Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001228
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-09-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 unitsday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 88-DK-0194 | None | None | None |