DOSE-INTENSIVE MELPHALAN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS BONE MARROW RESCUE FOR RECURRENT MEDULLOBLASTOMA AND GERM CELL TUMORS - A PEDIATRIC ONCOLOGY GROUP PILOT STUDY
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Donald H. Mahoney, MD
Study Chair
Texas Children's Cancer Center
United States: Federal Government
CDR0000063784
NCT00002594
September 1994
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Stanford University Medical Center | Stanford, California 94305-5408 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
| Shands Hospital and Clinics, University of Florida | Gainesville, Florida 32610-100277 |
| Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
| Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| Children's Hospital of Michigan | Detroit, Michigan 48201 |
| Hurley Medical Center | Flint, Michigan 48503 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| Presbyterian Healthcare | Charlotte, North Carolina 28233-3549 |
| East Carolina University School of Medicine | Greenville, North Carolina 27858-4354 |
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| Medical City Dallas Hospital | Dallas, Texas 75230 |
| San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base, Texas 78236-5300 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Vermont Cancer Center | Burlington, Vermont 05401-3498 |
| Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| State University of New York - Upstate Medical University | Syracuse, New York 13210 |
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
| Baptist Hospital of Miami | Miami, Florida 33176-2197 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Naval Medical Center, Portsmouth | Portsmouth, Virginia 23708-2197 |
| Massey Cancer Center | Richmond, Virginia 23298-0037 |
| St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| Sutter Cancer Center | Sacramento, California 95816 |
| Eastern Maine Medical Center | Bangor, Maine 04401 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| University of South Alabama Medical Center | Mobile, Alabama 36604 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego, California 92120 |
| Children's Hospital San Diego | San Diego, California 92123-4282 |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara, California 95051-5386 |
| Broward General Medical Center | Fort Lauderdale, Florida 33316 |
| Children's Hospital of Southwest Florida | Fort Myers, Florida 33908 |
| Joe DiMaggio Children's Hospital at Memorial | Hollywood, Florida 33021 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| Miami Children's Hospital | Miami, Florida 33155-4069 |
| Florida Hospital Cancer Institute | Orlando, Florida 32804 |
| Nemours Children's Clinic-Orlando | Orlando, Florida 32806 |
| Sacred Heart Children's Hospital | Pensacola, Florida 32504 |
| All Children's Hospital | St. Petersburg, Florida 33701 |
| Tampa Children's Hospital | Tampa, Florida 33677-4227 |
| St. Mary's Hospital | West Palm Beach, Florida 33407 |
| Children's Healthcare of Atlanta - Scottish Rite | Atlanta, Georgia 30342 |
| Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
| Advocate Hope Children's Hospital | Oak Lawn, Illinois 60453 |
| Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
| Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Wesley Medical Center | Wichita, Kansas 67214 |
| Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
| Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
| Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Floating Hospital for Children | Boston, Massachusetts 02111 |
| University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
| St. John Hospital and Medical Center | Detroit, Michigan 48236 |
| University of Missouri-Columbia Hospital and Clinics | Columbia, Missouri 65212 |
| Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
| Washington University Medical Center | Saint Louis, Missouri 63105 |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
| Schneider Children's Hospital | New Hyde Park, New York 11042 |
| Beth Israel Hospital North | New York, New York 10128 |
| James P. Wilmot Cancer Center | Rochester, New York 14642 |
| Mission St. Joseph's Health System | Asheville, North Carolina 28801 |
| Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
| Warren Clinic | Tulsa, Oklahoma 74136 |
| Legacy Emanuel Hospital and Health Center | Portland, Oregon 97227 |
| St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
| Children's Hospital of Greenville Hospital System | Greenville, South Carolina 29605 |
| East Tennessee State University Cancer Center at JCMC | Johnson City, Tennessee 37604 |
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
| Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
| Texas Children's Cancer Center | Houston, Texas 77030-2399 |
| Scott and White Memorial Hospital | Temple, Texas 76508 |
| Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
| Carilion Medical Center for Children | Roanoke, Virginia 24029 |
| West Virginia University - Charleston | Charleston, West Virginia 25302 |
| West Virginia University Hospitals | Morgantown, West Virginia 26506-9300 |