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

NCT01445288 | Completed

• 2 other identifiers: 06021906-C-0219
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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. ...

Conditions

Diffuse Intrinsic Pontine Glioma; PNET; Ependymoma; Germinoma; Medulloblastoma

Keywords

Neurotoxicity; Brain Tumor; Children; Angiogenesis; Imaging; Natural History; Central Nervous System Tumor; CNS Tumor

Outcome Measures

Primary Outcomes (1)

• Measure changes in antiogenesis, blood brain barrier permability and neurotoxicity re to radiation of the CNS

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

  before and up to 8 years after

Secondary Outcomes (2)

• Describe changes in imaging, endocrine function after xrt to the brain

  before and up to 8 years after

• Monitor changes in serum proteome and germline polymorphisms

  before and up to 8 years after

Study Arms (1)

1

Pediatric Patients with Central Nervous System Tumors

Eligibility Criteria

• Age: 1 Month - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients 21 years of age or younger with CNS tumors for which radiation therapy is recommended@@@

You may qualify if:

• Age: Patients must be less than or equal 21 years 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.

You may not qualify if:

• Patients who have received prior radiation.
• Patients who are unable to have MRI performed for any reason.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Garcia-Barros M, Paris F, Cordon-Cardo C, Lyden D, Rafii S, Haimovitz-Friedman A, Fuks Z, Kolesnick R. Tumor response to radiotherapy regulated by endothelial cell apoptosis. Science. 2003 May 16;300(5622):1155-9. doi: 10.1126/science.1082504.

  PMID: 12750523 BACKGROUND

• Wyllie AH, Kerr JF, Currie AR. Cell death: the significance of apoptosis. Int Rev Cytol. 1980;68:251-306. doi: 10.1016/s0074-7696(08)62312-8. No abstract available.

  PMID: 7014501 BACKGROUND

• Mulhern RK, Hancock J, Fairclough D, Kun L. Neuropsychological status of children treated for brain tumors: a critical review and integrative analysis. Med Pediatr Oncol. 1992;20(3):181-91. doi: 10.1002/mpo.2950200302.

  PMID: 1574027 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Diffuse Intrinsic Pontine Glioma; Neuroectodermal Tumors, Primitive; Ependymoma; Germinoma; Medulloblastoma; Neurotoxicity Syndromes; Brain Neoplasms; Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Stem Neoplasms; Infratentorial Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• John W Glod, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 3, 2011
• Study Start: December 5, 2006
• Last Updated: April 24, 2026

Record last verified: 2025-10-24

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as the database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)