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

This study has been completed.

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001228
  Purpose

This study will examine the safety and effectiveness of interferon-a and octreotide for the treatment of Zollinger-Ellison syndrome (gastrinoma) and advanced non-B islet cell cancer. Gastrinoma is a tumor produced by the pancreas that secretes the hormone gastrin, which in turn stimulates production of gastric juices that cause ulcers. Some of these tumors are malignant. Gastrinomas that have spread and cannot be surgically removed require drug treatment (chemotherapy). Current drug regimens, however, provide only temporary benefit and, in some cases, produce life-threatening side effects. In studies of patients with tumors similar to gastrinoma, the drugs octreotide and interferon-a, alone or in combination, showed some effect in stopping tumor growth and were better tolerated than chemotherapy. At least one-third of patients responded to treatment with either drug for at least 6 months; the two drugs given together may produce a better response than either one alone.

Patients currently enrolled in an NIH study of Zollinger-Ellison syndrome whose gastrinoma has spread from the original site and cannot be surgically removed may be eligible for this study.

Participants will be admitted to the NIH Clinical Center for blood and urine tests, electrocardiogram (EKG), chest X-ray and imaging studies (CT, ultrasound, MRI, octreoscan, and bone scan) before beginning treatment to evaluate the size and extent of tumors. Patients will then start interferon-a or octreotide, or both, given as injections under the skin. Treatment will continue for at least 6 months, unless side effects require stopping the drugs early. Patients whose tumors shrink or remain stable may continue treatment indefinitely. Those who do not respond to treatment will be taken off the study and offered standard chemotherapy.

Patients will be admitted to the hospital for the first day or two of therapy to be monitored for side effects and to learn how to self-inject the drugs to continue therapy at home. Both drugs are given [Note: how often? once a day, twice a day, weekly?] (Octreotide is also available in long-acting form, and patients who prefer may be given this drug once a month by the doctor.)

During the treatment period, patients will be seen by their personal physician every 2 weeks for the first month and once a month thereafter for a medical evaluation and check of adverse side effects of treatment. In addition, they will be admitted to the NIH Clinical Center once every 3 months for a medical evaluation and imaging studies, including CT, MRI, ultrasound, bone scan, and octreoscan, to assess the effect of treatment on tumor size.


Condition Intervention Phase
Islet Cell Adenoma
Zollinger Ellison Syndrome
Drug: Interferon
Phase II

MedlinePlus related topics:   Cancer   

Drug Information available for:   Interferon alfa-2b    Interferons    Octreotide    Octreotide acetate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Evaluation of Treatment With Interferon, Octreotide, or Their Combination in Patients With Zollinger-Ellison Syndrome and Progressive Metastatic Non-B Islet Cell Neoplasm

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   50
Study Start Date:   October 1988
Estimated Study Completion Date:   September 2007

Detailed 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 receive 6 months of therapy and if there is reduction or stabilization of tumor masses, therapy will continue as long as response is maintained.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001228

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators
  More Information


Publications:

Study ID Numbers:   880194, 88-DK-0194
First Received:   November 3, 1999
Last Updated:   September 7, 2007
ClinicalTrials.gov Identifier:   NCT00001228
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Interferon  
Zollinger-Ellison Syndrome  

Study placed in the following topic categories:
Gastrointestinal Diseases
Pancreatic Neoplasms
Octreotide
Stomach Diseases
Zollinger-Ellison Syndrome
Zollinger-Ellison syndrome
Peptic Ulcer
Endocrine Gland Neoplasms
Interferon-alpha
Digestive System Neoplasms
Carcinoma, Islet Cell
Ulcer
Interferons
Endocrine System Diseases
Adenoma, Islet Cell
Intestinal Diseases
Paraneoplastic Syndromes
Digestive System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Interferon Alfa-2a
Adenoma
Interferon Alfa-2b
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Disease
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Paraneoplastic Endocrine Syndromes
Neoplasms
Neoplasms by Site
Pathologic Processes
Syndrome
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on October 29, 2008




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