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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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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