responsible Party: B. H. Gerald Rogers, M.D., Weiss Memorial Hospital, Chicago, Illinois
ClinicalTrials.gov Identifier: NCT00386594     History of Changes
Other Study ID Numbers: 100606
Study First Received: October 8, 2006
Last Updated: January 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Rogers, B.H. Gerald, M.D.:
Barrett Esophagus
High grade dysplasia
Carcinoma in situ
825A

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014