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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004188 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation with treated peripheral stem cells following combination chemotherapy to see how well it works compared to peripheral stem cell transplantation with untreated peripheral stem cells following combination chemotherapy in treating patients with neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: isotretinoin Drug: melphalan Drug: topotecan hydrochloride Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma |
| Study Start Date: | February 2001 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed neuroblastoma OR ganglioneuroblastoma, and/or evidence of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, meeting 1 of the following criteria:
Age 12-18 months with stage IV disease meeting one of the following criteria:
At least 1 year old with the following:
Stage I, II, or IVS with disease progression to stage IV without interval chemotherapy
Less than 1 year old with the following:
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 | |
| Comprehensive Cancer Center at University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Phoenix Children's Hospital | |
| Phoenix, Arizona, United States, 85016-7710 | |
| United States, California | |
| Children's Hospital and Health Center - San Diego | |
| San Diego, California, United States, 92123-4282 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93638-8762 | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | |
| Long Beach, California, United States, 90801 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048-1865 | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90242-2814 | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| Kaiser Permanente Medical Center - Oakland | |
| Sacramento, California, United States, 95825 | |
| United States, Colorado | |
| Children's Hospital Cancer Center | |
| Denver, Colorado, United States, 80218-1088 | |
| United States, Connecticut | |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06360-2875 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Florida | |
| All Children's Hospital | |
| St. Petersburg, Florida, United States, 33701 | |
| Broward General Medical Center Cancer Center | |
| Ft. Lauderdale, Florida, United States, 33316 | |
| Kaplan Cancer Center at St. Mary's Medical Center | |
| West Palm Beach, Florida, United States, 33407 | |
| Lee Cancer Care of Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33901 | |
| Memorial Cancer Institute at Memorial Regional Hospital | |
| Hollywood, Florida, United States, 33021 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | |
| Tampa, Florida, United States, 33607 | |
| University of Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610-0232 | |
| United States, Illinois | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62794-9620 | |
| University of Illinois at Chicago Cancer Center | |
| Chicago, Illinois, United States, 60612-7243 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| St. Vincent Indianapolis Hospital | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| Blank Children's Hospital | |
| Des Moines, Iowa, United States, 50309 | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1083 | |
| United States, Kentucky | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40232 | |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536-0084 | |
| United States, Maine | |
| CancerCare of Maine at Eastern Maine Medial Center | |
| Bangor, Maine, United States, 04401 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Breslin Cancer Center at Ingham Regional Medical Center | |
| Lansing, Michigan, United States, 48910 | |
| C.S. Mott Children's Hospital at University of Michigan | |
| Ann Arbor, Michigan, United States, 48109-0238 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-5341 | |
| Spectrum Health Cancer Care - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503-2560 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| United States, Minnesota | |
| Children's Hospital of Minnesota - Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| Fairview University Medical Center - University Campus | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Children's Hospital of Omaha | |
| Omaha, Nebraska, United States, 68114-4113 | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| United States, Nevada | |
| Sunrise Hospital and Medical Center | |
| Las Vegas, Nevada, United States, 89109-2306 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Cancer Center at Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| St. Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| St. Joseph's Hospital and Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| United States, New Mexico | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| United States, New York | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Mission Hospitals - Memorial Campus | |
| Asheville, North Carolina, United States, 28801 | |
| Presbyterian Cancer Center at Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| United States, Ohio | |
| Children's Medical Center - Dayton | |
| Dayton, Ohio, United States, 45404-1815 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195-5217 | |
| Columbus Children's Hospital | |
| Columbus, Ohio, United States, 43205-2696 | |
| Medical College of Ohio Cancer Institute | |
| Toledo, Ohio, United States, 43614 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Palmetto Health South Carolina Cancer Center | |
| Columbia, South Carolina, United States, 29203 | |
| United States, South Dakota | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Tennessee | |
| East Tennessee Children's Hospital | |
| Knoxville, Tennessee, United States, 37916 | |
| United States, Texas | |
| Children's Hospital of Austin | |
| Austin, Texas, United States, 78701 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104-9958 | |
| Covenant Children's Hospital | |
| Lubbock, Texas, United States, 79410 | |
| Texas Tech University Health Sciences Center School of Medicine | |
| Amarillo, Texas, United States, 79106 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05405 | |
| United States, Virginia | |
| Carilion Cancer Center of Western Virginia | |
| Roanoke, Virginia, United States, 24029 | |
| Massey Cancer Center at Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298-0037 | |
| United States, Washington | |
| Providence Cancer Center at Sacred Heart Medical Center | |
| Spokane, Washington, United States, 99220-2555 | |
| United States, West Virginia | |
| Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | |
| Huntington, West Virginia, United States, 25701 | |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | |
| Morgantown, West Virginia, United States, 26506 | |
| United States, Wisconsin | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| Midwest Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Canada, Alberta | |
| Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T2T 5C7 | |
| Canada, British Columbia | |
| Children's & Women's Hospital of British Columbia | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Canada, Newfoundland and Labrador | |
| Janeway Children's Health and Rehabilitation Centre | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Ontario | |
| Children's Hospital of Eastern Ontario | |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Children's Hospital of Western Ontario | |
| London, Ontario, Canada, N6A 4G5 | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| McMaster Children's Hospital at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Canada, Quebec | |
| Centre Hospitalier Universitaire de Quebec | |
| Ste-Foy, Quebec, Canada, G1V 4G2 | |
| McGill Cancer Centre at McGill University | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre at Pasqua Hospital | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Study Chair: | Susan G. Kreissman, MD | Duke University |
More Information
| Study ID Numbers: | CDR0000067429, COG-A3973, CCG-A3973, POG-A3973, CCG-39703, FHCRC-1631.00 |
| Study First Received: | January 21, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004188 History of Changes |
| Health Authority: | United States: Federal Government |
|
localized resectable neuroblastoma regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma localized unresectable neuroblastoma |
|
Melphalan Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neuroblastoma Cisplatin Neoplasms, Germ Cell and Embryonal Therapeutic Uses Isotretinoin Dermatologic Agents |
Alkylating Agents Etoposide Neoplasms by Histologic Type Mitosis Modulators Vincristine Enzyme Inhibitors Antimitotic Agents Carboplatin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Tubulin Modulators |