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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973557
• Other study ID #: Pro00019830
• Status: Completed
• Phase: N/A
• First received: September 8, 2009
• Last updated: February 6, 2012
• Start date: September 2009
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Glioblastoma
• Lung Cancer

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1158/1078-0432.CCR-07-1552. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Patients will have their blood drawn before their first Bevacizumab infusion and then again 6 weeks later.	6 weeks	No