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

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ClinicalTrials.gov Identifier: NCT00973557
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : February 7, 2012
Sponsor:
Information provided by (Responsible Party):
William Gellepis, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date September 8, 2009
First Posted Date September 9, 2009
Last Update Posted Date February 7, 2012
Study Start Date September 2009
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 16, 2010)
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 ]
Patients will have their blood drawn before their first Bevacizumab infusion and then again 6 weeks later.
Original Primary Outcome Measures
 (submitted: September 8, 2009)
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 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of Monoclonal Vascular Endothelial Growth Factor (VEGF) Antibody (Bevacizumab) on Pituitary Function
Official Title The Effect of Monoclonal Vascular Endothelial Growth Factor (VEGF) Antibody (Bevacizumab) on Pituitary Function
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen 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
Sampling Method Non-Probability Sample
Study Population Patients who have cancer and have been treated with the drug Bevacizumab for at least one month.
Condition
  • Colorectal Cancer
  • Lung Cancer
  • Breast Cancer
  • Glioblastoma
Intervention Not Provided
Study Groups/Cohorts Taking Bevacizumab
Patients who are currently being treated for cancer by the drug Bevacizumab.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 6, 2012)
6
Original Estimated Enrollment
 (submitted: September 8, 2009)
10
Actual Study Completion Date January 2012
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00973557
Other Study ID Numbers Pro00019830
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party William Gellepis, Cedars-Sinai Medical Center
Study Sponsor Cedars-Sinai Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Shlomo Melmed, MD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date February 2012