Spots Global Cancer Trial Database for Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma
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Trial Identification
Brief Title: Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma
Official Title: A Phase I/II Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma
Study ID: NCT00003573
Study Description
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 radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy followed by combination chemotherapy in treating children with newly diagnosed advanced medulloblastoma.
Detailed Description: OBJECTIVES: * Assess the response rate and toxicity of oral etoposide and radiotherapy in children with newly diagnosed high stage medulloblastoma. * Compare the response rate and toxicity of these patients to historical control patients registered on POG #9031. * Estimate the 2-year event-free survival and overall survival of these patients. * Evaluate the toxicity of dose intensive chemotherapy with oral etoposide, cisplatin, cyclophosphamide, and vincristine following craniospinal irradiation in these patients. OUTLINE: Patients begin treatment within 1 month of surgery. Patients receive 6 weeks of radiotherapy to the head and spine, with boosts to the posterior fossa and to sites of metastasis. Patients also receive 2 courses of oral etoposide once daily for 3 weeks concurrent with and immediately following radiotherapy (weeks 1-3 and 5-7). Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks for 3 courses beginning on week 11, oral etoposide daily for 21 days every 4 weeks for 3 courses (weeks 11, 15, and 19), cyclophosphamide IV on days 1 and 2 with filgrastim (G-CSF) SQ daily for at least 10 days every 4 weeks for 8 courses (weeks 23-51), and vincristine IV on days 1, 8, and 15 every 4 weeks for 8 courses (weeks 23-51). Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually thereafter. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within about 2 years.
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
MBCCOP - Gulf Coast, Mobile, Alabama, United States
Arizona Cancer Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
University of California San Diego Cancer Center, La Jolla, California, United States
Lucile Packard Children's Hospital at Stanford, Palo Alto, California, United States
Sutter Cancer Center, Sacramento, California, United States
University of California Davis Medical Center, Sacramento, California, 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
Naval Medical Center - San Diego, San Diego, California, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Shands Hospital and Clinics, University of Florida, Gainesville, Florida, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
Sylvester Cancer Center, University of Miami, Miami, Florida, United States
Miami Children's Hospital, Miami, Florida, United States
Walt Disney Memorial Cancer Institute, Orlando, Florida, United States
CCOP - Florida Pediatric, Tampa, Florida, United States
St. Mary's Hospital, West Palm Beach, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
Tripler Army Medical Center, Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
Children's Memorial Hospital, Chicago, Chicago, Illinois, United States
Hope Children's Hospital, Oak Lawn, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Regional Medical Center, Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Eastern Maine Medical Center, Bangor, Maine, United States
Maine Children's Cancer Program, Portland, Maine, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Boston Floating Hospital Infants and Children, Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
St. John's Hospital and Medical Center, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, United States
University of Missouri-Columbia Hospital and Clinics, Columbia, Missouri, United States
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
University of New Mexico School of Medicine, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Schneider Children's Hospital, New Hyde Park, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, 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
Carolinas Medical Center, Charlotte, North Carolina, United States
Presbyterian Healthcare, Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
East Carolina University School of Medicine, Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Oklahoma Memorial Hospital, Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma, United States
CCOP - Columbia River Program, Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center, Portland, Oregon, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, 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
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base, Texas, United States
MBCCOP - South Texas Pediatric, San Antonio, 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
Vermont Cancer Center, Burlington, Vermont, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Naval Medical Center, Portsmouth, Portsmouth, Virginia, United States
Massey Cancer Center, Richmond, Virginia, United States
Carilion Roanoke Community Hospital, Roanoke, Virginia, United States
Madigan Army Medical Center, Tacoma, Washington, United States
West Virginia University Medical School-Charleston, Charleston, West Virginia, United States
West Virginia University Hospitals, Morgantown, West Virginia, United States
St. Vincent Hospital, Green Bay, Wisconsin, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Alberta Children's Hospital, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Children's Hospital, Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
McGill University Health Center - Montreal Children's Hospital, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Centre Hospitalier de L'Universite Laval, Sainte Foy, Quebec, Canada
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
San Jorge Childrens Hospital, Santurce, , Puerto Rico
Swiss Pediatric Oncology Group Bern, Bern, , Switzerland
Clinique de Pediatrie, Geneva, , Switzerland
Contact Details
Name: Albert Moghrabi, MD
Affiliation: Hopital Sainte Justine
Role: STUDY_CHAIR
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