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

Pediatric Brain Tumor Consortium

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Brain and Central Nervous System Tumors

Interventions

systemic chemotherapyDRUG

laboratory biomarker analysisOTHER

therapeutic surgical procedurePROCEDURE

radiation therapyRADIATION

Eligibility

Sex: ALLMin age: 4 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (11)

Childrens Hospital Los Angeles

Los Angeles, California, United States

Lucile Packard Children's Hospital at Stanford University Medical Center

Palo Alto, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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 Outcomes

Baseline fraction of circulating T-reg cells

Data from ClinicalTrials.gov

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