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The Effect of Monoclonal Vascular Endothelial Growth Factor (VEGF) Antibody (Bevacizumab) on Pituitary Function
This study is currently recruiting participants.
Verified by Cedars-Sinai Medical Center, September 2009
First Received: September 8, 2009   No Changes Posted
Sponsor: Cedars-Sinai Medical Center
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00973557
  Purpose

The purpose of this research is to determine whether the drug, Bevacizumab (a monoclonal anti VEGF-A antibody), which is approved to treat patients with metastatic colon cancer induces hyperprolactinemia (increased prolactin secretion) in humans with intact pituitary function. Past studies have shown Bevacizumab to shrink tumor size and also increase prolactin levels. The mechanism of the hyperprolactinemia might be inhibition of pituitary portal vein transport, suggesting that Bevacizumab induces prolactin secretion from normal lactotrophs in the pituitary gland.

Patients who have been treated with Bevacizumab for at least one month will be recruited to participate.

The subjects who are being treated with Bevacizumab by Dr. Stephen Wolin (a sub-investigator) will be screened by him for study eligibility. Dr. Wolin will approach eligible patients with all the information and background of the study and see if they have an interest in being consented.

If consented, there will be 2 blood draws for the research that is not part of their standard care in which 10 ml of blood is collected and prolactin, growth hormone, IGF-I, TSH, thyroxine, ACTH, and cortisol will be measured. One 5ml blood draw will occur before the administration of Bevacizumab and the second 5 ml blood draw will occur after the administration of the Bevacizumab. The investigators will then review the laboratory results. The blood tests are of the hormones of the pituitary gland to test pituitary function and see if there are any abnormalities with the secretions of the gland. Pituitary function abnormalities and hyperprolactinemia are diagnosed by looking at hormone levels in the blood and comparing them to the normal reference ranges.

This study will only involve 10 subjects and will be conducted entirely at Cedars-Sinai Medical Center.


Condition
Colorectal Cancer
Lung Cancer
Breast Cancer
Glioblastoma

Study Type: Observational
Study Design: Cohort, Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • To determine whether the drug, Bevacizumab (a monoclonal anti VEGF-A antibody), which is approved to treat patients with metastatic colon cancer induces hyperprolactinemia (increased prolactin secretion) in humans with intact pituitary function. [ Time Frame: 1 visit for bloodraw ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

10 ml of whole blood will be collected to measure prolactin, growth hormone, IGF-I, TSH, thyroxine, ACTH, and cortisol levels


Estimated Enrollment: 10
Study Start Date: September 2009
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Taking Bevacizumab
Patients who are currently being treated for cancer by the drug Bevacizumab.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have cancer and have been treated with the drug Bevacizumab for at least one month.

Criteria

Inclusion Criteria:

  • Patients with colorectal cancer, lung cancer, breast cancer, and glioblastoma patients that have been treated with Bevacizumab for at least 1 month
  • Adults (18 years of age or older)

Exclusion Criteria:

  • Patients who are taking medications known to affect serum prolactin levels
  • Patients who are pregnant
  • Patients who have pituitary disease
  • Minors (Under the age of 18)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973557

Contacts
Contact: Hidenori Fukuoka, MD fukuokah@cshs.org
Contact: Billy Gellepis 310-423-3395 gellepisw@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Shlomo Melmed, MD            
Sub-Investigator: Edward Wolin, MD            
Sub-Investigator: Hidenori Fukuoka, MD            
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Shlomo Melmed, MD Cedars-Sinai Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Cedars-Sinai Medical Center ( Shlomo Melmed/Senior Vice President of Academic Affairs )
Study ID Numbers: Pro00019830
Study First Received: September 8, 2009
Last Updated: September 8, 2009
ClinicalTrials.gov Identifier: NCT00973557     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
bevacizumab

Additional relevant MeSH terms:
Thoracic Neoplasms
Glioblastoma
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Neoplasms, Nerve Tissue
Bevacizumab
Rectal Diseases
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Growth Inhibitors
Angiogenesis Modulating Agents
Glioma
Breast Diseases
Respiratory Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Skin Diseases
Astrocytoma
Growth Substances
Breast Neoplasms
Endothelial Growth Factors
Intestinal Diseases
Angiogenesis Inhibitors
Pharmacologic Actions
Intestinal Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010