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

NCT01861717 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: KELD-ESS-0413
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

excess growth hormone; excess GH; gigantism; pituitary tumor; pituitary adenoma; growth hormone tumor; GH secreting adenoma; Somatuline; lanreotide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Cardiac Function

  3 month post-op

• Change in Hypertension

  3 months

• Change in Respiratory Function

  12 weeks and 3 months

• Change in Quality of Life

  3 months

Other Outcomes (1)

• Remission Status 1 Year After Surgery

  12 months post-op

Study Arms (1)

Somatuline Depot Subcutaneous (SC)

EXPERIMENTAL

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.

Drug: lanreotide

Interventions

lanreotide DRUG

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

Also known as: Somatuline Depot SC

Somatuline Depot Subcutaneous (SC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint John's Cancer Institute: lead

Study Sites (1)

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

Santa Monica, California, 90404, United States

Location

Related Links

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

MeSH Terms

Conditions

Acromegaly; Gigantism; Pituitary Neoplasms

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Bone Diseases, Developmental; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms

Results Point of Contact

• Title: Dr. Daniel Kelly
• Organization: JOHN WAYNE CANCER INSTITUTE

Daniel.Kelly2@providence.org

310-582-7450

Study Officials

• Daniel F Kelly, MD

  Saint John's Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 24, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: September 30, 2021
• Results First Posted: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)