|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003141 |
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 doctors to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Neuroblastoma Sarcoma |
Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: thiotepa Drug: vincristine sulfate Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors |
| Estimated Enrollment: | 83 |
| Study Start Date: | March 1998 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a pilot, multicenter study.
Patients undergo surgery for diagnosis and maximal tumor resection.
Within 6 weeks of surgery or when stable, patients begin induction chemotherapy comprising cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; cyclophosphamide IV over 1 hour on days 1-2; and etoposide IV over 1 hour on days 0-2. Twenty four hours after the last cyclophosphamide dose, patients receive filgrastim (G-CSF) subcutaneously (SC) and undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Within 6 weeks after induction chemotherapy, patients receive consolidation chemotherapy comprising carboplatin IV over 2 hours on days 0-1 followed immediately by escalating doses of thiotepa IV over 2 hours. Patients then undergo peripheral blood stem cell transplantation 48 hours after the last thiotepa dose. Patients receive G-CSF SC daily on days 3 to 21. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients experiencing dose-limiting toxicity due to thiotepa are removed from the study.
Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 3 years, and then annually for 3 years or until relapse.
PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | up to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven malignant brain or spinal cord tumor, including the following:
PATIENT CHARACTERISTICS:
Age:
Performance Status:
Life Expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Phoenix Children's Hospital | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | |
| Orange, California, United States, 92868 | |
| Children's Hospital and Research Center at Oakland | |
| Oakland, California, United States, 94609-1809 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93638-8762 | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027-0700 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Santa Barbara Cottage Hospital | |
| Santa Barbara, California, United States, 93102 | |
| David Grant Medical Center | |
| Travis Air Force Base, California, United States, 94535 | |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | |
| Long Beach, California, United States, 90801-1428 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Kaiser Permanente Medical Center - Sacramento | |
| Sacramento, California, United States, 95825 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90242 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| Children's Hospital of Denver | |
| Denver, Colorado, United States, 80218-1088 | |
| Presbyterian - St. Luke's Medical Center | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06360-7106 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| Lombardi Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Georgia | |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |
| Savannah, Georgia, United States, 31403-3089 | |
| MBCCOP-Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912-4000 | |
| Medical Center of Central Georgia | |
| Macon, Georgia, United States, 31201 | |
| United States, Idaho | |
| Mountain States Tumor Institute - Boise | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068-1174 | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62794-9658 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60601 | |
| University of Illinois Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Riley Children Cancer Center at Riley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202-5225 | |
| St. Vincent Hospitals and Health Care Centers | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| Blank Children's Hospital | |
| Des Moines, Iowa, United States, 50308 | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Kentucky | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40202-3830 | |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536-0284 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | |
| Baltimore, Maryland, United States, 21225 | |
| United States, Massachusetts | |
| Baystate Regional Cancer Program at Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, Michigan | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-5364 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0914 | |
| Spectrum Health and DeVos Children's Hospital | |
| Grand Rapids, Michigan, United States, 49503 | |
| Josephine Ford Cancer Center at Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| William Beaumont Hospital - Royal Oak | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| Children's Hospitals and Clinics - Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| Children's Hospitals and Clinics - Minnesota | |
| Saint Paul, Minnesota, United States, 55102 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Nebraska | |
| Children's Hospital of Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-2168 | |
| United States, Nevada | |
| Sunrise Hospital and Medical Center | |
| Las Vegas, Nevada, United States, 89119 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Robert Wood Johnson University Hospital | |
| New Brunswick, New Jersey, United States, 08903 | |
| St. Joseph's Hospital and Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| St. Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112-2094 | |
| Valerie Fund Children's Center at Atlantic Health | |
| Summit, New Jersey, United States, 07901 | |
| United States, New York | |
| Albert Einstein Clinical Cancer Center | |
| Bronx, New York, United States, 10461 | |
| Brookdale University Hospital and Medical Center | |
| Brooklyn, New York, United States, 11212 | |
| Brooklyn Hospital Center | |
| Brooklyn, New York, United States, 11201-5493 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Comprehensive Cancer Center at Maimonides Medical Center | |
| Brooklyn, New York, United States, 11219 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11042 | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| United States, North Dakota | |
| Dakota Cancer Institute at Innovis Health - Dakota Clinic | |
| Fargo, North Dakota, United States, 58103-4940 | |
| Meritcare Roger Maris Cancer Center | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Children's Medical Center - Dayton | |
| Dayton, Ohio, United States, 45404 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Columbus Children's Hospital | |
| Columbus, Ohio, United States, 43205-2696 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Forum Health-Tod Childrens Hospital | |
| Youngstown, Ohio, United States, 44501 | |
| Toledo Children's Hospital | |
| Toledo, Ohio, United States, 43601 | |
| United States, Oregon | |
| Doernbecher Children's Hospital at Oregon Health & Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213-2583 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-1320 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, South Carolina | |
| Palmetto Health South Carolina Cancer Center | |
| Columbia, South Carolina, United States, 29203 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105-1080 | |
| Sioux Valley Hospital at 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, 37901 | |
| Vanderbilt Children's Hospital | |
| Nashville, Tennessee, United States, 37232-6310 | |
| United States, Texas | |
| MBCCOP - South Texas Pediatrics | |
| San Antonio, Texas, United States, 78229-3900 | |
| Covenant Children's Hospital | |
| Lubbock, Texas, United States, 79410 | |
| Children's Hospital of Austin | |
| Austin, Texas, United States, 78701 | |
| Methodist Cancer Center at Methodist Specialty and Transplant Hospital | |
| San Antonio, Texas, United States, 78229-3902 | |
| Texas Tech University Health Sciences Center School of Medicine | |
| Amarillo, Texas, United States, 79106 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Utah | |
| Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84113 | |
| United States, Virginia | |
| Children's Hospital of the King's Daughters | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| Deaconess Medical Center | |
| Spokane, Washington, United States, 99210-0248 | |
| Group Health Eastside Hospital | |
| Redmond, Washington, United States, 98052 | |
| Mary Bridge Children's Hospital and Health Center | |
| Tacoma, Washington, United States, 98415-0299 | |
| United States, West Virginia | |
| Cabell Huntington Hospital | |
| Huntington, West Virginia, United States, 25701 | |
| United States, Wisconsin | |
| Bellin Memorial Hospital | |
| Green Bay, Wisconsin, United States, 54301 | |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | |
| La Crosse, Wisconsin, United States, 54601 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Australia, New South Wales | |
| Sydney Children's Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6006 | |
| Canada, British Columbia | |
| British Columbia Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| 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 Western Ontario | |
| London, Ontario, Canada, N6C 2V5 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre at Pasqua Hospital | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| New Zealand | |
| Starship Children's Health | |
| Auckland, New Zealand | |
| Study Chair: | Bruce H. Cohen, MD | The Cleveland Clinic |
More Information
| Study ID Numbers: | CDR0000065924, COG-99703, CCG-99703 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003141 History of Changes |
| Health Authority: | United States: Federal Government |
|
childhood infratentorial ependymoma childhood supratentorial ependymoma disseminated neuroblastoma stage 4S neuroblastoma embryonal childhood rhabdomyosarcoma childhood high-grade cerebral astrocytoma childhood choroid plexus tumor previously untreated childhood rhabdomyosarcoma untreated childhood brain stem glioma untreated childhood supratentorial primitive neuroectodermal tumor untreated childhood cerebellar astrocytoma untreated childhood medulloblastoma newly diagnosed childhood ependymoma |
localized resectable neuroblastoma localized unresectable neuroblastoma regional neuroblastoma childhood spinal cord neoplasm childhood atypical teratoid/rhabdoid tumor childhood low-grade cerebral astrocytoma childhood central nervous system choriocarcinoma childhood central nervous system embryonal tumor childhood central nervous system germinoma childhood central nervous system mixed germ cell tumor childhood central nervous system teratoma childhood central nervous system yolk sac tumor |
|
Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Central Nervous System Neoplasms Cyclophosphamide Neuroblastoma Neoplasms, Connective and Soft Tissue Neoplasms by Site Cisplatin Neoplasms, Germ Cell and Embryonal Therapeutic Uses Alkylating Agents |
Etoposide Nervous System Neoplasms Neoplasms by Histologic Type Mitosis Modulators Nervous System Diseases Vincristine Antimitotic Agents Carboplatin Immunosuppressive Agents Pharmacologic Actions Thiotepa Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Tubulin Modulators |
