Full Text View
Tabular View
No Study Results Posted
Related Studies
Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma
This study has been completed.
First Received: January 4, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028795
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation therapy after surgery followed by chemotherapy alone works in children with newly diagnosed astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: temozolomide
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Improved outcome [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v. 2.0 [ Designated as safety issue: Yes ]

Study Start Date: December 2002
Detailed Description:

OBJECTIVES:

  • Compare the event-free survival of patients with newly diagnosed anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma (DIPG) treated with adjuvant temozolomide administered concurrently with postoperative radiotherapy and then alone as maintenance therapy vs historical control cohorts treated in prior Pediatric Oncology Group and Children's Cancer Group studies.
  • Determine the toxicity of this regimen in these patients.
  • Determine the efficacy of this regimen in patients with DIPG.
  • Determine the toxicity of this regimen in patients with DIPG.

OUTLINE: This is a multicenter study.

  • Adjuvant chemoradiotherapy: Beginning within 6 weeks after surgical resection or diagnosis*, patients without gross residual disease undergo cranial irradiation 5 days a week for 6 weeks. Beginning within 6 weeks after surgical resection, patients with gross residual disease undergo radiotherapy as above followed by boost radiotherapy for 1 week. All patients receive oral temozolomide once daily beginning within 5 days after initiation of radiotherapy and continuing for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.
  • Adjuvant maintenance therapy: Beginning 4 weeks after completion of adjuvant chemoradiotherapy, patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *For patients with diffuse intrinsic pontine glioma only

Patients are followed every 3-6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 50-60 patients will be accrued for this study within 12-14 months.

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed CNS tumor of the following types:

    • High grade glioma (HGG) of one of the following histologies:

      • Anaplastic astrocytoma (grade III)
      • Glioblastoma multiforme (grade IV)
      • Gliosarcoma
      • Primary spinal cord malignant glioma
    • Diffuse intrinsic pontine glioma (DIPG)

      • Diagnosed by gadolinium-enhanced MRI
      • At least 2/3 of tumor situated in the pons AND tumor clearly originated in the pons
      • No diffuse leptomeningeal disease
      • No tumors with features not typical of diffuse intrinsic brainstem glioma, including any of the following:

        • Dorsally exophytic brainstem glioma
        • Cervico-medullary junction tumor
        • Focal low-grade glioma of the midbrain or brainstem
      • No diffuse brainstem enlargement due to neurofibromatosis
  • No primary brain stem malignant glioma
  • No M+ disease (CSF positive for tumor or metastatic disease)
  • Must begin study radiotherapy within 6 weeks after surgical resection (for HGG patients) or diagnosis (for DIPG patients)

PATIENT CHARACTERISTICS:

Age:

  • 3 to 21

Performance status:

  • Karnofsky 50-100% OR
  • Lansky 50-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3*
  • Hemoglobin at least 10.0 g/dL* NOTE: *Transfusion independent

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT less than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • No other concurrent malignancy
  • Concurrent seizure disorder allowed if well controlled on anticonvulsants
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after completion of study treatment

PRIOR CONCURRENT THERAPY:

Biologic:

  • No concurrent routine cytokine support

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No concurrent corticosteroids except for increased intracranial pressure in patients with CNS tumors

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics

Other:

  • No prior therapy for HGG or DIPG
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028795

  Hide Study Locations
Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
University of South Alabama Cancer Research Institute
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Children's Hospital and Health Center - San Diego
San Diego, California, United States, 92123-4282
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801-1428
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Children's Hospital of Orange County
Orange, California, United States, 92868
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
General Robert Huyser Cancer Center at David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States, 95051-5386
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States, 92120
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States, 94304
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93102
Southern California Permanente Medical Group
Downey, California, United States, 90242
Sutter Cancer Center
Sacramento, California, United States, 95816
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Colorado
Children's Hospital Cancer Center
Denver, Colorado, United States, 80218
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-7106
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8064
United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176-2197
Miami Children's Hospital
Miami, Florida, United States, 33155
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Joe DiMaggio Children's Hospital at Memorial
Hollywood, Florida, United States, 33021
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Nemours Children's Clinic-Orlando
Orlando, Florida, United States, 32806
Sacred Heart Children's Hospital
Pensacola, Florida, United States, 32504
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33677-4227
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0296
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Atlanta, Georgia, United States, 30342
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31405
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859-5000
United States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712
United States, Illinois
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Rush University Medical Center
Chicago, Illinois, United States, 60612
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9658
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60601
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Riley Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States, 46202-5225
St. Vincent Hospitals and Health Care Centers
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Kansas
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202-3830
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0284
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074-9308
Pediatric Specialty Clinic at Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-7223
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201-1595
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
Walter Reed Army Medical Center
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01107
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Floating Hospital for Children
Boston, Massachusetts, United States, 02111
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007-5364
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Hurley Medical Center
Flint, Michigan, United States, 48503
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0914
Van Elslander Cancer Center at St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073-6769
United States, Minnesota
Children's Hospitals and Clinics - Minneapolis/St. Paul
Minneapolis, Minnesota, United States, 55404
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
University of Missouri - Columbia
Columbia, Missouri, United States, 65203
United States, Nebraska
Children's Hospital of Omaha
Omaha, Nebraska, United States, 68114
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-2168
United States, Nevada
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112-2094
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Valerie Fund Children's Center at Atlantic Health
Summit, New Jersey, United States, 07901
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States, 11212
Comprehensive Cancer Center at Maimonides Medical Center
Brooklyn, New York, United States, 11219
Children's Hospital at Albany Medical Center
Albany, New York, United States, 12208
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201-5493
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11794-8174
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
New York Medical College
Valhalla, New York, United States, 10595
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Mount Sinai Medical Center
New York, New York, United States, 10029
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1081
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, United States, 27858-4354
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233
United States, North Dakota
Dakota Cancer Institute at Innovis Health - Dakota Clinic
Fargo, North Dakota, United States, 58103-4940
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308-1062
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404
Columbus Children's Hospital
Columbus, Ohio, United States, 43205-2696
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106-5065
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States, 44501
Toledo Children's Hospital
Toledo, Ohio, United States, 43601
United States, Oklahoma
Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Doernbecher Children's Hospital at Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States, 97227
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-1320
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States, 29605
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States, 29203
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105-1080
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37901
East Tennessee State University Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, United States, 37614-0622
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232-6310
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Center for Cancer Prevention and Care at Scott and White Clinic
Temple, Texas, United States, 76508
Children's Hospital of Austin
Austin, Texas, United States, 78701
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States, 78236
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
MBCCOP - South Texas Pediatrics
San Antonio, Texas, United States, 78229-3900
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
San Antonio, Texas, United States, 78229-3902
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-9063
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States, 79106
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05401-3498
United States, Virginia
Carilion Medical Center for Children at Roanoke Community Hospital
Roanoke, Virginia, United States, 24029
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507
INOVA Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0121
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-5100
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Deaconess Medical Center
Spokane, Washington, United States, 99210-0248
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Group Health Central Hospital
Seattle, Washington, United States, 98112
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-0001
Mary Bridge Children's Hospital and Health Center - Tacoma
Tacoma, Washington, United States, 98415-0299
United States, West Virginia
Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9300
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, United States, 25302
United States, Wisconsin
Bellin Memorial Hospital
Green Bay, Wisconsin, United States, 54301
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449-5772
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-9070
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Australia, New South Wales
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Royal Children's Hospital
Brisbane, Queensland, Australia, 4029
Australia, South Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Children's Hospital of Western Ontario
London, Ontario, Canada, N6C 2V5
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8S 4J9
Canada, Quebec
Centre de Recherche du Centre Hospitalier de l'Universite Laval
Sainte Foy, Quebec, Canada, GIV 4G2
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada, H3G 1A4
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
New Zealand
Starship Children's Health
Auckland, New Zealand
Puerto Rico
Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
San Jorge Children's Hospital
Santurce, Puerto Rico, 00912
Switzerland
Swiss Pediatric Oncology Group Lausanne
Lausanne, Switzerland, CH 1011
Swiss Pediatric Oncology Group Geneva
Geneva, Switzerland, CH 1211
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, CH 3010
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Kenneth J. Cohen, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069135, COG-ACNS0126
Study First Received: January 4, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00028795     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood brain stem glioma
childhood high-grade cerebral astrocytoma
childhood spinal cord neoplasm
untreated childhood brain stem glioma

Additional relevant MeSH terms:
Glioblastoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Central Nervous System Neoplasms
Temozolomide
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Antineoplastic Agents, Alkylating
Glioma
Neoplasms, Neuroepithelial
Alkylating Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009