Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

This study is currently recruiting participants.
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00083512
First received: May 25, 2004
Last updated: March 14, 2014
Last verified: November 2013
  Purpose

This study will collect blood and urine samples from patients undergoing radiation therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this treatment on blood cells and certain proteins. The information from this study may help scientists develop new tests to measure radiation exposure and find new ways to treat cancer with radiation, and help determine which kinds of patients or tumors respond better to radiation therapy. Two proteins of particular interest in this study and which may be involved in the recurrence of cancer are VEGF (vascular endothelial growth factor) and MMPs (matrix metalloproteinases).

Patients 18 years of age and older with glioblastoma multiforme who are receiving or will receive radiation therapy as part of their medical treatment may be eligible for this study. Candidates are screened with a history and physical examination, blood tests, and magnetic resonance imaging (MRI) of the brain.

Participants will have blood and urine samples collected before, during and after completion of their radiation treatment. Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle n a vein. Additional samples may be requested at different times during treatment and in the 3-year follow-up period.


Condition
Glioblastoma

Study Type: Observational
Official Title: Urinary and Serum VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 100
Study Start Date: May 2004
Detailed Description:

BACKGROUND

  • Preliminary data generated from our pilot protocol 02-C-0064 suggests that the urinary VEGF and MMP level at the one month follow-up time point compared to the last on-treatment time point collection may be predictive of tumor recurrence at one year (l).
  • Note that this preliminary study included patients with all histologies.
  • In an on ongoing effort to validate our results with a larger more homogeneous patient cohort we propose to prospectively study patients undergoing radiotherapy for GBM.

OBJECTIVES

-We will determine the whether VEGF and MMP level measurements aide in predicting tumor recurrence at 1 year.

ELIGIBILITY

-Patients seen in the radiation oncology clinic will be asked to provide samples of blood and urine before, during and after their radiation treatment.

DESIGN

  • This protocol-provides a means of acquiring blood and urine samples from patients receiving radiation therapy for Glioblastoma multiforme (GBM).
  • Patients will be stratified according to their Radiation Therapy Oncology Group (RTOG) recursive partitioning prognostic subgroups, which includes patient age, KPS, extent of resection and neurological function.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Age greater than or equal to 18 years

Histologically confirmed supratentorial Glioblastoma multiforme

Karnofsky performance greater than 60

Patient must be a candidate for radiotherapy

EXCLUSION CRITERIA:

Inability to provide informed consent

Patients who have had prior radiotherapy to the brain

Patients with other cancers excluding nonmelanomatous skin cancers or carcinoma in situ

Gliadel wafer placement at the time of surgery

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083512

Contacts
Contact: Sharon L Smith, R.N. (301) 451-8905 smiths@mail.nih.gov
Contact: Kevin A Camphausen, M.D. (301) 496-5457 camphauk@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Kevin A Camphausen, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00083512     History of Changes
Obsolete Identifiers: NCT00087308
Other Study ID Numbers: 040200, 04-C-0200
Study First Received: May 25, 2004
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Blood
Urine
GBM
Radiation
Glioblastoma Multiforme

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on April 17, 2014