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

Gene Expression Profiling of Infant Embryonal Central Nervous System Tumors by Microarray Gene Chip Analysis: Angiogenesis, Invasion and Metastasis

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Genes that are expressed in metastatic vs. non-metastatic tumors	Prior to therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Protein expression of genes found to be expressed	Prior to therapy

Collaborators and Investigators

• Sponsor: Pediatric Brain Tumor Consortium
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Tobey MacDonald, MD, Children's National Research Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2001
• Primary Completion (Actual): March 1, 2003
• Study Completion (Actual): March 1, 2003

Study Registration Dates

• First Submitted: February 2, 2001
• First Submitted That Met QC Criteria: June 5, 2003
• First Posted (Estimate): June 6, 2003

Study Record Updates

• Last Update Posted (Estimate): July 20, 2011
• Last Update Submitted That Met QC Criteria: July 19, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: untreated childhood medulloblastoma; newly diagnosed childhood ependymoma; childhood central nervous system germ cell tumor; childhood choroid plexus tumor; untreated childhood supratentorial primitive neuroectodermal tumor
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Germ Cell and Embryonal; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: CDR0000068446; PBTC-N04