Biomarkers in Blood Samples From Young Patients With Newly Diagnosed Brain Tumors Undergoing Standard Radiation Therapy and Chemotherapy

Study Overview
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Brief Summary
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RATIONALE: Studying samples of blood in the laboratory from patients receiving radiation therapy and chemotherapy may help doctors learn more about the effects of this treatment on cells. It may also help doctors understand how well patients respond to treatment. PURPOSE: This research study is studying biomarkers in blood samples from young patients with newly diagnosed brain tumors undergoing standard radiation therapy and chemotherapy.

Detailed Description
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OBJECTIVES: Primary Evaluate the fraction of peripherally circulating T-regulatory cells (T_regs) in pediatric patients with newly diagnosed medulloblastoma and compare it to the levels found in a control group of patients undergoing craniectomy for Chiari malformation. Evaluate the longitudinal effects of standard radiotherapy and chemotherapy regimens on the overall population of lymphocytes as well as the fraction of T_reg cells in patients with medulloblastoma. Secondary Determine the baseline fraction of T_reg cells in those with non-medulloblastoma posterior fossa tumors compared to levels found in patients undergoing decompression for Chiari malformation. OUTLINE: This is a multicenter study. Patients with Chiari malformation and patients with posterior fossa tumor undergo standard surgery. Patients with posterior fossa tumor also receive standard radiotherapy and chemotherapy. Blood samples are collected at baseline and periodically to measure the level of circulating T-regulatory cells.

Official Title
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Immunologic Profile of Patients With Newly Diagnosed Medulloblastoma at Initial Diagnosis and During Standard Radiation and Chemotherapy

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: systemic chemotherapy
* Other: laboratory biomarker analysis
* Procedure: therapeutic surgical procedure
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Histologically confirmed posterior fossa tumor Newly diagnosed disease Medulloblastoma OR non-medulloblastoma (pilocytic astrocytoma, ependymoma, atypical rhabdoid tumor, or others) Scheduled to undergo craniotomy and tumor resection Chiari malformation Requires craniectomy for decompression No secondary decompression PATIENT CHARACTERISTICS: No unexplained febrile illness No active infection No autoimmune disorders such as inflammatory bowel disease, juvenile rheumatoid arthritis, or systemic lupus erythematosus No other immunosuppressive disorders (e.g., HIV infection) PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: systemic chemotherapy|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: therapeutic surgical procedure|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation |  |  | 
| Longitudinal side effects of standard radiotherapy and chemotherapy regimens on the overall population of lymphocytes as well as the fraction of circulating T-reg cells |  |  | 
| Effect of treatment on lymphocytes and T-reg cells |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline fraction of circulating T-reg cells |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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untreated childhood medulloblastoma, untreated childhood cerebellar astrocytoma, untreated childhood cerebral astrocytoma, untreated childhood brain stem glioma, childhood medulloepithelioma, childhood infratentorial ependymoma, newly diagnosed childhood ependymoma, childhood atypical teratoid/rhabdoid tumor