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Trial record 4 of 4 for:
"Gigantism"
A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
This study has been completed.
Sponsor:
John Wayne Cancer Institute
Information provided by (Responsible Party):
John Wayne Cancer Institute
ClinicalTrials.gov Identifier:
NCT01861717
First received: May 15, 2013
Last updated: February 3, 2017
Last verified: February 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Acromegaly | Drug: lanreotide | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by John Wayne Cancer Institute:
Primary Outcome Measures:
- Early remission of acromegaly [ Time Frame: 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:
- Change in cardiac function [ Time Frame: 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 [ Time Frame: 3 months ]Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
- Change in respiratory function [ Time Frame: 12 weeks and 3 months ]Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
- Change in Quality of Life [ Time Frame: 3 months ]Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Other Outcome Measures:
- Remission status 1 year after surgery [ Time Frame: 12 months post-op ]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.
| Enrollment: | 4 |
| Actual Study Start Date: | May 2013 |
| Study Completion Date: | January 2016 |
| Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Somatuline Depot 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.
|
Drug: lanreotide
Somatuline Depot 90 mg deep subcutaneous injecton every 4 weeks X 3 doses
Other Name: Somatuline Depot SC
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age 18 - 75
- elevated serum 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01861717
Please refer to this study by its ClinicalTrials.gov identifier: NCT01861717
Locations
| United States, California | |
| Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System | |
| Santa Monica, California, United States, 90404 | |
Sponsors and Collaborators
John Wayne Cancer Institute
Investigators
| Principal Investigator: | Daniel F Kelly, MD | John Wayne Cancer Institute |
More Information
Additional Information:
| Responsible Party: | John Wayne Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01861717 History of Changes |
| Other Study ID Numbers: |
KELD-ESS-0413 |
| Study First Received: | May 15, 2013 |
| Last Updated: | February 3, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by John Wayne Cancer Institute:
|
excess growth hormone excess GH gigantism pituitary tumor pituitary adenoma |
growth hormone tumor GH secreting adenoma Somatuline lanreotide |
Additional relevant MeSH terms:
|
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Endocrine System Diseases Lanreotide Angiopeptin Somatostatin Antineoplastic Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 14, 2017