Clinical trial NCT00010114: Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children
Official title: Gene Expression Profiling of Infant Embryonal Central Nervous System Tumors by Microarray Gene Chip Analysis: Angiogenesis, Invasion and Metastasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Nervous System Embryonal Neoplasm
Keywords: childhood central nervous system germ cell tumor
childhood choroid plexus tumor
untreated childhood supratentorial primitive neuroectodermal tumor
untreated childhood medulloblastoma
newly diagnosed childhood ependymoma
Lead sponsor: Pediatric Brain Tumor Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-06-06
Enrollment: 83
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Genes that are expressed in metastatic vs. non-metastatic tumors
timeFrame: Prior to therapy
Secondary outcomes:
measure: Protein expression of genes found to be expressed
timeFrame: Prior to therapy
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Cancer Center and Cancer Research Institute
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: Saint Jude Children's Research Hospital
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center - Seattle
state: Washington
Study officials:
affiliation: Children's National Research Institute
name: Tobey MacDonald, MD
role: STUDY_CHAIR
References: