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

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00003096
Collaborator
National Cancer Institute (NCI) (NIH)
88
61
122.9
1.4
0

Study Details

Study Description

Brief Summary

RATIONALE: Analyzing the number and structure of genes found in a child's cancer cells may help doctors improve methods of diagnosing and treating children with brain tumors.

PURPOSE: This clinical trial is studying the number and structure of genes in cancer cells of children with brain tumors.

Condition or Disease Intervention/Treatment Phase
  • Genetic: DNA ploidy analysis
  • Genetic: comparative genomic hybridization
  • Genetic: cytogenetic analysis
  • Genetic: fluorescence in situ hybridization

Detailed Description

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.

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.

PROJECTED ACCRUAL: This study will accrue 360 specimens.

Study Design

Study Type:
Observational
Actual Enrollment :
88 participants
Official Title:
Molecular Biology of Pediatric Brain Tumors
Study Start Date :
Dec 1, 1996
Actual Primary Completion Date :
Mar 1, 2006
Actual Study Completion Date :
Mar 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Frequency of specific chromosomal gains, losses and rearrangements in a series of infratentorial and supratentorial PNETS []

    Estimate the frequency of specific chromosomal gains, losses and rearrangements in a series of infratentorial and supratentorial PNETS diagnosed in children

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
  • Not specified
Chemotherapy:
  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified

Contacts and Locations

Locations

Site City State Country Postal Code
1 Phoenix Children's Hospital Phoenix Arizona United States 85016-7710
2 Southern California Permanente Medical Group Downey California United States 90027
3 Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda California United States 92354
4 Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach California United States 90801-1428
5 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles California United States 90048-1865
6 Jonsson Comprehensive Cancer Center at UCLA Los Angeles California United States 90095-1781
7 Children's Hospital Central California Madera California United States 93638-8762
8 Children's Hospital of Orange County Orange California United States 92868
9 Santa Barbara Cottage Children's Hospital Santa Barbara California United States 93105
10 Children's Hospital Center for Cancer and Blood Disorders Aurora Colorado United States 80045
11 Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington Connecticut United States 06360-2875
12 Alfred I. duPont Hospital for Children Wilmington Delaware United States 19803
13 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia United States 20007
14 Children's National Medical Center Washington District of Columbia United States 20010-2970
15 AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Atlanta Georgia United States 30322
16 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia United States 31403-3089
17 Advocate Lutheran General Cancer Care Center Park Ridge Illinois United States 60068-1174
18 Swedish-American Regional Cancer Center Rockford Illinois United States 61104-2315
19 Simmons Cooper Cancer Institute Springfield Illinois United States 62794-9677
20 St. Vincent Indianapolis Hospital Indianapolis Indiana United States 46260
21 Blank Children's Hospital Des Moines Iowa United States 50309
22 Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa United States 52242-1002
23 Kosair Children's Hospital Louisville Kentucky United States 40232
24 Butterworth Hospital at Spectrum Health Grand Rapids Michigan United States 49503-2560
25 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-5381
26 Breslin Cancer Center at Ingham Regional Medical Center Lansing Michigan United States 48910
27 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
28 Masonic Cancer Center at University of Minnesota Minneapolis Minnesota United States 55455
29 Children's Hospitals and Clinics of Minnesota - St. Paul St. Paul Minnesota United States 55102-2392
30 Children's Mercy Hospital Kansas City Missouri United States 64108
31 CCOP - Nevada Cancer Research Foundation Las Vegas Nevada United States 89109-2306
32 Monmouth Medical Center Long Branch New Jersey United States 07740-6395
33 Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown New Jersey United States 07962
34 Overlook Hospital Morristown New Jersey United States 07962
35 Newark Beth Israel Medical Center Newark New Jersey United States 07112
36 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina United States 27599-7295
37 CCOP - MeritCare Hospital Fargo North Dakota United States 58122
38 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229-3039
39 Rainbow Babies and Children's Hospital Cleveland Ohio United States 44106-5000
40 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
41 Nationwide Children's Hospital Columbus Ohio United States 43205-2696
42 Dayton Children's - Dayton Dayton Ohio United States 45404-1815
43 Tod Children's Hospital Youngstown Ohio United States 44501
44 Penn State Children's Hospital Hershey Pennsylvania United States 17033-0850
45 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104-9786
46 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15213
47 Avera Cancer Institute Sioux Falls South Dakota United States 57105
48 East Tennessee Children's Hospital Knoxville Tennessee United States 37901
49 Texas Tech University Health Sciences Center School of Medicine - Amarillo Amarillo Texas United States 79106
50 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
51 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229-3993
52 Primary Children's Medical Center Salt Lake City Utah United States 84113-1100
53 Deaconess Medical Center Spokane Washington United States 99210-0248
54 Gundersen Lutheran Center for Cancer and Blood La Crosse Wisconsin United States 54601
55 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison Wisconsin United States 53792-6164
56 Marshfield Clinic - Marshfield Center Marshfield Wisconsin United States 54449
57 Princess Margaret Hospital for Children Perth Western Australia Australia 6001
58 Children's & Women's Hospital of British Columbia Vancouver British Columbia Canada V6H 3V4
59 IWK Health Centre Halifax Nova Scotia Canada B3J 3G9
60 Allan Blair Cancer Centre at Pasqua Hospital Regina Saskatchewan Canada S4T 7T1
61 Saskatoon Cancer Centre at the University of Saskatchewan Saskatoon Saskatchewan Canada S7N 4H4

Sponsors and Collaborators

  • Children's Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Jaclyn A. Biegel, PhD, Children's Hospital of Philadelphia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00003096
Other Study ID Numbers:
  • B971
  • COG-B971
  • CCG-B971
  • CDR0000065814
First Posted:
Jan 27, 2003
Last Update Posted:
Aug 6, 2014
Last Verified:
Aug 1, 2014

Study Results

No Results Posted as of Aug 6, 2014