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Evaluation of Treatment With Interferon, Octreotide, or Their Combination in Patients With Zollinger-Ellison Syndrome and Progressive Metastatic Non-B Islet Cell Neoplasm


Phase 2
18 Years
N/A
Not Enrolling
Both
Islet Cell Adenoma, Zollinger Ellison Syndrome

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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 PikeBethesda, Maryland  20892