Islet Cell AdenomaPhase 2NCT00001228
Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer
A Phase 2 study testing Interferon in people with Islet Cell Adenoma and Zollinger Ellison Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Islet Cell Adenoma, Zollinger Ellison Syndrome
- What is being tested?
- Interferon
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 1988to 6 Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- Bilirubin greater than 3 mg/dl
- Positive test for HIV antibody
- Pregnancy
- For treatment with octreotide:
- 1. Presence of cholelithiases
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Islet Cell Adenoma, Zollinger Ellison Syndrome
- Being tested
- Interferon
- Keywords
- Interferon, Zollinger-Ellison Syndrome
- Medical subject headings
- Adenoma, Islet Cell, Zollinger-Ellison Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterferonDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start25 Oct 1988
- Study completion6 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Islet Cell AdenomaStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 50 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001228
- Sponsor's protocol ID
- 880194
- Other IDs
- 88-DK-0194
- Status last verified
- 6 Sep 2007
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Shepherd JJ, Senator GB. Regression of liver metastases in patient with gastrin-secreting tumour treated with SMS 201-995. Lancet. 1986 Sep 6;2(8506):574. doi: 10.1016/s0140-6736(86)90139-x. No abstract available.
PubMed 2875303
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00001228
- Acronym / sponsor ID
- 880194
- Conditions
- Islet Cell Adenoma, Zollinger Ellison Syndrome
- Keywords
- Interferon, Zollinger-Ellison Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 25 Oct 1988
- Study completion
- 6 Sep 2007
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 2875303Shepherd JJ, Senator GB. Regression of liver metastases in patient with gastrin-secreting tumour treated with SMS 201-995. Lancet. 1986 Sep 6;2(8506):574. doi: 10.1016/s0140-6736(86)90139-x. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interferon in people with Islet Cell Adenoma and Zollinger Ellison Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.