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The Effect of Monoclonal Vascular Endothelial Growth Factor (VEGF) Antibody (Bevacizumab) on Pituitary Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Gellepis, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00973557
First received: September 8, 2009
Last updated: February 6, 2012
Last verified: February 2012
History of Changes

September 8, 2009
February 6, 2012
September 2009
September 2011   (final data collection date for primary outcome measure)
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: 6 weeks ] [ Designated as safety issue: No ]
Patients will have their blood drawn before their first Bevacizumab infusion and then again 6 weeks later.
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 ]
Complete list of historical versions of study NCT00973557 on ClinicalTrials.gov Archive Site
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The Effect of Monoclonal Vascular Endothelial Growth Factor (VEGF) Antibody (Bevacizumab) on Pituitary Function
The Effect of Monoclonal Vascular Endothelial Growth Factor (VEGF) Antibody (Bevacizumab) on Pituitary Function

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

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

Patients who have cancer and have been treated with the drug Bevacizumab for at least one month.
  • Colorectal Cancer
  • Lung Cancer
  • Breast Cancer
  • Glioblastoma
Not Provided
Taking Bevacizumab
Patients who are currently being treated for cancer by the drug Bevacizumab.
Korsisaari N, Ross J, Wu X, Kowanetz M, Pal N, Hall L, Eastham-Anderson J, Forrest WF, Van Bruggen N, Peale FV, Ferrara N. Blocking vascular endothelial growth factor-A inhibits the growth of pituitary adenomas and lowers serum prolactin level in a mouse model of multiple endocrine neoplasia type 1. Clin Cancer Res. 2008 Jan 1;14(1):249-58.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
January 2012
September 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00973557
Pro00019830
No
William Gellepis, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Not Provided
Principal Investigator: Shlomo Melmed, MD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP