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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease
Central Nervous System Embryonal Neoplasm

Detailed 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.

Study Design

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Study Type :	Observational
Actual Enrollment :	83 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Gene Expression Profiling of Infant Embryonal Central Nervous System Tumors by Microarray Gene Chip Analysis: Angiogenesis, Invasion and Metastasis
Study Start Date :	March 2001
Actual Primary Completion Date :	March 2003
Actual Study Completion Date :	March 2003

Groups and Cohorts

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Group/Cohort

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

Outcome Measures

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Primary Outcome Measures :

1. Genes that are expressed in metastatic vs. non-metastatic tumors [ Time Frame: Prior to therapy ]

Secondary Outcome Measures :

1. Protein expression of genes found to be expressed [ Time Frame: Prior to therapy ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 2 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Pediatric Brain Tumor Consortium

National Cancer Institute (NCI)

Investigators

Study Chair:	Tobey MacDonald, MD	Children's Research Institute

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	James M. Boyett, Executive Director Operations and Biostatistics Center, Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier:	NCT00010114 History of Changes
Other Study ID Numbers:	CDR0000068446; PBTC-N04
First Posted:	June 6, 2003
Last Update Posted:	July 20, 2011
Last Verified:	July 2011

Keywords provided by Pediatric Brain Tumor Consortium:

childhood central nervous system germ cell tumor; childhood choroid plexus tumor; untreated childhood supratentorial primitive neuroectodermal tumor; untreated childhood medulloblastoma; newly diagnosed childhood ependymoma

Additional relevant MeSH terms:

Nervous System Neoplasms; Central Nervous System Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Site	Neoplasms; Nervous System Diseases; Neoplasms by Histologic Type