Tissue Biomarker for Pegvisomant Action

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Acromegaly is a disease of the pituitary gland that involves overproduction of growth hormone. Pegvisomant works by blocking binding of GH to receptors found in tissues throughout the body. Human studies have evaluated pegvisomant action by measuring reduction of IGF-I levels in the blood. However, no studies have evaluated the effects of blocking GH receptors in tissues. In this study, we will study tissue biomarkers for pegvisomant action in GH and IGF-I dependent signaling pathways in colon tissue of patients with acromegaly treated with pegvisomant.

Condition or disease	Intervention/treatment	Phase
Acromegaly	Drug: Pegvisomant	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	8 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Tissue Biomarker for Pegvisomant Action
Study Start Date :	November 2010
Actual Primary Completion Date :	March 2013
Actual Study Completion Date :	December 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Pegvisomant	Drug: Pegvisomant; Pegvisomant used as indicated; Other Name: Somavert

Outcome Measures

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Primary Outcome Measures :

1. Effect of Pegvisomant on Colon Tissue p53 Expression [ Time Frame: 8 weeks ]
   Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Diagnosis of acromegaly established on the basis of symptoms and signs at presentation, evidence of a pituitary adenoma on MRI, elevated serum concentrations of IGF1 (>1.3 X ULN), and inadequate GH suppression (>0.4 ng/mL) following OGTT
• Candidates to receive pegvisomant therapy following pituitary adenoma surgery, or intolerant of other medical treatments or had not undergone previous therapy
• Normal LFTs before treatment
• Dynamic testing of the pituitary axis and, if applicable, appropriate hormone replacement

Exclusion Criteria:

• Treatment with a long-acting SRL within 12 weeks before enrollment
• Presence of a macroadenoma with visual field defects as a result of chiasmatic compression
• Clinically significant hepatic abnormalities and/or AST or ALT >3 X ULN on screening
• Known hypersensitivity to any of the test materials or related compounds
• History of, or known current, problems with alcohol or drug abuse
• Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

Principal Investigator:	Shlomo Melmed, MD	Cedars-Sinai Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Chesnokova V, Zonis S, Zhou C, Recouvreux MV, Ben-Shlomo A, Araki T, Barrett R, Workman M, Wawrowsky K, Ljubimov VA, Uhart M, Melmed S. Growth hormone is permissive for neoplastic colon growth. Proc Natl Acad Sci U S A. 2016 Jun 7;113(23):E3250-9. doi: 10.1073/pnas.1600561113. Epub 2016 May 25. Erratum in: Proc Natl Acad Sci U S A. 2016 Aug 30;113(35):E5251.

Responsible Party:	Shlomo Melmed, MD, Executive Vice President, Academic Affairs, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT01261000 History of Changes
Other Study ID Numbers:	Pro23051; WS921563 ( Other Grant/Funding Number: Pfizer )
First Posted:	December 16, 2010
Results First Posted:	August 22, 2017
Last Update Posted:	August 22, 2017
Last Verified:	July 2017

Keywords provided by Shlomo Melmed, MD, Cedars-Sinai Medical Center:

Acromegaly

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