Protocol Details

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 is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	04-C-0200
Sponsoring Institute	National Cancer Institute (NCI)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required	No
Population Exclusion(s)	Children; Fetuses; Neonates; Pregnant Women
Keywords	Blood; Urine; GBM; Radiation; Natural History
Recruitment Keyword(s)	Glioblastoma Multiforme
Condition(s)	Glioblastoma Multiforme
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Cancer Institute

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 Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein.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.

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Eligibility

INCLUSION CRITERIA:

Age greater than or equal to 18 years.

Histologically confirmed supratentorial Glioblastoma multiforme.

Karnofsky performance >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 non-melanomatous skin cancers or carcinoma in situ.

Gliadel wafer placement at the time of surgery.

Pregnancy because radiation has the potential for teratogenic or abortifacient effects.

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Citations:

Not Provided

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Contacts:

Principal Investigator	Referral Contact	For more information:
Kevin A. Camphausen, M.D. National Cancer Institute (NCI) NIHBC 10 - CRC BG RM B2-3675 10 CENTER DR BETHESDA MD 20892 (240) 760-6205 camphauk@mail.nih.gov	Theresa Cooley Zgela, R.N. National Cancer Institute (NCI) National Institutes of Health Building 10 Room B2-5530 10 Center Drive Bethesda, Maryland 20892 (301) 451-8905 theresa.cooleyzgela@nih.gov	NCI Referral Office National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office 1-888-NCI-1937 ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT00083512

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