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

NCT ID: NCT01861717

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-01-31

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.

Conditions

Acromegaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Somatuline Depot Subcutaneous (SC)

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.

Group Type: EXPERIMENTAL

lanreotide

Intervention Type: DRUG

Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses

Interventions

lanreotide

Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses

Intervention Type: DRUG

Other Intervention Names

Somatuline Depot SC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint John's Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel F Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

Saint John's Cancer Institute

Locations

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

Santa Monica, California, United States

Countries

United States

Related Links

http://newstjohns.org/braintumorcenter.aspx

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

Other Identifiers

KELD-ESS-0413

Identifier Type: -

Identifier Source: org_study_id