Search / Trial NCT00001228

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

Apply for Trial

Trial Information

Current as of July 14, 2024

Completed

Keywords

Interferon Zollinger Ellison Syndrome

Description

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:
  • histologically proven gastrinoma;
  • evidence of metastatic tumor by one or more of angiography, ultrasound, computerized axial tomography, bone scan or octreoscan;
  • progression of tumor size during the preceding 6 months as assessed by repeated imaging studies.
  • EXCLUSION CRITERIA
  • For treatment with interferon-(alpha):
  • Congestive heart failure
  • Proteinuria, 3 + or greater
  • Creatinine clearance less than 30 ml/min
  • Platelet count less than 30 x 10(9)/1
  • White blood count less than 4 x 10(9)/1
  • Bilirubin greater than 3 mg/dl
  • Positive test for HIV antibody
  • Pregnancy
  • For treatment with octreotide:
  • 1. Presence of cholelithiases

Attachments

readout_NCT00001228_2024-07-14.pdf

4.5 MB

NCT00001228_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0