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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002594 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: sargramostim Drug: cyclophosphamide Drug: melphalan Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | DOSE-INTENSIVE MELPHALAN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS BONE MARROW RESCUE FOR RECURRENT MEDULLOBLASTOMA AND GERM CELL TUMORS - A PEDIATRIC ONCOLOGY GROUP PILOT STUDY |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 1994 |
OBJECTIVES:
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| Ages Eligible for Study: | 2 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of recurrent medulloblastoma or CNS germ cell tumor
Histologic review of the primary intracranial or spinal cord tumor required
No more than 1 prior primary therapy (radiotherapy or chemoradiotherapy) and/or 1 prior salvage therapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35233 | |
| University of South Alabama Medical Center | |
| Mobile, Alabama, United States, 36604 | |
| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Children's Hospital San Diego | |
| San Diego, California, United States, 92123-4282 | |
| Kaiser Permanente Medical Center - Santa Clara | |
| Santa Clara, California, United States, 95051-5386 | |
| Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | |
| San Diego, California, United States, 92120 | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5208 | |
| Sutter Cancer Center | |
| Sacramento, California, United States, 95816 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Florida | |
| All Children's Hospital | |
| St. Petersburg, Florida, United States, 33701 | |
| Baptist Hospital of Miami | |
| Miami, Florida, United States, 33176-2197 | |
| Broward General Medical Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Children's Hospital of Southwest Florida | |
| Fort Myers, Florida, United States, 33908 | |
| Florida Hospital Cancer Institute | |
| Orlando, Florida, United States, 32804 | |
| Nemours Children's Clinic-Orlando | |
| Orlando, Florida, United States, 32806 | |
| Miami Children's Hospital | |
| Miami, Florida, United States, 33155-4069 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Joe DiMaggio Children's Hospital at Memorial | |
| Hollywood, Florida, United States, 33021 | |
| Sacred Heart Children's Hospital | |
| Pensacola, Florida, United States, 32504 | |
| Shands Hospital and Clinics, University of Florida | |
| Gainesville, Florida, United States, 32610-100277 | |
| St. Mary's Hospital | |
| West Palm Beach, Florida, United States, 33407 | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| Tampa Children's Hospital | |
| Tampa, Florida, United States, 33677-4227 | |
| United States, Georgia | |
| Children's Healthcare of Atlanta - Scottish Rite | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| Tripler Army Medical Center | |
| Honolulu, Hawaii, United States, 96859-5000 | |
| United States, Illinois | |
| Advocate Hope Children's Hospital | |
| Oak Lawn, Illinois, United States, 60453 | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| Rush-Presbyterian-St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Saint Jude Midwest Affiliate | |
| Peoria, Illinois, United States, 61637 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Wesley Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| Children's Hospital of New Orleans | |
| New Orleans, Louisiana, United States, 70118 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Eastern Maine Medical Center | |
| Bangor, Maine, United States, 04401 | |
| Maine Children's Cancer Program | |
| Scarborough, Maine, United States, 04074-9308 | |
| United States, Maryland | |
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | |
| Baltimore, Maryland, United States, 21201-1595 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Floating Hospital for Children | |
| Boston, Massachusetts, United States, 02111 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| University of Massachusetts Memorial Medical Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Children's Hospital of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| St. John Hospital and Medical Center | |
| Detroit, Michigan, United States, 48236 | |
| United States, Mississippi | |
| Keesler Medical Center - Keesler AFB | |
| Keesler AFB, Mississippi, United States, 39534-2511 | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Cardinal Glennon Children's Hospital | |
| Saint Louis, Missouri, United States, 63104 | |
| University of Missouri-Columbia Hospital and Clinics | |
| Columbia, Missouri, United States, 65212 | |
| Washington University Medical Center | |
| Saint Louis, Missouri, United States, 63105 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New Mexico | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Beth Israel Hospital North | |
| New York, New York, United States, 10128 | |
| James P. Wilmot Cancer Center | |
| Rochester, New York, United States, 14642 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11042 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| State University of New York Health Sciences Center - Stony Brook | |
| Stony Brook, New York, United States, 11790-7775 | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1081 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Presbyterian Healthcare | |
| Charlotte, North Carolina, United States, 28233 | |
| Mission St. Joseph's Health System | |
| Asheville, North Carolina, United States, 28801 | |
| East Carolina University School of Medicine | |
| Greenville, North Carolina, United States, 27858-4354 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Warren Clinic | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Legacy Emanuel Hospital and Health Center | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| St. Christopher's Hospital for Children | |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02818 | |
| United States, South Carolina | |
| Children's Hospital of Greenville Hospital System | |
| Greenville, South Carolina, United States, 29605 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Tennessee | |
| East Tennessee State University Cancer Center at JCMC | |
| Johnson City, Tennessee, United States, 37604 | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| United States, Texas | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| Driscoll Children's Hospital | |
| Corpus Christi, Texas, United States, 78466 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| Scott and White Memorial Hospital | |
| Temple, Texas, United States, 76508 | |
| San Antonio Military Pediatric Cancer and Blood Disorders Center | |
| Lackland Air Force Base, Texas, United States, 78236 | |
| Texas Children's Cancer Center | |
| Houston, Texas, United States, 77030-2399 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78207 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0361 | |
| United States, Vermont | |
| Vermont Cancer Center | |
| Burlington, Vermont, United States, 05401-3498 | |
| United States, Virginia | |
| Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Carilion Medical Center for Children | |
| Roanoke, Virginia, United States, 24029 | |
| Inova Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042-3300 | |
| Cancer Center at the University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Naval Medical Center, Portsmouth | |
| Portsmouth, Virginia, United States, 23708-5100 | |
| United States, Washington | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431-5000 | |
| United States, West Virginia | |
| West Virginia University - Charleston | |
| Charleston, West Virginia, United States, 25302 | |
| West Virginia University Hospitals | |
| Morgantown, West Virginia, United States, 26506-9300 | |
| United States, Wisconsin | |
| Midwest Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54307-9070 | |
| Australia, New South Wales | |
| Children's Hospital at Westmead | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Royal Children's Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Australia, Victoria | |
| Royal Children's Hospital | |
| Parkville, Victoria, Australia, 3052 | |
| Canada, Alberta | |
| Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T2T 5C7 | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Children's Hospital of Eastern Ontario | |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Chedoke-McMaster Hospitals | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Canada, Quebec | |
| Centre de Recherche du Centre Hospitalier de l'Universite Laval | |
| Sainte Foy, Quebec, Canada, GIV 4G2 | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| McGill University Health Center - Montreal Children's Hospital | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Netherlands | |
| Academisch Ziekenhuis Groningen | |
| Groningen, Netherlands, 9700 RB | |
| Puerto Rico | |
| San Jorge Childrens Hospital | |
| Santurce, Puerto Rico, 00912 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | |
| Bern, Switzerland, CH 3010 | |
| Swiss Pediatric Oncology Group Geneva | |
| Geneva, Switzerland, CH 1211 | |
| Study Chair: | Donald H. Mahoney, MD | Texas Children's Cancer Center |
More Information
| Study ID Numbers: | CDR0000063784, COG-P9430, POG-9430 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002594 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood brain tumor childhood central nervous system germ cell tumor recurrent childhood medulloblastoma |
|
Melphalan Neuroectodermal Tumors, Primitive Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Cyclophosphamide Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Glioma Alkylating Agents |
Nervous System Neoplasms Neoplasms by Histologic Type Nervous System Diseases Immunosuppressive Agents Pharmacologic Actions Neuroectodermal Tumors Neoplasms Myeloablative Agonists Medulloblastoma Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Neoplasms, Glandular and Epithelial |