Spots Global Cancer Trial Database for Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
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Trial Identification
Brief Title: Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
Official Title: Dose-Intensive Melphalan and Cyclophosphamide With Autologous Bone Marrow Rescue for Recurrent Medulloblastoma and Germ Cell Tumors
Study ID: NCT00002594
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so that they stop growing or die. bone marrow transplantation and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow transplantation and/or peripheral stem cell transplantation in treating patients who have recurrent medulloblastoma or CNS germ cell tumors.
Detailed Description: OBJECTIVES: * Determine the response and progression-free survival in patients with recurrent medulloblastoma or CNS germ cell tumors treated with intensive melphalan and cyclophosphamide followed by autologous bone marrow and/or peripheral blood stem cell rescue. * Determine the acute and delayed toxic effects of this regimen in these patients. OUTLINE: Autologous bone marrow and/or peripheral blood stem cells (PBSC) are harvested. Patients then receive intensive cyclophosphamide IV over 1 hour on days -8 to -5 and melphalan IV over 15 minutes on days -4 to -2. Bone marrow is reinfused on day 0. PBSC are reinfused on day 0 if used alone or on day 1 if used after autologous bone marrow transplantation (ABMT). Sargramostim (GM-CSF) is administered IV over 2 hours daily beginning 4 hours after ABMT and continuing until blood counts recover. Patients are followed every 6 months through year 4 and then annually thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2.5 years.
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
University of South Alabama Medical Center, Mobile, Alabama, United States
Arizona Cancer Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
Sutter Cancer Center, Sacramento, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego, California, United States
Children's Hospital San Diego, San Diego, California, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
Stanford University Medical Center, Stanford, California, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Broward General Medical Center, Fort Lauderdale, Florida, United States
Children's Hospital of Southwest Florida, Fort Myers, Florida, United States
Shands Hospital and Clinics, University of Florida, Gainesville, Florida, United States
Joe DiMaggio Children's Hospital at Memorial, Hollywood, 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
Baptist Hospital of Miami, Miami, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Nemours Children's Clinic-Orlando, Orlando, Florida, United States
Sacred Heart Children's Hospital, Pensacola, Florida, United States
All Children's Hospital, St. Petersburg, Florida, United States
Tampa Children's Hospital, Tampa, Florida, United States
St. Mary's Hospital, West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Scottish Rite, 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
Advocate 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
Wesley 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
Children's Hospital of New Orleans, New Orleans, Louisiana, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Eastern Maine Medical Center, Bangor, Maine, United States
Maine Children's Cancer Program, Scarborough, Maine, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Floating Hospital for Children, Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
St. John 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 Medical Center, Saint Louis, Missouri, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center, 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
Beth Israel Hospital North, New York, New York, United States
James P. Wilmot 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 St. 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
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Warren Clinic, Tulsa, Oklahoma, United States
Legacy Emanuel Hospital and Health Center, Portland, Oregon, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Children's Hospital of Greenville Hospital System, Greenville, South Carolina, United States
East Tennessee State University Cancer Center at JCMC, Johnson City, Tennessee, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Driscoll Children's Hospital, Corpus Christi, Texas, 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
Texas Children's Cancer Center, Houston, 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
Scott and White Memorial Hospital, Temple, Texas, United States
Vermont Cancer Center, Burlington, Vermont, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, 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 Medical Center for Children, Roanoke, Virginia, United States
Madigan Army Medical Center, Tacoma, Washington, 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
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Children's Hospital at Westmead, Westmead, New South Wales, Australia
Royal Children's Hospital, Brisbane, Queensland, Australia
Royal Children's Hospital, Parkville, Victoria, Australia
Alberta Children's Hospital, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Chedoke-McMaster Hospitals, 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 de Recherche du 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
Swiss Pediatric Oncology Group Geneva, Geneva, , Switzerland
Contact Details
Name: Donald H. Mahoney, MD
Affiliation: Texas Children's Cancer Center
Role: STUDY_CHAIR
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