A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.

Phase 4

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Somatuline Depot Subcutaneous (SC)	lanreotide	Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.

Primary Outcome Measures

Name	Time	Method
Early Remission of Acromegaly	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 Outcome Measures

Name	Time	Method
Change in Cardiac Function	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	3 months	Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Change in Quality of Life	3 months	Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Change in Respiratory Function	12 weeks and 3 months	Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal

Locations (1): Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System
🇺🇸
Santa Monica, California, United States