Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information
Gene Testing to Help in the Diagnosis and Treatment of Childhood Brain Tumors
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Genetics | Completed | Under 21 | NCI | COG-B971 CCG-B971, NCT00003096 |
Objectives
- Determine the chromosomal gains and losses by DNA ploidy analysis and comparative genomic hybridization in patients with primitive neuroectodermal tumors or medulloblastomas.
- Determine the frequency of specific chromosomal abnormalities, including deletions of chromosomal regions 6, 17, and 22, in these patients.
- 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 Lead Organizations
Children's Oncology Group
| Jaclyn Biegel, PhD, Protocol chair |
| ||
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 | 2010-11-12 | |
| NCI Grant/Contract Number | CA13539 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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