Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma
Brain Tumor, Central Nervous System Tumor
About this trial
This is an interventional treatment trial for Brain Tumor focused on measuring childhood high-grade cerebral astrocytoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed high-grade malignant glioma of one of the following subtypes: Glioblastoma Anaplastic astrocytoma Anaplastic oligoastrocytoma Gliomatosis cerebri No disseminated disease or primary spinal cord malignancies Measurable intracranial residual disease by MRI PATIENT CHARACTERISTICS: Age: 3 and over Under 22 at time of diagnosis Performance status: Karnofsky 50-100% if over 10 years of age Lansky 50-100% if 10 years of age or under Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 (transfusion independent) Hemoglobin at least 8.0 g/dL (RBC transfusions allowed) Hepatic: Bilirubin no greater than 1.5 times normal for age SGPT no greater than 2.5 times normal for age Albumin at least 2 g/dL Renal: Creatinine no greater than 1.5 times normal for age OR Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal for age Pulmonary: No dyspnea at rest No exercise intolerance Pulse oximetry at least 94% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy No concurrent prophylactic hematopoietic growth factors Chemotherapy: No prior chemotherapy Endocrine therapy: Prior corticosteroid therapy allowed No concurrent corticosteroids as antiemetic Radiotherapy: No prior radiotherapy Surgery: No more than 31 days since prior maximal neurosurgical procedure Other: No concurrent phenobarbital or cimetidine
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- University of South Alabama Medical Center
- Phoenix Children's Hospital
- Arizona Cancer Center
- University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- City of Hope Comprehensive Cancer Center
- Rebecca and John Moores UCSD Cancer Center
- Loma Linda University Medical Center
- Jonathan Jaques Children's Cancer Center
- Children's Hospital Los Angeles
- Cedars-Sinai Medical Center
- Jonsson Comprehensive Cancer Center, UCLA
- Children's Hospital Central California
- Children's Hospital of Oakland
- Chao Family Comprehensive Cancer Center
- Children's Hospital of Orange County
- Lucile Packard Children's Hospital at Stanford
- Sutter Cancer Center
- University of California Davis Medical Center
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
- Children's Hospital San Diego
- Kaiser Permanente Medical Center - San Francisco Geary Campus
- UCSF Comprehensive Cancer Center
- Santa Barbara Cottage Hospital
- Kaiser Permanente Medical Center - Santa Clara
- David Grant Medical Center
- Children's Hospital of Denver
- Childhood Hematology/Oncology Associates
- Presbyterian-St Luke's Medical Center
- University of Connecticut Health Center
- Yale Comprehensive Cancer Center
- Alfred I. Dupont Institute
- Lombardi Cancer Center
- Children's National Medical Center
- Walter Reed Army Medical Center
- Broward General Medical Center
- Children's Hospital of Southwest Florida
- Shands Hospital and Clinics, University of Florida
- Joe DiMaggio Children's Hospital at Memorial
- Nemours Children's Clinic
- University of Miami-Jackson Memorial Hospital
- Miami Children's Hospital
- Baptist Hospital of Miami
- Florida Hospital Cancer Institute
- Nemours Children's Clinic-Orlando
- Sacred Heart Children's Hospital
- All Children's Hospital
- Tampa Children's Hospital
- St. Mary's Hospital
- Emory University Hospital - Atlanta
- Children's Healthcare of Atlanta - Scottish Rite
- Medical College of Georgia Comprehensive Cancer Center
- Medical Center of Central Georgia
- Memorial Health University Medical Center, Inc.
- Cancer Research Center of Hawaii
- MBCCOP - Hawaii
- Tripler Army Medical Center
- Mountain States Tumor Institute
- University of Chicago Cancer Research Center
- Rush-Presbyterian-St. Luke's Medical Center
- University of Illinois at Chicago
- Children's Memorial Hospital - Chicago
- Hope Children's Hospital
- Lutheran General Hospital
- Saint Jude Midwest Affiliate
- Southern Illinois University School of Medicine
- Indiana University Cancer Center
- St. Vincent Hospital and Health Care Center
- Raymond Blank Memorial Hospital for Children
- John Stoddard Cancer Center
- Holden Comprehensive Cancer Center
- Wesley Medical Center
- Albert B. Chandler Medical Center, University of Kentucky
- Kosair Children's Hospital
- Tulane University School of Medicine
- Children's Hospital of New Orleans
- Ochsner Clinic
- Eastern Maine Medical Center
- Maine Children's Cancer Program
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
- Sinai Hospital of Baltimore
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Floating Hospital for Children
- Dana-Farber Cancer Institute
- Baystate Medical Center
- University of Massachusetts Memorial Medical Center - University Campus
- Mott Children's Hospital
- Children's Hospital of Michigan
- Henry Ford Hospital
- St. John Hospital and Medical Center
- Michigan State University
- Hurley Medical Center
- Spectrum Health and DeVos Children's Hospital
- Bronson Methodist Hospital
- CCOP - Beaumont
- William Beaumont Hospital
- St. Mary's/Duluth Clinic Cancer Center
- Children's Hospitals and Clinics - Minneapolis
- Mayo Clinic Cancer Center
- Children's Hospitals and Clinics of Minnesota
- University of Mississippi Medical Center
- Children's Mercy Hospital
- Cardinal Glennon Children's Hospital
- St. Louis Children's Hospital
- Children's Hospital of Omaha
- University of Nebraska Medical Center
- Sunrise Hospital and Medical Center
- Norris Cotton Cancer Center
- Hackensack University Medical Center
- Cancer Institute of New Jersey
- Newark Beth Israel Medical Center
- St. Joseph's Hospital and Medical Center
- Atlantic Health System
- University of New Mexico Cancer Research and Treatment Center
- Cancer Center of Albany Medical Center
- Albert Einstein Clinical Cancer Center
- Brooklyn Hospital Center
- State University of New York Health Science Center at Brooklyn College of Medicine
- Brookdale University Hospital and Medical Center
- Maimonides Medical Center
- Roswell Park Cancer Institute
- North Shore University Hospital
- Schneider Children's Hospital
- New York Presbyterian Hospital - Cornell Campus
- Memorial Sloan-Kettering Cancer Center
- Mount Sinai School of Medicine
- Columbia Presbyterian Hospital
- James P. Wilmot Cancer Center
- State University of New York Health Sciences Center - Stony Brook
- State University of New York - Upstate Medical University
- New York Medical College
- Mission Saint Joseph's Health System
- Lineberger Comprehensive Cancer Center, UNC
- Carolinas Medical Center
- Presbyterian Healthcare
- Duke Comprehensive Cancer Center
- East Carolina University School of Medicine
- Comprehensive Cancer Center at Wake Forest University
- Dakota Cancer Institute
- Children's Hospital Medical Center of Akron
- Children's Hospital Medical Center - Cincinnati
- Ireland Cancer Center
- Cleveland Clinic Taussig Cancer Center
- Children's Hospital of Columbus
- Children's Medical Center - Dayton
- Toledo Children's Hospital
- St. Vincent Mercy Medical Center
- Forum Health-Tod Childrens Hospital
- Children's Hospital of Oklahoma
- CCOP - Oklahoma
- Natalie Warren Bryant Cancer Center
- Doernbecher Children's Hospital
- Legacy Emanuel Hospital and Health Center
- Geisinger Medical Center
- Milton S. Hershey Medical Center
- Children's Hospital of Philadelphia
- St. Christopher's Hospital for Children
- Children's Hospital of Pittsburgh
- Rhode Island Hospital
- Medical University of South Carolina
- Palmetto Health South Carolina Cancer Center
- Children's Hospital of Greenville Hospital System
- Avera Cancer Institute
- Sioux Valley Hospital
- East Tennessee State University Cancer Center at JCMC
- East Tennessee Children's Hospital
- Saint Jude Children's Research Hospital
- Vanderbilt-Ingram Cancer Center
- Texas Tech University Health Sciences Center School of Medicine
- Children's Hospital of Austin
- Medical City Dallas Hospital
- Simmons Cancer Center - Dallas
- Cook Children's Medical Center - Fort Worth
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Baylor College of Medicine
- San Antonio Military Pediatric Cancer and Blood Disorders Center
- Covenant Children's Hospital
- University of Texas Health Science Center at San Antonio
- Methodist Health Care System
- Scott and White Memorial Hospital
- Huntsman Cancer Institute
- Vermont Cancer Center
- Cancer Center at the University of Virginia
- Inova Fairfax Hospital
- Children's Hospital of the King's Daughters
- Naval Medical Center, Portsmouth
- Massey Cancer Center
- Carilion Medical Center for Children
- Children's Hospital and Regional Medical Center - Seattle
- Fred Hutchinson Cancer Research Center
- Group Health Cooperative
- Deaconess Medical Center
- Mary Bridge Children's Health Center
- Madigan Army Medical Center
- West Virginia University - Charleston
- Cabell-Huntington Hospital, Inc
- West Virginia University Hospitals
- Bellin Memorial Hospital
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- St. Vincent Hospital
- Gundersen Lutheran Medical Center
- University of Wisconsin Hospital and Clinics
- Marshfield Clinic
- Midwest Children's Cancer Center
- Sydney Children's Hospital
- Children's Hospital at Westmead
- Royal Children's Hospital
- Women's and Children's Hospital
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- Cross Cancer Institute
- British Columbia Children's Hospital
- CancerCare Manitoba
- Janeway Children's Health and Rehabilitation Centre
- IWK Health Centre
- Children's Hospital
- Children's Hospital of Western Ontario
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- McGill University Health Center - Montreal Children's Hospital
- Hopital Sainte Justine
- Centre Hospitalier de L'Universite Laval
- Laval University Medical Center
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Academisch Ziekenhuis Groningen
- Starship Children's Hospital
- University of Puerto Rico School of Medicine Medical Sciences Campus
- San Jorge Childrens Hospital
- Swiss Pediatric Oncology Group Bern
- Swiss Pediatric Oncology Group Geneva
- Swiss Pediatric Oncology Group Lausanne
Arms of the Study
Arm 1
Experimental
Pre and Post radiation Chemotherapy