|
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: | NCT00002756 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them as induction intensification may kill more cancer cells.
PURPOSE: This phase II trial is studying how well induction intensification works in treating infants with newly diagnosed acute lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: filgrastim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | INDUCTION INTENSIFICATION AND ALLOGENEIC BONE MARROW TRANSPLANT IN INFANT ALL: A PEDIATRIC ONCOLOGY GROUP PILOT STUDY Induction Intensification and Allogeneic Bone Marrow Transplant in Infant ALL: A Children's Oncology Group Pilot Study |
| Estimated Enrollment: | 104 |
| Study Start Date: | June 1996 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia
Previously untreated except for the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
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, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Children's Hospital and Health Center - San Diego | |
| San Diego, California, United States, 92123-4282 | |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | |
| Long Beach, California, United States, 90801 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93638-8762 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Children's Hospital and Research Center - Oakland | |
| Oakland, California, United States, 94609-1809 | |
| Kaiser Permanente Medical Center - Oakland | |
| Sacramento, California, United States, 95825 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Santa Barbara Cottage Children's Hospital | |
| Santa Barbara, California, United States, 93105 | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90242-2814 | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| Sutter Cancer Center | |
| Sacramento, California, United States, 95816 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Connecticut | |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06360-2875 | |
| Yale Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Florida | |
| Baptist-South Miami Regional Cancer Program | |
| Miami, Florida, United States, 33176 | |
| Broward General Medical Center Cancer Center | |
| Ft. Lauderdale, Florida, United States, 33316 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803-1273 | |
| Kaplan Cancer Center at St. Mary's Medical Center | |
| West Palm Beach, Florida, United States, 33407 | |
| Sacred Heart Cancer Center at Sacred Heart Hospital | |
| Pensacola, Florida, United States, 32504 | |
| Nemours Children's Clinic - Orlando | |
| Orlando, Florida, United States, 32806 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Lee Cancer Care of Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33901 | |
| 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, Georgia | |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |
| Savannah, Georgia, United States, 31403-3089 | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 95813 | |
| United States, Idaho | |
| St. Luke's Mountain States Tumor Institute - Boise | |
| Boise, Idaho, United States, 83712-6297 | |
| United States, Illinois | |
| Advocate Christ Medical Center | |
| Oak Lawn, Illinois, United States, 60453 | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068-1174 | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62794-9620 | |
| United States, Indiana | |
| 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, Kansas | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| 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, 40536-0293 | |
| United States, Louisiana | |
| Children's Hospital of New Orleans | |
| New Orleans, Louisiana, United States, 70118 | |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| 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 | |
| Floating Hospital for Children at Tufts - New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| 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 | |
| Breslin Cancer Center at Ingham Regional Medical Center | |
| Lansing, Michigan, United States, 48910 | |
| 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 Hospitals and Clinics of Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| University of Minnesota Medical Center - Fairview | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| Keesler Medical Center - Keesler Air Force Base | |
| 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 | |
| St. Louis, Missouri, United States, 63104 | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| St. Louis, Missouri, United States, 63110 | |
| 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 | |
| Hackensack University Medical Center Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| 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 | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| Maimonides Medical Center | |
| Brooklyn, New York, United States, 11219 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| 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 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11040 | |
| Stony Brook University Cancer Center | |
| Stony Brook, New York, United States, 11794-8174 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Mission Hospitals - Memorial Campus | |
| Asheville, North Carolina, United States, 28801 | |
| Presbyterian Cancer Center at Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, Ohio | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195-5217 | |
| Children's Hospital Medical Center of Akron | |
| Akron, Ohio, United States, 44308-1062 | |
| Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106-5000 | |
| Tod Children's Hospital - Forum Health | |
| Youngstown, Ohio, United States, 44501 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| United States, Oklahoma | |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | |
| Tulsa, Oklahoma, United States, 74136 | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Legacy Emanuel Hospital and Health Center & Children's Hospital | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, Rhode Island | |
| Rhode Island Hospital Comprehensive Cancer Center | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Greenville Hospital System Cancer Center | |
| Greenville, South Carolina, United States, 29605 | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| 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 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6310 | |
| United States, Texas | |
| Baylor University Medical Center - Houston | |
| Houston, Texas, United States, 77030-2399 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104-9958 | |
| Covenant Children's Hospital | |
| Lubbock, Texas, United States, 79410 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| Methodist Children's Hospital of South Texas | |
| San Antonio, Texas, United States, 78229-3993 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390 | |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | |
| Amarillo, Texas, United States, 79106 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78207 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0209 | |
| United States, Utah | |
| Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84113-1100 | |
| 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 | |
| Children's Hospital of the King's Daughters | |
| Norfolk, Virginia, United States, 23507-1971 | |
| INOVA Fairfax Hospital | |
| Fairfax, Virginia, United States, 22031 | |
| Massey Cancer Center at Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298-0037 | |
| Naval Medical Center - Portsmouth | |
| Portsmouth, Virginia, United States, 23708-2197 | |
| 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 | |
| West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | |
| Charleston, West Virginia, United States, 25302 | |
| 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 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6001 | |
| 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, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Nova Scotia | |
| IWK Health Centre | |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Canada, Ontario | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| Montreal Children's Hospital at McGill University Health Center | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre at Pasqua Hospital | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon Cancer Centre at the University of Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | |
| Bern, Switzerland, 3010 | |
| Swiss Pediatric Oncology Group Geneva | |
| Geneva, Switzerland, 1205 | |
| Swiss Pediatric Oncology Group Lausanne | |
| Lausanne, Switzerland, 1011 | |
| Study Chair: | Zoann E. Dreyer, MD | Texas Children's Cancer Center |
More Information
| Study ID Numbers: | CDR0000064693, COG-P9407, POG-9407 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002756 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated childhood acute lymphoblastic leukemia acute undifferentiated leukemia |
|
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Hydrocortisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists 6-Mercaptopurine Hormones Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents Etoposide |
Nucleic Acid Synthesis Inhibitors Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Neoplasms Hydrocortisone acetate Antineoplastic Agents, Phytogenic Antimetabolites Daunorubicin Leukemia, Lymphoid |