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

• Sponsor: Pediatric Brain Tumor Consortium (Other)
• Overall Status: Completed
• CT.gov ID: NCT00010114
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 83
• Locations: 9
• Duration (Months): 24
• Patients Per Site: 9.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	Intervention/Treatment	Phase
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

• 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: Mar 1, 2001
• Actual Primary Completion Date: Mar 1, 2003
• Actual Study Completion Date: Mar 1, 2003

Arms and Interventions

Arm

Intervention/Treatment

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 2 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94143-0128
2	Children's National Medical Center	Washington	District of Columbia	United States	20010-2970
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
4	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
5	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
6	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
7	Saint Jude Children's Research Hospital	Memphis	Tennessee	United States	38105-2794
8	Baylor College of Medicine	Houston	Texas	United States	77030
9	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 National Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00010114
• Other Study ID Numbers: CDR0000068446; PBTC-N04
• First Posted: Jun 6, 2003
• Last Update Posted: Jul 20, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: 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

Study Results

No Results Posted as of Jul 20, 2011