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Diffuse Intrinsic Pontine Glioma | Exploratory Study of Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors

Diffuse Intrinsic Pontine Glioma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

- 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Diffuse Intrinsic Pontine Glioma

PNET

Ependymoma

Germinoma

Medulloblastoma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Recruiting

Start Date: August 1, 2006

Completed Date:

Phase:

Type: Observational

Design:

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

Secondary Outcome: Describe changes in imaging, endocrine function after xrt to the brain

Study sponsors, principal investigator, and references

Principal Investigator: Katherine E Warren, M.D.

Lead Sponsor: National Cancer Institute (NCI)

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01445288

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.

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