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

Central Nervous System Embryonal Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00010114
• Other study ID #: CDR0000068446
• Secondary ID: PBTC-N04
• Status: Completed
• Phase: N/A
• First received: February 2, 2001
• Last updated: July 19, 2011
• Start date: March 2001
• Est. completion date: March 2003

Study information

• Verified date: July 2011
• Source: Pediatric Brain Tumor Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Central Nervous System Embryonal Neoplasm
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Saint Jude Children's Research Hospital	Memphis	Tennessee
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Pediatric Brain Tumor Consortium	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genes that are expressed in metastatic vs. non-metastatic tumors		Prior to therapy	No
Secondary	Protein expression of genes found to be expressed		Prior to therapy	No