Therapeutic Intervention to Reverse Gastric Precancer
Katherine Garman
Summary
This study is designed to test the use of Pyrvinium vs placebo as a treatment for gastric intestinal metaplasia with features associated with increased risk of cancer. Response will be determined by assessing the extent and quality of the gastric intestinal metaplasia before and after treatment. A secondary aim will be to generate gastric organoids from patient-derived samples to test the effects of pyrvinium in vitro in patient-derived samples, and also to identify new drugs that may help reverse gastric intestinal metaplasia.
Description
The proposed study is an early Phase II Clinical Trial designed to generate additional data regarding safety and efficacy for the use of Pyrvinium, an FDA-approved drug no longer in active use. The study design includes enrollment in an observational cohort for a research-focused screening upper endoscopy to document the extent and type of gastric intestinal metaplasia in patients previously diagnosed with this condition using a standardized mapping protocol (as described below). This initial screening research endoscopy is needed as current clinical care is variable (due to lack of guidelines…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults (including men, women, and non-binary individuals) over age 18 with known GIM with at least one high-risk feature (extensive vs limited, incomplete or mixed-type GIM, family history of stomach cancer), * Ability to provide informed consent, * Evidence of prior but not active H. pylori infection Exclusion Criteria: * Active gastric cancer diagnosis, * High-risk of bleeding complications due to anticoagulants or underlying medical condition, * Pregnancy (which is a contraindication to non-emergent endoscopy due to anesthesia risks)
Interventions
- DrugPyrvinium
Pyrvinium (2 mg/kg) per day for 14 days
- DrugPlacebo
Placebo for 14 days
Location
- Duke HealthDurham, North Carolina