Brain Tumor
An Exploratory Study of Biologic and Pathophysiologic Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors
NCI-06-C-0219, NCT00401037
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Investigator(s): |
Katherine E. Warren, M.D.
Principal Investigator
Phone: 301-496-4256
Fax: 301-480-2308
warrenk@mail.nih.gov
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Linda Ellison, R.N.
Research Nurse
Phone: 301-496-8009
Fax: 301-480-8871
ellisonl@mail.nih.gov
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Pediatric Oncology
Phone: 301-496-4256
1-877-624-4878 (Toll free)
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Background:
- This exploratory study will be performed in pediatric patients with central nervous system (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:
- Detect changes in angiogenesis related to radiation of the CNS by:
- Measurement of VEGF, bFGF, thrombospondin, TNF-α, IL-12, IL-8, and MMP in blood and urine specimens MR perfusion and DEMRI
- Describe changes in blood: brain barrier permeability associated with radiation of the central nervous system
- Characterize neurotoxicity by:
- Measuring biomarkers associated with neurotoxicity
- 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
Key Eligibility Criteria:
- Primary central nervous system tumor for which radiation therapy is recommended
- ≤ 21 years of age
- No prior radiotherapy
- Prior surgery allowed
- Prior and concurrent chemotherapy allowed
- Concurrent enrollment on another clinical trial using investigational agents allowed
- Concurrent corticosteroids allowed
- Patients will be eligible regardless of performance status
- Able to undergo an MRI
Study Outline:
- Blood, urine, and cerebrospinal fluid (if available) collection for evaluation of post-radiotherapy changes using immunoenzyme techniques, bioluminescence, and mass spectrometry (biomarker studies)
- Blood collection for analysis of DNA for polymorphisms associated with an increased susceptibility to the neurotoxic effects of radiotherapy (genetic studies)
- Some patients undergo radiographic imaging by standard and dynamic contrast-enhanced MRI, proton nuclear magnetic resonance spectroscopy, MR perfusion, and diffusion-tensor MRI at baseline, 1–2 weeks, and 6–8 weeks after completion of radiotherapy, and then at 6 months, 12 months, and then annually for 5 years
- Neuropsychological assessments at baseline, within 2 weeks after completion of radiotherapy, and then at 6 months and 12 months and then annually
- Quality of life assessments at baseline, within approximately 2 weeks after completion of radiotherapy, at 6 months, 12 months, and then annually
- Ophthalmologic testing at baseline, at 6 months after completion of radiotherapy, and then annually
- Age-appropriate audiometric testing at baseline, within 2 weeks, 6–8 weeks after completion of radiotherapy, 6 months, 12 months, and then annually
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 12/14/12
Updated: 8/1/12
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