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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

06-C-0219

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 1 mo
Max Age: 21 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Neurotoxicity;
Brain Tumor;
Children;
Angiogenesis;
Imaging;
Natural History

Recruitment Keyword(s)

Brain Tumor;
Central Nervous System Tumor;
CNS Tumor

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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Eligibility

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

Patients who have received prior radiation.

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


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Citations:

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.

Wyllie AH, Kerr JF, Currie AR Cell death: the significance of apoptosis Int Rev Cytol. 1980;68:251-306.

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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

John W. Glod, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-3750
10 CENTER DR
BETHESDA MD 20892
(240) 760-6194
john.glod@nih.gov

John W. Glod, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-3750
10 CENTER DR
BETHESDA MD 20892
(240) 760-6194
john.glod@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01445288

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