Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Gene Testing to Help in the Diagnosis and Treatment of Childhood Brain Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Genetics	Completed	Under 21	NCI	COG-B971 CCG-B971, NCT00003096

Objectives

1. Determine the chromosomal gains and losses by DNA ploidy analysis and comparative genomic hybridization in patients with primitive neuroectodermal tumors or medulloblastomas.
2. Determine the frequency of specific chromosomal abnormalities, including deletions of chromosomal regions 6, 17, and 22, in these patients.
3. Perform a statistical analysis to determine possible associations of chromosomal abnormalities and DNA ploidy with patient age, tumor histology, tumor location, extent of disease, and event-free survival.

Entry Criteria

Disease Characteristics:

• Histologically confirmed primary CNS malignancy consistent with primitive neuroectodermal tumor, medulloblastoma, or atypical teratoid/rhabdoid tumor



• Must be entered on CCG-9921, CCG-9931, CCG-A9961, CCG-99703 or other front-line studies developed from CCG-90024 or CCG-90025



• Retrospective specimens also obtained from CCG-921, CCG-923, CCG-9892, CCG-9921, and CCG-9931

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Patient Characteristics:

Age:

• Under 21

Performance status:

• See Disease Characteristics

Life expectancy:

• See Disease Characteristics

Hematopoietic:

• See Disease Characteristics

Hepatic:

• See Disease Characteristics

Renal:

• See Disease Characteristics

Expected Enrollment

This study will accrue 360 specimens.

Outline

DNA ploidy analysis will be performed to determine the overall level of aneuploidy. The results are compared to the comparative genomic hybridization (CGH) analysis, which is used to demonstrate tumor-specific losses or gains, including amplification, of specific chromosomal regions. Tumors are also screened for specific abnormalities by fluorescent in situ hybridization (FISH), which detects chromosomal rearrangements, including balanced translocations, deletions, amplifications, etc. PCR-based microsatellite polymorphism analysis may also be performed.

Primitive neuroectodermal tumors (PNETs) are screened by FISH with a distal 17p13.3 cosmid and a 17q25 cosmid to identify tumors with a 17p deletion. Atypical teratoid/rhabdoid tumors and PNETs without a 17p deletion are screened by FISH with a series of cosmids from 22q11.2. PNETs are also screened by interphase FISH with cosmids from chromosome 6 to identify tumors with deletions.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Jaclyn Biegel, PhD, Protocol chair		Ph: 215-590-2947

Related Information

PDQ® clinical trial CCG-A9961
PDQ® clinical trial COG-99703
PDQ® clinical trial CCG-921
PDQ® clinical trial CCG-923
PDQ® clinical trial CCG-9892

Registry Information
Official Title		Molecular Biology of Pediatric Brain Tumors
Trial Start Date		1997-12-01
Registered in ClinicalTrials.gov		NCT00003096
Date Submitted to PDQ		1997-09-29
Information Last Verified		2005-11-29
NCI Grant/Contract Number		CA13539

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