Biomarkers in Blood Samples From Young Patients With Newly Diagnosed Brain Tumors Undergoing Standard Radiation Therapy and Chemotherapy
NCT ID: NCT01233479
Last Updated: 2019-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2010-05-31
2017-08-24
Brief Summary
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PURPOSE: This research study is studying biomarkers in blood samples from young patients with newly diagnosed brain tumors undergoing standard radiation therapy and chemotherapy.
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Detailed Description
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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.
Conditions
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Study Design
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BASIC_SCIENCE
NONE
Interventions
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systemic chemotherapy
laboratory biomarker analysis
therapeutic surgical procedure
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
4 Years
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Pediatric Brain Tumor Consortium
NETWORK
Responsible Party
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Pediatric Brain Tumor Consortium
Principal Investigators
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Sri Gururangan, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Cancer Institute
Locations
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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
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
NCI - Pediatric Oncology Branch
Bethesda, Maryland, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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PBTC-N11
Identifier Type: -
Identifier Source: secondary_id
CDR0000673892
Identifier Type: -
Identifier Source: org_study_id
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