Exploratory Study of Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01445288
First received: September 30, 2011
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

This study will analyze the effects of radiation given to children who have tumors of the central nervous system (CNS). Researchers want to learn more about changes in the quality of life that patients may experience as a result of radiation.

Patients ages 21 and younger who have a primary CNS tumor and who have not received radiation previously may be eligible for this study. They will have a medical history and physical examination. Collection of blood (about 2-1/2 tablespoons) and urine will be done, as well as a pregnancy test. Patients will complete neuropsychological tests, which provide information about their changes in functioning over time. An expert in psychology will give a number of tests, and the patient's parents or guardian will be asked to complete a questionnaire about the patient's behavior. Also, patients will be given a quality of life questionnaire to complete and vision and hearing tests. The radiation itself is prescribed by patients' doctors and is not part of this study.

Magnetic resonance imaging (MRI) will give researchers information about the tumor and brain, through several scanning sequences . MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. Patients will lie on a table that slides into the enclosed tunnel of the scanner. They will need to lie still, and medication may be given to help them to do that. They may be in the scanner for up to 2 hours. As the scanner takes pictures, patients will hear knocking or beeping sounds, and they will wear earplugs to reduce the noise. A contrast agent will be administered, to allow images be seen more clearly. Blood and urine tests will be conducted after the first dose of radiation. MRI scans will be done 2 weeks after patients finish radiation therapy and again at 6 to 8 weeks, 6 months, 12 months, and yearly. Also at those follow-up periods, patients will undergo similar procedures as previously, including blood and urine tests and neuropsychological testing. Patients can remain in this study for 5 years.


Condition
Radiation Therapy

Study Type: Observational
Official Title: An Exploratory Study of Biologic and Pathophysiologic Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 150
Study Start Date: July 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445288

Contacts
Contact: Robyn Bent, R.N. (301) 496-4256 rbent@mail.nih.gov
Contact: Katherine E Warren, M.D. (301) 435-4683 warrenk@mail.nih.gov

Locations
United States, District of Columbia
Childrens National Medical Center Recruiting
Washington, District of Columbia, United States
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Japan
Gifu University School of Medicine Recruiting
Gifu, Japan
Sponsors and Collaborators
Investigators
Principal Investigator: Katherine E Warren, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01445288     History of Changes
Other Study ID Numbers: 060219, 06-C-0219
Study First Received: September 30, 2011
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Neurotoxicity
Brain Tumor
Children
Angiogenesis
Imaging
Central Nervous System Tumor
CNS Tumor

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014