Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 8/11/2018 |
| Start Date: | June 22, 2004 |
| Contact: | Theresa Cooley-Zgela, R.N. |
| Email: | theresa.cooleyzgela@nih.gov |
| Phone: | (240) 760-6207 |
Urinary and Serum VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence
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blood are withdrawn through a needle in a vein.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.
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.
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.
- 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.
- 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: (888) NCI-1937
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