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Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer Clinical research trials and Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer. Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer  Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer
Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer
For Condition: Islet Cell Adenoma,Zollinger Ellison Syndrome
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details: 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, either alone or with the long-acting somatostatin analogue, octreotide. The alpha-interferon will be administered subcutaneously by the patient and the octreotide either by the patient or their physician. 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:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 50
Location and Contact Information:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 880194; 88-DK-0194
Study Start Date: October 25, 1988
Record last reviewed: October 20, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001228
Other Zollinger Ellison Syndrome Studies:
1. The Use of Oral Omeprazole and Intravenous Pantoprazole in Patients with Hypersecretion of Gastric Acid
2. Treatment of Zollinger-Ellison Syndrome
3. Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer
4. Evaluating Patients with Abnormal Levels of Gastric Acid
Related Studies:
Other Zollinger Ellison Syndrome Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer
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