Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
- Conditions
- Central Nervous System TumorsBrain Tumors
- Interventions
- Registration Number
- NCT00003935
- 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 drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vincristine plus etoposide and radiation therapy in treating children who have newly diagnosed brain stem glioma.
- Detailed Description
OBJECTIVES: I. Evaluate the efficacy of vincristine plus etoposide with concurrent radiotherapy on one year survival in children with newly diagnosed diffuse intrinsic brain stem glioma. II. Assess the toxicity of this regimen in this patient population.
OUTLINE: Induction: Patients receive oral etoposide daily on days 1-21 and vincristine IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiotherapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One week after induction therapy, patients receive vincristine IV on days 1 and 8 and oral etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment vincristine sulfate Induction: Patients receive oral etoposide daily on days 1-21 and vincristine sulfate IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiation therapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One week after induction therapy, patients receive vincristine sulfate IV on days 1 and 8 and oral etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter Treatment radiation therapy Induction: Patients receive oral etoposide daily on days 1-21 and vincristine sulfate IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiation therapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One week after induction therapy, patients receive vincristine sulfate IV on days 1 and 8 and oral etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter Treatment etoposide Induction: Patients receive oral etoposide daily on days 1-21 and vincristine sulfate IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiation therapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One week after induction therapy, patients receive vincristine sulfate IV on days 1 and 8 and oral etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter
- Primary Outcome Measures
Name Time Method Survival 1 year
- Secondary Outcome Measures
Name Time Method Monitor the toxicity
Related Research Topics
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Trial Locations
- Locations (110)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Kaiser Permanente Medical Center - Santa Clara
🇺🇸Santa Clara, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Children's Memorial Hospital, Chicago
🇺🇸Chicago, Illinois, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
Hope Children's Hospital
🇺🇸Oak Lawn, Illinois, United States
Boston Floating Hospital Infants and Children
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
St. Mary's Hospital
🇺🇸West Palm Beach, Florida, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
McGill University Health Center - Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
University of New Mexico School of Medicine
🇺🇸Albuquerque, New Mexico, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Swiss Pediatric Oncology Group Bern
🇨ðŸ‡Bern, Switzerland
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier de L'Universite Laval
🇨🇦Sainte Foy, Quebec, Canada
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
University of Missouri-Columbia Hospital and Clinics
🇺🇸Columbia, Missouri, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Kaiser Permanente-Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Children's Hospital and Health Center
🇺🇸San Diego, California, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Oklahoma Memorial Hospital
🇺🇸Oklahoma City, Oklahoma, United States
St. John's Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Children's Hospital
🇨🇦Hamilton, Ontario, Canada
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
CCOP - Florida Pediatric
🇺🇸Tampa, Florida, United States
Legacy Emanuel Hospital and Health Center
🇺🇸Portland, Oregon, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Presbyterian Healthcare
🇺🇸Charlotte, North Carolina, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Natalie Warren Bryant Cancer Center
🇺🇸Tulsa, Oklahoma, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
🇺🇸Lackland Air Force Base, Texas, United States
Saint Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Texas Oncology P.A.
🇺🇸Dallas, Texas, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Scott and White Clinic
🇺🇸Temple, Texas, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Carilion Roanoke Community Hospital
🇺🇸Roanoke, Virginia, United States
West Virginia University Medical School-Charleston
🇺🇸Charleston, West Virginia, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Saint Jude Midwest Affiliate
🇺🇸Peoria, Illinois, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Maine Children's Cancer Program
🇺🇸Portland, Maine, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Mission Saint Joseph's Health System
🇺🇸Asheville, North Carolina, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
James H. Quillen College of Medicine
🇺🇸Johnson City, Tennessee, United States
MBCCOP - South Texas Pediatric
🇺🇸San Antonio, Texas, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
San Jorge Childrens Hospital
🇵🇷Santurce, Puerto Rico
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Walt Disney Memorial Cancer Institute
🇺🇸Orlando, Florida, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Clinique de Pediatrie
🇨ðŸ‡Geneva, Switzerland
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Shands Hospital and Clinics, University of Florida
🇺🇸Gainesville, Florida, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States