Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma
- Conditions
- Brain TumorCentral Nervous System Tumor
- Interventions
- Registration Number
- NCT00006024
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of temozolomide plus lomustine followed by radiation therapy in treating patients who have high-grade malignant glioma.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose of temozolomide when administered with lomustine in patients with high-grade malignant gliomas.
* Determine the dose-limiting toxic effects of this regimen in these patients.
* Evaluate the feasibility of radiotherapy after this treatment regimen in this patient population.
* Evaluate the radiographic responses in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of temozolomide.
Patients receive oral temozolomide on days 1-5 and oral lomustine on day 1. Treatment continues every 28 days, if blood counts have recovered, for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo radiotherapy on days 1-5 weekly for 6 weeks. Patients continue the same chemotherapy regimen for up to 6 more courses beginning 4 weeks after completion of radiotherapy.
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pre and Post radiation Chemotherapy temozolomide - Pre and Post radiation Chemotherapy lomustine -
- Primary Outcome Measures
Name Time Method Progression Free Survival Length of study This trial is a phase I evaluation of temozolomide in combination with a fixed dose of CCNU with the starting dose for temozolomide
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (234)
Children's Hospital of Columbus
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Swiss Pediatric Oncology Group Lausanne
🇨🇭Lausanne, Switzerland
Floating Hospital for Children
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Children's Hospitals and Clinics - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Children's Hospital of Oakland
🇺🇸Oakland, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
🇺🇸San Diego, California, United States
Sacred Heart Children's Hospital
🇺🇸Pensacola, Florida, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Alfred I. Dupont Institute
🇺🇸Wilmington, Delaware, United States
Memorial Health University Medical Center, Inc.
🇺🇸Savannah, Georgia, United States
Children's Healthcare of Atlanta - Scottish Rite
🇺🇸Atlanta, Georgia, United States
Children's Hospital of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Jonathan Jaques Children's Cancer Center
🇺🇸Long Beach, California, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
University of Miami-Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Kaiser Permanente Medical Center - Santa Clara
🇺🇸Santa Clara, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
St. Vincent Hospital and Health Care Center
🇺🇸Indianapolis, Indiana, United States
Saint Jude Midwest Affiliate
🇺🇸Peoria, Illinois, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Medical College of Georgia Comprehensive Cancer Center
🇺🇸Augusta, Georgia, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Atlantic Health System
🇺🇸Summit, New Jersey, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Brooklyn Hospital Center
🇺🇸Brooklyn, New York, United States
Sunrise Hospital and Medical Center
🇺🇸Las Vegas, Nevada, United States
James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
State University of New York Health Science Center at Brooklyn College of Medicine
🇺🇸Brooklyn, New York, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
St. Mary's/Duluth Clinic Cancer Center
🇺🇸Duluth, Minnesota, United States
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States
Children's Hospital Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Children's Hospitals and Clinics of Minnesota
🇺🇸Saint Paul, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Dakota Cancer Institute
🇺🇸Fargo, North Dakota, United States
Natalie Warren Bryant Cancer Center
🇺🇸Tulsa, Oklahoma, United States
Forum Health-Tod Childrens Hospital
🇺🇸Youngstown, Ohio, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
Brookdale University Hospital and Medical Center
🇺🇸Brooklyn, New York, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Presbyterian Healthcare
🇺🇸Charlotte, North Carolina, United States
Toledo Children's Hospital
🇺🇸Toledo, Ohio, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Swiss Pediatric Oncology Group Geneva
🇨🇭Geneva, Switzerland
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Children's Hospital of Western Ontario
🇨🇦London, Ontario, Canada
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
McGill University Health Center - Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Children's Hospital
🇨🇦Hamilton, Ontario, Canada
Starship Children's Hospital
🇳🇿Auckland, New Zealand
Janeway Children's Health and Rehabilitation Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Women's and Children's Hospital
🇦🇺North Adelaide, South Australia, Australia
Centre Hospitalier de L'Universite Laval
🇨🇦Sainte Foy, Quebec, Canada
San Jorge Childrens Hospital
🇵🇷Santurce, Puerto Rico
Swiss Pediatric Oncology Group Bern
🇨🇭Bern, Switzerland
Laval University Medical Center
🇨🇦Sainte-Foy, Quebec, Canada
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Sydney Children's Hospital
🇦🇺Randwick, New South Wales, Australia
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
Kaiser Permanente Medical Center - San Francisco Geary Campus
🇺🇸San Francisco, California, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
New York Medical College
🇺🇸Valhalla, New York, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Presbyterian-St Luke's Medical Center
🇺🇸Denver, Colorado, United States
Children's Hospital of Denver
🇺🇸Denver, Colorado, United States
Childhood Hematology/Oncology Associates
🇺🇸Denver, Colorado, United States
Doernbecher Children's Hospital
🇺🇸Portland, Oregon, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Tampa Children's Hospital
🇺🇸Tampa, Florida, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Children's Hospital San Diego
🇺🇸San Diego, California, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Joe DiMaggio Children's Hospital at Memorial
🇺🇸Hollywood, Florida, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
St. Mary's Hospital
🇺🇸West Palm Beach, Florida, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Hope Children's Hospital
🇺🇸Oak Lawn, Illinois, United States
Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Spectrum Health and DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
Children's Hospital of Omaha
🇺🇸Omaha, Nebraska, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Columbia Presbyterian Hospital
🇺🇸New York, New York, United States
Mission Saint Joseph's Health System
🇺🇸Asheville, North Carolina, United States
Children's Hospital of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Palmetto Health South Carolina Cancer Center
🇺🇸Columbia, South Carolina, United States
Legacy Emanuel Hospital and Health Center
🇺🇸Portland, Oregon, United States
Children's Hospital of Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Sioux Valley Hospital
🇺🇸Sioux Falls, South Dakota, United States
East Tennessee State University Cancer Center at JCMC
🇺🇸Johnson City, Tennessee, United States
Saint Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Texas Tech University Health Sciences Center School of Medicine
🇺🇸Amarillo, Texas, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Covenant Children's Hospital
🇺🇸Lubbock, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
🇺🇸Lackland Air Force Base, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Methodist Health Care System
🇺🇸San Antonio, Texas, United States
Scott and White Memorial Hospital
🇺🇸Temple, Texas, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
Carilion Medical Center for Children
🇺🇸Roanoke, Virginia, United States
Group Health Cooperative
🇺🇸Seattle, Washington, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Bellin Memorial Hospital
🇺🇸Green Bay, Wisconsin, United States
Mary Bridge Children's Health Center
🇺🇸Tacoma, Washington, United States
Cabell-Huntington Hospital, Inc
🇺🇸Huntington, West Virginia, United States
West Virginia University - Charleston
🇺🇸Charleston, West Virginia, United States
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Medical Center of Central Georgia
🇺🇸Macon, Georgia, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Nemours Children's Clinic-Orlando
🇺🇸Orlando, Florida, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, United States
Shands Hospital and Clinics, University of Florida
🇺🇸Gainesville, Florida, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Children's Hospital of Austin
🇺🇸Austin, Texas, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Raymond Blank Memorial Hospital for Children
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States