Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Children With Progressive Brain Tumors
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Trial Identification
Brief Title: Combination Chemotherapy in Treating Children With Progressive Brain Tumors
Official Title: Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old
Study ID: NCT00002944
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain.
Detailed Description: OBJECTIVES: * Compare the event free survival as a result of treatment with carboplatin and vincristine versus thioguanine, procarbazine, lomustine, and vincristine in children with progressive brain tumors. * Estimate tumor response rates to each regimen of chemotherapy in these patients. * Determine toxic effects and quality of life of children treated with each regimen of chemotherapy. * Investigate biological and clinical factors which may predict tumor response and early progression (tumor size, location, pathologic subtype, cytogenetics, and proliferative index by MIB-1 (Ki67)) in these patients. * Investigate factors contributing to neuropsychological and endocrine status of children with brain tumors treated without irradiation. OUTLINE: This is a randomized study. Patients are stratified according to site of disease, status at entry, and pathology. Patients are randomized to one of two treatment arms. Patients with neurofibromatosis are nonrandomly assigned to arm II. * Arm I: Patients receive induction with carboplatin and vincristine for 10 weeks followed by 2 weeks of rest. Induction is followed by 8 courses of maintenance beginning on day 84 of induction or upon hematopoietic recovery. Each course consists of 4 weekly doses of carboplatin and 3 weekly doses of vincristine (given concurrently with the first 3 weeks of carboplatin), followed by 2 weeks of rest. * Arm II: Patients receive oral thioguanine, procarbazine, and lomustine on days 0-4, followed by vincristine IV on days 14 and 28. Treatment continues every 6 weeks for a maximum of 8 courses. PROJECTED ACCRUAL: A total of 280-340 patients will be accrued over 4 years.
Eligibility
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Southern California Permanente Medical Group, Downey, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California, United States
Childrens Hospital Los Angeles, Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
Children's Hospital Central California, Madera, California, United States
Children's Hospital and Research Center Oakland, Oakland, California, United States
Children's Hospital of Orange County, Orange, California, United States
Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, United States
Sutter Cancer Center, Sacramento, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
Kaiser Permanente Medical Center - Oakland, Sacramento, California, United States
Rady Children's Hospital - San Diego, San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Santa Barbara Cottage Children's Hospital, Santa Barbara, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus, Santa Clara, California, United States
Children's Hospital Center for Cancer and Blood Disorders, Aurora, Colorado, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut, United States
Yale Cancer Center, New Haven, Connecticut, United States
Alfred I. duPont Hospital for Children, Wilmington, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
Children's National Medical Center, Washington, District of Columbia, United States
Broward General Medical Center Cancer Center, Fort Lauderdale, Florida, United States
Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
Miami Children's Hospital, Miami, Florida, United States
Baptist-South Miami Regional Cancer Program, Miami, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida, United States
M.D. Anderson Cancer Center at Orlando, Orlando, Florida, United States
Nemours Children's Clinic - Orlando, Orlando, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, United States
All Children's Hospital, Saint Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta, Georgia, United States
MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia, United States
Medical Center of Central Georgia, Macon, Georgia, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Keyser Family Cancer Center at Advocate Hope Children's Hospital, Oak Lawn, Illinois, United States
Advocate Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
Swedish-American Regional Cancer Center, Rockford, Illinois, United States
Simmons Cooper Cancer Institute, Springfield, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital, Indianapolis, Indiana, United States
Blank Children's Hospital, Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Wesley Medical Center, Wichita, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana, United States
Children's Hospital of New Orleans, New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans, Louisiana, United States
CancerCare of Maine at Eastern Maine Medical Center, Bangor, Maine, United States
Maine Children's Cancer Program at Barbara Bush Children's Hospital, Scarborough, Maine, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, United States
William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan, United States
CCOP - Duluth, Duluth, Minnesota, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Children's Hospitals and Clinics of Minnesota - St. Paul, St. Paul, Minnesota, United States
University of Mississippi Cancer Clinic, Jackson, Mississippi, United States
Keesler Air Force Base Medical Center, Keesler AFB, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital, St. Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St. Louis, Missouri, United States
Children's Hospital, Omaha, Nebraska, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, United States
St. Barnabas Medical Center Cancer Center, Livingston, New Jersey, United States
Overlook Hospital, Morristown, New Jersey, United States
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Albany Medical Center Hospital, Albany, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, United States
Maimonides Cancer Center at Maimonides Medical Center, Brooklyn, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital, Manhasset, New York, United States
Schneider Children's Hospital, New Hyde Park, New York, United States
Beth Israel Medical Center - Petrie Division, New York, New York, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division, New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
New York Medical College, Valhalla, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Dakota Cancer Institute at Dakota Clinic - South University, Fargo, North Dakota, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
Akron Children's Hospital, Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Dayton Children's - Dayton, Dayton, Ohio, United States
Toledo Hospital, Toledo, Ohio, United States
Medical University of Ohio Cancer Center, Toledo, Ohio, United States
Tod Children's Hospital, Youngstown, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon, United States
Knight Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Penn State Children's Hospital, Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
East Tennessee Children's Hospital, Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo, Texas, United States
Dell Children's Medical Center of Central Texas, Austin, Texas, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Wilford Hall Medical Center, Lackland AFB, Texas, United States
Covenant Children's Hospital, Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Primary Children's Medical Center, Salt Lake City, Utah, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia, United States
Naval Medical Center - Portsmouth, Portsmouth, Virginia, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
Carilion Medical Center for Children at Roanoke Community Hospital, Roanoke, Virginia, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Group Health Central Hospital, Seattle, Washington, United States
Deaconess Medical Center, Spokane, Washington, United States
Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, United States
Mary Bridge Children's Hospital and Health Center - Tacoma, Tacoma, Washington, United States
Madigan Army Medical Center - Tacoma, Tacoma, Washington, United States
West Virginia University Health Sciences Center - Charleston, Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington, West Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown, West Virginia, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
John Hunter Hospital, Newcastle, New South Wales, Australia
Prince of Wales Private Hospital, Randwick, New South Wales, Australia
Children's Hospital at Westmead, Westmead, New South Wales, Australia
Royal Children's Hospital, Brisbane, Queensland, Australia
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Alberta Children's Hospital, Calgary, Alberta, Canada
University of Alberta Hospital, Edmonton, Alberta, Canada
Children's & Women's Hospital of British Columbia, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Janeway Children's Health and Rehabilitation Centre, St. John's, Newfoundland and Labrador, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada
Children's Hospital of Western Ontario, London, Ontario, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Centre Hospitalier Universitaire de Quebec, Quebec, , Canada
University Medical Center Groningen, Groningen, , Netherlands
Starship Children's Health, Auckland, , New Zealand
Swiss Pediatric Oncology Group Bern, Bern, , Switzerland
Swiss Pediatric Oncology Group Geneva, Geneva, , Switzerland
Contact Details
Name: Joann Ater, MD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
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