NIH Clinical Research Studies

Protocol Number: 04-C-0200

Active Accrual, Protocols Recruiting New Patients

Title:
Urinary and Serum VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence
Number:
04-C-0200
Summary:
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 Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle n a vein.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.

Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility 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

HIV positivity

Special Instructions: Currently Not Provided
Keywords:
Blood
Urine
GBM
Radiation
Recruitment Keywords:
Glioblastoma Multiforme
Conditions:
Glioblastoma
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Folkman J. Tumor angiogenesis: therapeutic implications.

N Engl J Med. 1971 Nov 18;285(21):1182-6. PMID: 4938153

Chan LW, Moses MA, Goley E, Sproull M, Muanza T, Coleman CN, Figg WD, Albert PS, Menard C, Camphausen K. Urinary VEGF and MMP levels as predictive markers of 1-year progression-free survival in cancer patients treated with radiation therapy: a longitudinal study of protein kinetics throughout tumor progression and therapy. J Clin Oncol. 2004 Feb 1;22(3):499-506. PMID: 14752073

Smith BD, Smith GL, Carter D, Sasaki CT, Haffty BG. Prognostic significance of vascular endothelial growth factor protein levels in oral and oropharyngeal squamous cell carcinoma. J Clin Oncol. 2000 May;18(10):2046-52. PMID: 10811669

Active Accrual, Protocols Recruiting New Patients

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