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

Acromegaly Clinical Trial

Official title:

A Pilot Study of Pre- and Post-operative Somatuline Depot Therapy in Acromegalic Patients Treated by Endonasal Endoscopic Surgery: Impact on Early Remission Rates and Perioperative Morbidity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01861717
• Other study ID #: KELD-ESS-0413
• Status: Terminated
• Phase: Phase 4
• Start date: May 2013
• Est. completion date: January 2016

Study information

• Verified date: September 2021
• Source: John Wayne Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• lanreotide
Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses

Locations

Country	Name	City	State
United States	Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
John Wayne Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Remission Status 1 Year After Surgery	Remission status one year after surgery and time to achieve remission in patients who did not achieve remission after endonasal endoscopic surgery and who had resumption of Somatuline Depot therapy 3 months after surgery.	12 months post-op
Primary	Early Remission of Acromegaly	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.	3 months post-op
Secondary	Change in Cardiac Function	Changes in cardiac function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal.	3 month post-op
Secondary	Change in Hypertension	Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal	3 months
Secondary	Change in Respiratory Function	Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal	12 weeks and 3 months
Secondary	Change in Quality of Life	Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal	3 months

External Links

•   Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute at Saint John's Health Center