Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Nov 3, 1999

Keywords

ClinConnect Summary

Heretofore morbidity and mortality in Zollinger-Ellison syndrome were caused by severe ulcer disease. The advent of specific drugs to cure ulcer disease now extends life until metastases from the non-B-islet cell tumor or other events cause death. Patients with metastatic gastrinoma that is not surgically resectable and that has increased in size over a 4-6 month period prior to the study will be treated with interferon-alpha, 5 million international units/day. The drug will be administered subcutaneously by the patient. Tumor response and side effects will be monitored. Patients will recei...

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• Subjects selected for this study will be patients with Zollinger-Ellison syndrome who are being evaluated under the protocol entitled "Diagnostic evaluation of patients with suspected abnormalities of gastric secretion" (80-DK-123). To be entered into the study a patient must meet each of 3 criteria:
• • 1. histologically proven gastrinoma;
• • 2. evidence of metastatic tumor by one or more of angiography, ultrasound, computerized axial tomography, bone scan or octreoscan;
• • 3. progression of tumor size during the preceding 6 months as assessed by repeated imaging studies.
• • EXCLUSION CRITERIA
• For treatment with interferon-(alpha):
• • 1. Congestive heart failure
• • 2. Proteinuria, 3 + or greater
• • 3. Creatinine clearance less than 30 ml/min
• • 4. Platelet count less than 30 x 10(9)/1
• • 5. White blood count less than 4 x 10(9)/1
• • 6. Bilirubin greater than 3 mg/dl
• • 7. Positive test for HIV antibody
• • 8. Pregnancy
• For treatment with octreotide:
• • 1. Presence of cholelithiases