DRUG
lanreotide
Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses
A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
Status
Terminated
Phase
Phase 4
Enrollment
4
Locations
1
Results
Posted
Publications
0
Study summary
What the protocol is testing.
If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth hormone) the treatment is to have it surgically removed. This study has two phases. The first phase provides medical treatment with a drug that will be provided for 3 months before surgery to see if complications of surgery are reduced and to see whether or not remission improves following surgery if you have this medical treatment. The drug administered is approved by the FDA for long-term treatment of acromegaly. It is not routinely administered before surgery, and is therefore experimental as used in this way. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit. The second phase of this study is from 3 months until 12 months after surgery and is only for people who do not go into remission after the operation. This phase assesses the possible remission of acromegaly after resuming the drug treatment for an additional 3 to 9 months. The drug will be prescribed by your physician as part of your regular medical care and will not be included as part of the study. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit. The study lasts approximately 16 months - 3 month before surgery and 12 months after surgery.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
May 24, 2013
Study start
May 2013
Primary completion
Jan 2016
Study completion
Jan 2016
Results posted
Sep 30, 2021
Registry updated
Sep 30, 2021
Outcomes
What the study measures.
Primary outcomes
Early Remission of Acromegaly
Time frame · 3 months post-op
Early remission status after a 12 week course of pre-operative Somatuline Depot and 3 months after endonasal endoscopic surgery. Remission status will be based on age-adjusted Insulin Glucose Factor 1 (IGF-1) levels and oral glucose tolerance test.
Secondary outcomes
Change in Cardiac Function
Time frame · 3 month post-op
Changes in cardiac function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal.
Change in Hypertension
Time frame · 3 months
Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Change in Respiratory Function
Time frame · 12 weeks and 3 months
Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Change in Quality of Life
Time frame · 3 months
Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * age 18 - 75 * elevated serum Insulin-like growth factor-1 (IGF-1) level above age- and sex-based normal values and failure of growth hormone(GH) suppression to \< 1.0 ng/ml after a 75 gm oral glucose tolerance test (OGTT) American Association of Clinical Endocrinolgists (AACE) Acromegaly Clinical Guidelines 2004 * visible pituitary adenoma (microadenoma or macroadenoma) on high quality pituitary MRI without and with gadolinium * prior treatments for acromegaly with surgery, somatostatin analogs or pegvisomant are acceptable if these therapies have been discontinued for at least 3 months prior to study entry Exclusion Criteria: * Age \< 18 or \> 75 years * acromegalic patients currently on a lanreotide or octreotide preparation or on pegvisomant * patients who have received prior radiotherapy or radiosurgery * patients with adenoma-related visual acuity or visual field deficit from optic nerve and/or chiasm compression or severe optic nerve/chiasm compression in the setting of normal visual fields and acuity * patients with pituitary apoplexy defined as recent tumor hemorrhage and/or infarction on MRI with associated symptoms of new onset visual loss, diplopia and/or adrenal insufficiency
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System
Santa Monica, California, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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