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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00058461 |
Purpose
RATIONALE: Chemotherapy drugs, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining ifosfamide, carboplatin, and etoposide with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well rituximab together with ifosfamide, carboplatin, and etoposide works in treating young patients with recurrent or refractory non-Hodgkin's lymphoma or acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: filgrastim Biological: rituximab Drug: carboplatin Drug: cytarabine Drug: etoposide Drug: ifosfamide Drug: methotrexate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of Rituximab And ICE Chemotherapy In Children With Recurrent/Refractory B-Cell (CD20+) Non-Hodgkin Lymphoma And B-Cell Acute Lymphoblastic Leukemia |
| Study Start Date: | November 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified by disease (B-cell large cell lymphoma or atypical precursor B-cell lmphoblastic lymphoma vs small non-cleaved cell lymphoma or B-cell acute lymphoblastic leukemia).
Patients receive ifosfamide IV over 2 hours and etoposide IV over 1 hour on days 3-5, rituximab IV on days 1 and 3, and carboplatin IV over 1 hour on day 3. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover.
Patients also receive intrathecal (IT) chemotherapy comprising methotrexate and cytarabine. Patients with B-cell large cell lymphoma and negative CSF cytology receive IT chemotherapy on day 3 of the first course only. Patients with small non-cleaved cell lymphoma or B-cell acute lymphoblastic leukemia and negative CSF cytology receive IT chemotherapy on day 3. All patients with positive CSF cytology receive IT chemotherapy on days 3, 10, and 17 of the first and second courses. Treatment repeats every 23 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 42-82 patients (21-41 per disease stratum) will be accrued for this study within 2-4 years.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed B-cell non-Hodgkin's lymphoma OR acute lymphoblastic leukemia
The following histologies are generally CD20+ and are eligible:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
No chronic renal insufficiency
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Prior stem cell transplantation allowed provided the following criteria are met:
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 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Kaiser Permanente Medical Center - Oakland | |
| Sacramento, California, United States, 95825 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93638-8762 | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90242-2814 | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| 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, 19899 | |
| 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 | |
| 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 | |
| Lee Cancer Care of Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33901 | |
| Miami Children's Hospital | |
| Miami, Florida, United States, 33155 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| 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 Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610-0232 | |
| University of Miami Sylvester Comprehensive Cancer Center | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| MBCCOP-Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912-3730 | |
| 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 | |
| Saint Jude Midwest Affiliate | |
| Peoria, Illinois, United States, 61637 | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62794-9620 | |
| 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 | |
| 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 | |
| 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 | |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| Tulane Cancer Center | |
| Alexandria, Louisiana, United States, 71315-3198 | |
| United States, Maine | |
| CancerCare of Maine at Eastern Maine Medial Center | |
| Bangor, Maine, United States, 04401 | |
| Maine Children's Cancer Program | |
| Scarborough, Maine, United States, 04074-9308 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| 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 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| 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 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| 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, Nevada | |
| Sunrise Hospital and Medical Center | |
| Las Vegas, Nevada, United States, 89109-2306 | |
| 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 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| St. Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| 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 | |
| Brooklyn Hospital Center | |
| Brooklyn, New York, United States, 11201-5493 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| 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 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11040 | |
| 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 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Presbyterian Cancer Center at Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| United States, Ohio | |
| Children's Hospital Medical Center of Akron | |
| Akron, Ohio, United States, 44308-1062 | |
| 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 | |
| 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 | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Institute of Oncology at Vilnius University | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-9786 | |
| 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 | |
| Comprehensive Cancer Center at Rhode Island Hospital | |
| 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 | |
| East Tennessee State University Cancer Center at Johnson City Medical Center | |
| Johnson City, Tennessee, United States, 37604 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6310 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Children's Hospital of Austin | |
| Austin, Texas, United States, 78701 | |
| Methodist Children's Hospital of South Texas | |
| San Antonio, Texas, United States, 78229-3993 | |
| Covenant Children's Hospital | |
| Lubbock, Texas, United States, 79410 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104-9958 | |
| 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, Texas, United States, 79106 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229-3900 | |
| United States, Utah | |
| Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84113-1100 | |
| United States, Virginia | |
| Massey Cancer Center at Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298-0037 | |
| Children's Hospital of the King's Daughters | |
| Norfolk, Virginia, United States, 23507-1971 | |
| INOVA Fairfax Hospital | |
| Fairfax, Virginia, United States, 22031 | |
| Carilion Cancer Center of Western Virginia | |
| Roanoke, Virginia, United States, 24029 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| Madigan Army Medical Center - Tacoma | |
| Tacoma, Washington, United States, 98431 | |
| United States, West Virginia | |
| 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, New South Wales | |
| Prince of Wales Private Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| Australia, Queensland | |
| Royal Children's Hospital | |
| Herston, 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, Alberta | |
| Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T2T 5C7 | |
| 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, Nova Scotia | |
| IWK Health Centre | |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Canada, Ontario | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 3N6 | |
| 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 | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| 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 | |
| Study Chair: | Timothy C. Griffin, MD | Cook Children's Medical Center - Fort Worth |
More Information
| Study ID Numbers: | CDR0000298751, COG-ANHL0121 |
| Study First Received: | April 7, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00058461 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood acute lymphoblastic leukemia recurrent childhood large cell lymphoma B-cell childhood acute lymphoblastic leukemia childhood diffuse large cell lymphoma recurrent childhood small noncleaved cell lymphoma |
childhood immunoblastic large cell lymphoma L3 childhood acute lymphoblastic leukemia recurrent childhood lymphoblastic lymphoma Burkitt lymphoma |
|
Antimetabolites Anti-Infective Agents Leukemia, Lymphoid Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Tumor Virus Infections Reproductive Control Agents Neoplasms, Experimental Lymphoma, B-Cell Leukemia Therapeutic Uses Abortifacient Agents |
Methotrexate Epstein-Barr Virus Infections Dermatologic Agents Alkylating Agents Lymphoma Etoposide Nucleic Acid Synthesis Inhibitors Cytarabine Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Rituximab Enzyme Inhibitors Carboplatin |