Zollinger Ellison Syndrome clinical trials

YF476 in Patients With Type II Gastric Carcinoids Associated With Zollinger-Ellison Syndrome

Background: - Zollinger-Ellison syndrome (ZES) is a rare condition in which one or more tumors (gastrinomas), usually in the small intestine or pancreas, produce high levels of the hormone gastrin. High levels of gastrin can cause several problems: (1) excessive growth of stomach cells; (2) excessive production of stomach acid, which can cause stomach or intestinal ulcers; and (3) growth of an unusual type of stomach tumor called a type II gastric (i.e., stomach) carcinoid. Patients with ZES suffer mainly from the effects of severe ulcer disease, but gastrinomas and gastric carcinoids both have the potential to spread throughout the body. Gastric surgery is the usual treatment for problematic carcinoids. YF476, an experimental medication, may block the effects of gastrin, which may reduce the need for surgery as well as provide better control of stomach acid in patients with ZES. Researchers are interested in studying YF476 in individuals with ZES who also have or may develop type II gastric carcinoids. Objectives: - To evaluate the safety and effectiveness of YF476 in reducing the size, number, or significance of type II gastric carcinoids or their precancerous cells. - To study the effects of YF476 on stomach acid production. Eligibility: - Individuals at least 18 years of age who have been diagnosed with Zollinger-Ellison syndrome and type II gastric carcinoids or their precancerous cells. Design: - This study will involve a screening visit and five study visits. - Participants will be screened with a physical examination and medical history, as well as blood tests. - At the first study visit, participants will have an initial measurement of stomach acid production (gastric acid analysis) and an upper endoscopy to collect biopsies of esophagus, stomach, and small intestine tissue. Participants will receive YF476 to take by mouth once per day with food, and will be asked to keep a diary of medication doses, changes in symptoms, and any possible new symptoms or problems. - After 3 weeks, participants will have another study visit with a physical examination, blood and urine tests, and questions about current condition and any side effects. - After another 3 weeks (6 weeks after starting YF476), participants will have another gastric acid analysis and an upper endoscopy with biopsies. Participants may be eligible to receive a higher dose of YF476 if the endoscopy and biopsies show no significant change (decreased size and/or number of carcinoids or precancerous cells). If the stomach is completely normal at this visit on endoscopy and biopsy, participants will stop taking the study drug. - After another 6 weeks (12 weeks after starting YF476), participants will have another physical examination, blood and urine tests, and an upper endoscopy with biopsies. YF476 will be stopped. Participants who show improvement after treatment will have a final followup visit. Participants who do not show improvement will not have the followup visit, but may be asked to return for additional clinic visits to check for side effects from YF476. - The final visit will be a followup visit 12 weeks after the end of treatment with YF476. Participants who responded to YF476 will have blood tests and an upper endoscopy with biopsies.