Evaluation of Treatment With Interferon, Octreotide, or Their Combination in Patients With Zollinger-Ellison Syndrome and Progressive Metastatic Non-B Islet Cell Neoplasm
18 Years
N/A
Both
Islet Cell Adenoma, Zollinger Ellison Syndrome
Trial Information
Evaluation of Treatment With Interferon, Octreotide, or Their Combination in Patients With Zollinger-Ellison Syndrome and Progressive Metastatic Non-B Islet Cell Neoplasm
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 receive 6 months of
therapy and if there is reduction or stabilization of tumor masses, therapy will continue as
long as response is maintained.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Authority:
United States: Federal Government
Study ID:
880194
NCT ID:
NCT00001228
Start Date:
October 1988
Completion Date:
September 2007
Related Keywords:
- Islet Cell Adenoma
- Zollinger Ellison Syndrome
- Interferon
- Zollinger-Ellison Syndrome
- Adenoma
- Adenoma, Islet Cell
- Zollinger-Ellison Syndrome
- Gastrinoma
Name | Location |
|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
