Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
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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 Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein. Additional samples may be requested at different times during treatment and in the 3-year follow-up period.
| Condition |
|---|
|
Glioblastoma Multiforme |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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 |
- To determine if an increase in urinary VEGF and MMP level, from the end of treatment to a patient s one-month follow-up examination following radiotherapy is predictive of one-year recurrence in patients with Glioblastoma multiforme [ Time Frame: One year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2004 |
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 to 99 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- 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
Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00083512
| Contact: Theresa Cooley-Zgela, R.N. | (301) 451-8905 | theresa.cooleyzgela@nih.gov | |
| Contact: Kevin A Camphausen, M.D. | (301) 496-5457 | camphauk@mail.nih.gov |
| 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 | |
| Principal Investigator: | Kevin A Camphausen, M.D. | National Cancer Institute (NCI) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Cancer Institute (NCI) |
| 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: | September 9, 2016 |
| 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 September 30, 2016