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

Information source: John Wayne Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acromegaly

Intervention: lanreotide (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: John Wayne Cancer Institute

Overall contact:
Daniel F Kelly, MD, Phone: 310.582.7450, Email: kellyd@jwci.org

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.

Clinical Details

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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Early remission of acromegaly

Secondary outcome:

Change in cardiac function

Change in hypertension

Change in respiratory function

Change in Quality of Life

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Daniel F Kelly, MD, Phone: 310.582.7450, Email: kellyd@jwci.org

Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System, Santa Monica, California 90404, United States; Recruiting
Daniel F Kelly, MD, Principal Investigator
Garni Barkhoudarian, MD, Sub-Investigator
Pejman Cohan, MD, Sub-Investigator
Niloufar Ilani, MD, Sub-Investigator
Gilbert Kuhn, MD, Sub-Investigator
Nicole Weinberg, MD, Sub-Investigator
Additional Information

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

Starting date: May 2013
Last updated: January 2, 2015

Page last updated: August 23, 2015

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