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
  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: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Effect of Monoclonal Vascular Endothelial Growth Factor (VEGF) Antibody (Bevacizumab) on Pituitary Function

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: 6 weeks ] [ Designated as safety issue: No ]
    Patients will have their blood drawn before their first Bevacizumab infusion and then again 6 weeks later.


Biospecimen Retention:   Samples Without DNA

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


Enrollment: 6
Study Start Date: September 2009
Study Completion Date: January 2012
Primary Completion Date: September 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973557

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

Publications:
Responsible Party: William Gellepis, Research Administrator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00973557     History of Changes
Other Study ID Numbers: Pro00019830
Study First Received: September 8, 2009
Last Updated: February 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
bevacizumab

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Glioblastoma
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Mitogens
Endothelial Growth Factors

ClinicalTrials.gov processed this record on July 22, 2014