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

Pediatric Brain Tumor Consortium logo

Pediatric Brain Tumor Consortium

Status

Completed

Conditions

Central Nervous System Embryonal Neoplasm

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT00010114
PBTC-N04
CDR0000068446

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

  • 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.

Enrollment

83 patients

Sex

All

Ages

Under 2 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

83 participants in 1 patient group

Newly diagnosed embryonal tumors
Description:
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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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