NCT00386594

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 21, 2009

Status Verified

December 1, 2006

Enrollment Period

4 years

First QC Date

October 8, 2006

Last Update Submit

January 20, 2009

Conditions

Barrett Esophagus

Keywords

Barrett EsophagusHigh grade dysplasiaCarcinoma in situ825A

Outcome Measures

Primary Outcomes (1)

  • Elimination of high-grade dysplasia in Barrett's esophagus

    2 years

Interventions

852ADRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

B. H. Gerald Rogers, M. D.

Chicago, Illinois, 60611, United States

Location

Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

MeSH Terms

Conditions

Barrett EsophagusCarcinoma in Situ

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • B. H. Gerald Rogers, M. D.

    Clinical Professor, University of Chicago School of Medicine. Attending Physician, Weiss Memorial Hospital, Chicago, Illinois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

October 8, 2006

First Posted

October 11, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2010

Study Completion

October 1, 2012

Last Updated

January 21, 2009

Record last verified: 2006-12

Locations

US(2)