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An Exploratory Study of Biologic and Pathophysiologic Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors


N/A
N/A
21 Years
Open (Enrolling)
Both
Radiation Therapy

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Trial Information

An Exploratory Study of Biologic and Pathophysiologic Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors


Background:

This exploratory study will be performed in pediatric patients with CNS tumors who are
undergoing radiation therapy to investigate pathophysiologic effects of radiation on the
CNS. The study includes the analysis of blood, urine, and CSF (if available) to measure
biological markers involved with angiogenesis, blood: brain barrier integrity, and
neurotoxicity. It also entails comprehensive MR imaging techniques and neuropsychological
testing in an effort to correlate changes with biomarker measurements.

Objectives:

Primary Objectives

1. To detect changes in angiogenesis related to radiation of the CNS by:

- Measurement of VEGF, bFGF, thrombospondin, TNF-alpha, IL-12, IL-8, and MMP in
blood and urine specimens.

- MR perfusion and DEMRI.

2. To describe changes in blood:brain barrier permeability associated with radiation of
the CNS.

3. To characterize neurotoxicity by:

- Measuring biomarkers associated with neurotoxicity, including NF-1, NSE,
S100-Beta, GFAP, and quinolinic acid in blood and CSF.

- Documenting changes in neurobehavioral functioning through longitudinal
comprehensive assessments

- Describing changes in quality of life (QOL)

- Assessing changes in memory

- Defining changes in ophthalmologic studies associated with radiation.

- Detecting changes in audiometry associated with radiation.

Eligibility Criteria:

- Patients must have a primary CNS tumor for which radiation therapy is recommended.

- Patients must be less than or equal to 21 yrs of age.

- Prior/Concurrent: Patients will be eligible if they have not received prior radiation.
Patients who have undergone surgery or received chemotherapy are eligible.

- Performance Status: Patients will be eligible regardless of performance score.

Design:

This minimally invasive study is designed to explore various biologic effects of radiation
on the pediatric CNS in an attempt to 1) obtain information on the pathophysiology of
radiation-induced damage, 2) explore the association of neuropsychological deficits with
biologic markers and neuroimaging abnormalities, 3) document changes in neurobehavioral
functioning through longitudinal comprehensive neuropsychological assessments with
comparison of various radiation therapy techniques, 4) describe changes in quality of life
in pediatric patients who have received radiation therapy, and 5) attempt to identify
children at increased risk of radiation-induced neurotoxicity.

Inclusion Criteria


- INCLUSION CRITERIA:

Age: Patients must be less than or equal 21 yrs of age.

Tumor: Any primary CNS tumor.

Referred for radiation therapy at NCI.

Signed informed consent by patient, parent or legal guardian.

PERFORMANCE SCORE: any.

PRIOR/CONCURRENT THERAPY: Patients will be eligible if they have not received prior
radiation.

Patients who have undergone prior surgery or who have received chemotherapeutic regimens
are eligible.

EXCLUSION CRITERIA:

Patients who have received prior radiation.

Patients who are unable to have MRI performed for any reason.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Katherine E Warren, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

060219

NCT ID:

NCT01445288

Start Date:

July 2006

Completion Date:

Related Keywords:

  • Radiation Therapy
  • Neurotoxicity
  • Brain Tumor
  • Children
  • Angiogenesis
  • Imaging
  • Central Nervous System Tumor
  • CNS Tumor
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892
Childrens National Medical CenterWashington, District of Columbia