Back to resultsA Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
Primary Purpose
Acromegaly
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lanreotide
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring excess growth hormone, excess GH, gigantism, pituitary tumor, pituitary adenoma, growth hormone tumor, GH secreting adenoma, Somatuline, lanreotide
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
Sites / Locations
- Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Somatuline Depot Subcutaneous (SC)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Cardiac Function
Changes in cardiac function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal.
Change in Hypertension
Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Change in Respiratory Function
Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Change in Quality of Life
Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Full Information
NCT ID
NCT01861717
First Posted
May 15, 2013
Last Updated
September 2, 2021
Sponsor
Saint John's Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01861717
Brief Title
A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Didn't enroll enough subjects
Study Start Date
May 2013 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint John's Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
excess growth hormone, excess GH, gigantism, pituitary tumor, pituitary adenoma, growth hormone tumor, GH secreting adenoma, Somatuline, lanreotide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Somatuline Depot Subcutaneous (SC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lanreotide
Other Intervention Name(s)
Somatuline Depot SC
Intervention Description
Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses
Primary Outcome Measure Information:
Title
Early Remission of Acromegaly
Description
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.
Time Frame
3 months post-op
Secondary Outcome Measure Information:
Title
Change in Cardiac Function
Description
Changes in cardiac function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal.
Time Frame
3 month post-op
Title
Change in Hypertension
Description
Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Time Frame
3 months
Title
Change in Respiratory Function
Description
Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Time Frame
12 weeks and 3 months
Title
Change in Quality of Life
Description
Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Remission Status 1 Year After Surgery
Description
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.
Time Frame
12 months post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel F Kelly, MD
Organizational Affiliation
Saint John's Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://newstjohns.org/braintumorcenter.aspx
Description
Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute at Saint John's Health Center
Learn more about this trial
A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
We'll reach out to this number within 24 hrs