Diffuse Intrinsic Pontine GliomaNCT01445288
Exploratory Study of Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors
An observational study of Diffuse Intrinsic Pontine Glioma and PNET, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- Diffuse Intrinsic Pontine Glioma, PNET, Ependymoma
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2006to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients 21 years of age or younger with CNS tumors for which radiation therapy is recommended@@@
Who may be able to join
- 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.
Who cannot join
- Patients who have received prior radiation.
- Patients who are unable to have MRI performed for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: An Exploratory Study of Biologic and Pathophysiologic Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors
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.
Read the 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:
- 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.
- To describe changes in blood:brain barrier permeability associated with radiation of the CNS.
- To 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.
Eligibility Criteria:
- Patients must have a primary CNS tumor for which radiation therapy is recommended.
- Patients must be less than or equal to 21 years 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.
- Conditions
- Diffuse Intrinsic Pontine Glioma, PNET, Ependymoma, Germinoma, Medulloblastoma
- Keywords
- Neurotoxicity, Brain Tumor, Children, Angiogenesis, Imaging, Natural History, Central Nervous System Tumor, CNS Tumor
- Medical subject headings
- Diffuse Intrinsic Pontine Glioma, Neuroectodermal Tumors, Primitive, Ependymoma, Germinoma, Medulloblastoma, Neurotoxicity Syndromes, Brain Neoplasms, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Pediatric Patients with Central Nervous System Tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before and up to 8 years after
Secondary outcomes (2)
Describe changes in imaging, endocrine function after xrt to the brain
Measurement of S100-beta and transthyretin in blood
Measured: before and up to 8 years after
Monitor changes in serum proteome and germline polymorphisms
Assesed changed in memory, QOL, neurobehavioral functioning, ophthalmologic studies, and audiometry associated with radiation
Measured: before and up to 8 years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study start5 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diffuse Intrinsic Pontine GliomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John W Glod, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445288
- Sponsor's protocol ID
- 060219
- Other IDs
- 06-C-0219
- Status last verified
- 15 Sep 2026
- First submitted
- 30 Sep 2011
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Publications
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.
PubMed 12750523Wyllie 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.
PubMed 7014501Mulhern 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.
PubMed 1574027