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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00057811 |
Purpose
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug with rituximab may kill more cancer cells. Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab and rasburicase with combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell leukemia or lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Leukemia Lymphoma |
Biological: filgrastim Biological: rituximab Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: methotrexate Drug: methylprednisolone Drug: prednisone Drug: rasburicase Drug: therapeutic hydrocortisone Drug: vincristine sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB Therapy |
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2004 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
FAB B: Experimental
Therapies given IV, IT, orally, or subcutaneously
|
Biological: filgrastim
Given subcutaneously
Biological: rituximab
Given IV
Drug: cyclophosphamide
Given IV, IT, or orally
Drug: cytarabine
Given IV, IT, or orally
Drug: doxorubicin hydrochloride
Given IV, IT, or orally
Drug: leucovorin calcium
Given IV, IT, or orally
Drug: methotrexate
Given IV, IT, or orally
Drug: methylprednisolone
Given IV, IT, or orally
Drug: prednisone
Given IV, IT, or orally
Drug: rasburicase
Given IV
Drug: therapeutic hydrocortisone
Given IT
Drug: vincristine sulfate
Given IV, IT, or orally
|
|
FAB C: Experimental
Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate)
|
Biological: filgrastim
Given subcutaneously
Biological: rituximab
Given IV
Drug: cyclophosphamide
Given IV, IT, or orally
Drug: cytarabine
Given IV, IT, or orally
Drug: doxorubicin hydrochloride
Given IV, IT, or orally
Drug: etoposide
Given IV
Drug: leucovorin calcium
Given IV, IT, or orally
Drug: methotrexate
Given IV, IT, or orally
Drug: methylprednisolone
Given IV, IT, or orally
Drug: prednisone
Given IV, IT, or orally
Drug: rasburicase
Given IV
Drug: therapeutic hydrocortisone
Given IT
Drug: vincristine sulfate
Given IV, IT, or orally
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed mature B-lineage (CD20-positive) leukemia or lymphoma by the REAL classification of 1 of the following subtypes:
One of the following FAB prognostic groups:
Group C (high risk)
Bone marrow involvement with at least 25% blasts and/or CNS involvement meeting 1 or more of the following criteria:
NOTE: *A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Lurleen Wallace Comprehensive Cancer at University of Alabama - 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 | |
| Kaiser Permanente Medical Center - Oakland | |
| Sacramento, California, United States, 95825 | |
| Childrens 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 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93638-8762 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90027 | |
| Stanford Cancer Center | |
| Stanford, California, United States, 94305-5824 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
| Children's Hospital Center for Cancer and Blood Disorders | |
| Aurora, Colorado, United States, 80045 | |
| 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, Delaware | |
| Alfred I. duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19803 | |
| 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 | |
| Baptist-South Miami Regional Cancer Program | |
| Miami, Florida, United States, 33176 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803-1273 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Lee Cancer Care of Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33901 | |
| 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 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | |
| Tampa, Florida, United States, 33607 | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Curtis and 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, 30912-3730 | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Idaho | |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | |
| Boise, Idaho, United States, 83712-6297 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| St. Vincent Indianapolis Hospital | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kansas | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Kentucky | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40232 | |
| Lucille P. Markey Cancer Center at University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0093 | |
| United States, Maine | |
| CancerCare of Maine at Eastern Maine Medical 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, Michigan | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Breslin Cancer Center at Ingham Regional Medical Center | |
| Lansing, Michigan, United States, 48910 | |
| Butterworth Hospital at Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503-2560 | |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | |
| Ann Arbor, Michigan, United States, 48109-0286 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-5381 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| Masonic Cancer Center at University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Nebraska | |
| Children's Hospital | |
| Omaha, Nebraska, United States, 68114-4113 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| 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 Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Hackensack University Medical Center Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| St. Joseph's Hospital and Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| United States, New Mexico | |
| University of New Mexico Cancer 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 | |
| Brooklyn Hospital Center | |
| Brooklyn, New York, United States, 11201-5493 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| 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 | |
| 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 | |
| Presbyterian Cancer Center at Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| United States, Ohio | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| Children's Medical Center - Dayton | |
| Dayton, Ohio, United States, 45404-1815 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205-2696 | |
| Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106-5000 | |
| Akron Children's Hospital | |
| Akron, Ohio, United States, 44308-1062 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | |
| Portland, Oregon, United States, 97227 | |
| Oregon Health and Science University Cancer Institute | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital - Muhlenberg | |
| Bethlehem, Pennsylvania, United States, 18017 | |
| St. Christopher's Hospital for Children | |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| United States, South Carolina | |
| Greenville Hospital Cancer Center | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Tennessee | |
| East Tennessee Children's Hospital | |
| Knoxville, Tennessee, United States, 37901 | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| T.C. Thompson Children's Hospital | |
| Chattanooga, Tennessee, United States, 37403 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Baylor University Medical Center - Houston | |
| Houston, Texas, United States, 77030-2399 | |
| Covenant Children's Hospital | |
| Lubbock, Texas, United States, 79410 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Driscoll Children's Hospital | |
| Corpus Christi, Texas, United States, 78411 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| 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 | |
| United States, Virginia | |
| Carilion Medical Center for Children at Roanoke Community Hospital | |
| Roanoke, Virginia, United States, 24014 | |
| Children's Hospital of The King's Daughters | |
| Norfolk, Virginia, United States, 23507-1971 | |
| Inova Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042-3300 | |
| Virginia Commonwealth University Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| United States, West Virginia | |
| West Virginia University Health Sciences Center - Charleston | |
| Charleston, West Virginia, United States, 25302 | |
| United States, Wisconsin | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Australia, New South Wales | |
| Westmead Institute for Cancer Research at Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Royal Children's Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| Women's and Children's Hospital | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6001 | |
| Canada | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec, Canada, G1V 4G2 | |
| Canada, Alberta | |
| University of Alberta Hospital | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| 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, Newfoundland and Labrador | |
| Janeway Children's Health and Rehabilitation Centre | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| IWK Health Centre | |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Canada, Ontario | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| McMaster Children's Hospital at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Montreal Children's Hospital at McGill University Health Center | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Puerto Rico | |
| San Jorge Children's Hospital | |
| Santurce, Puerto Rico, 00912 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | |
| Bern, Switzerland, 3010 | |
| Study Chair: | Mitchell S. Cairo, MD | Herbert Irving Comprehensive Cancer Center |
More Information
| Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
| Study ID Numbers: | CDR0000271941, COG-ANHL01P1 |
| Study First Received: | April 7, 2003 |
| Last Updated: | June 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00057811 History of Changes |
| Health Authority: | United States: Federal Government |
|
drug/agent toxicity by tissue/organ Burkitt lymphoma stage I childhood large cell lymphoma stage I childhood small noncleaved cell lymphoma stage II childhood large cell lymphoma stage II childhood small noncleaved cell lymphoma stage III childhood large cell lymphoma |
stage III childhood small noncleaved cell lymphoma stage IV childhood large cell lymphoma stage IV childhood small noncleaved cell lymphoma untreated childhood acute lymphoblastic leukemia childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma |
|
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Hydrocortisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Abortifacient Agents Methotrexate |
Dermatologic Agents Etoposide Nucleic Acid Synthesis Inhibitors Methylprednisolone Hemisuccinate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Neoplasms Hydrocortisone acetate Leukemia, B-Cell |
