Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children
NCT ID: NCT00010114
Last Updated: 2011-07-20
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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COMPLETED
83 participants
OBSERVATIONAL
2001-03-31
2003-03-31
Brief Summary
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PURPOSE: Genetic study to learn more about genes involved in the development of central nervous system tumors in young children.
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Detailed Description
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* Identify known genes that have significantly different levels of expression, using microarray gene chip analysis, in infants with newly diagnosed metastatic vs non-metastatic embryonal central nervous system tumors.
* Determine the protein expression of genes identified by microarray analysis that are involved in cellular functions that regulate angiogenesis, invasion, or metastasis in this patient population.
* Determine the quantity of gene expression of the confirmed translationally expressed genes using semi-quantitative polymerase chain reaction.
OUTLINE: This is a multicenter study.
Tumor samples are analyzed using microarray gene chip analysis. Differentially expressed genes are evaluated for protein expression by standard immunohistochemistry and/or Western blot analysis, and gene expression is further quantified by semi-quantitative polymerase chain reaction.
PROJECTED ACCRUAL: Approximately 80-100 patients (20-25 with metastatic disease and 60-75 with non-metastatic disease) will be accrued for this study within 4-5 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Newly diagnosed embryonal tumors
The participants in this study are infants (\< 3 years of age) with newly diagnosed medulloblastoma, primitive neuroectodermal tumor, or other embryonal tumor, atypical teratoid/rhabdoid tumor, intracranial germ cell tumor, or choroid plexus carcinoma who have received no prior therapy with the exception of steroids and have consented to allow research studies on banked tissue specimens
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed, newly diagnosed, primary intracranial embryonal central nervous system tumor
* Medulloblastoma
* Primitive neuroectodermal tumor
* Medulloepithelioma
* Ependymoblastoma
* Neuroblastoma
* Pineoblastoma
* Atypical teratoid/rhabdoid tumor
* Intracranial germ cell tumor
* Choroid plexus carcinoma
* M positive ependymoma
* Potential enrollment on PBTC-001 therapeutic protocol
PATIENT CHARACTERISTICS:
Age:
* Under 3
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Prior steroids allowed
Radiotherapy:
* No prior radiotherapy
Surgery:
* Not specified
Other:
* No concurrent investigational agents
2 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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Tobey MacDonald, MD
Role: STUDY_CHAIR
Children's National Research Institute
Locations
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UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Countries
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Other Identifiers
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PBTC-N04
Identifier Type: -
Identifier Source: secondary_id
CDR0000068446
Identifier Type: -
Identifier Source: org_study_id
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