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Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children - Article


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Germ Cell Tumor, Extracranial, Childhood

 




Clinical Trial: Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
Pediatric Brain Tumor Consortium
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer. PURPOSE: Genetic study to learn more about genes involved in the development of central nervous system tumors in young children.

Condition Treatment or Intervention
childhood choroid plexus tumor
childhood central nervous system germ cell tumor
untreated childhood supratentorial primitive neuroectodermal tumors
untreated childhood medulloblastoma
newly diagnosed childhood ependymoma
 Procedure: genetics

MedlinePlus related topics:  Brain Cancer;   Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Treatment

Official Title: Genetic Study of Infants With Newly Diagnosed Embryonal Central Nervous System Tumors

Further Study Details: 

Study start: March 2001

OBJECTIVES: I. 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. II. 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. III. Determine the quantity of gene expression of the confirmed translationally expressed genes using semi-quantitative polymerase chain reaction.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  up to  2 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

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

--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

--Patient Characteristics--

  • Age: Under 3
  • Performance status: Not specified
  • Life expectancy: Not specified
  • Hematopoietic: Not specified
  • Hepatic: Not specified
  • Renal: Not specified

Location Information


California
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94143-0128,  United States

District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010-2970,  United States

Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States

      Children's Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States

Tennessee
      Saint Jude Children's Research Hospital, Memphis,  Tennessee,  38105-2794,  United States

Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States

Washington
      Children's Hospital and Regional Medical Center - Seattle, Seattle,  Washington,  98105,  United States

Study chairs or principal investigators

Tobey MacDonald,  Study Chair,  Pediatric Brain Tumor Consortium   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068446; PBTC-N04
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010114
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: September 23, 2004
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