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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01861717
Recruitment Status : Terminated (Didn't enroll enough subjects)
First Posted : May 24, 2013
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
John Wayne Cancer Institute

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.


Condition or disease Intervention/treatment Phase
Acromegaly Drug: lanreotide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Actual Study Start Date : May 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Change in hypertension [ Time Frame: 3 months ]
    Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal

  3. 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

  4. 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:
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861717


Locations
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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
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Principal Investigator: Daniel F Kelly, MD John Wayne Cancer Institute
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Responsible Party: John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT01861717    
Other Study ID Numbers: KELD-ESS-0413
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
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:
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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
Antineoplastic Agents