Biomarkers in Blood Samples From Young Patients With Newly Diagnosed Brain Tumors Undergoing Standard Radiation Therapy and Chemotherapy
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT01233479
- Lead Sponsor
- Pediatric Brain Tumor Consortium
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of treatment on lymphocytes and T-reg cells 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 Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation
- Secondary Outcome Measures
Name Time Method Baseline fraction of circulating T-reg cells
Trial Locations
- Locations (11)
Lucile Packard Children's Hospital at Stanford University Medical Center
🇺🇸Palo Alto, California, United States
NCI - Pediatric Oncology Branch
🇺🇸Bethesda, Maryland, United States
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
🇺🇸Houston, Texas, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States