Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia - Full Text View

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075725

Purpose

RATIONALE: Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia.

Condition	Intervention	Phase
Leukemia	Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	High Risk B-Precursor Acute Lymphoblastic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Calcium Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Dexamethasone Cyclophosphamide 6-Mercaptopurine Prednisone Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Daunorubicin Doxorubicin Daunorubicin hydrochloride Doxorubicin hydrochloride Citrovorum factor Dexamethasone acetate Doxiproct plus Myocet Pegaspargase Cytarabine Thioguanine Leucovorin Calcium Dexamethasone Sodium Phosphate Vincristine sulfate Folinic acid calcium salt pentahydrate Mercaptopurine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Improvement of the treatment outcome [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relative safety and efficacy [ Designated as safety issue: Yes ]
Correlation of minimal residual disease (MRD) with event-free survival and overall survival at day 29 [ Designated as safety issue: No ]
Correlation of early marrow response status with MRD at day 29 [ Designated as safety issue: No ]
Identification of additional high-risk patients with MRD at day 29 [ Designated as safety issue: No ]

Estimated Enrollment:	2964
Study Start Date:	December 2003
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients in arm I receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.	Drug: cyclophosphamide Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously Radiation: radiation therapy Patients undergo radiation therapy periodically during study treatment
Arm II: Active Comparator Patients in arm II will receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.	Drug: cyclophosphamide Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously Radiation: radiation therapy Patients undergo radiation therapy periodically during study treatment
Arm III: Experimental Patients in arm III will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks.	Drug: cyclophosphamide Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: prednisone Given IV or orally Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously Radiation: radiation therapy Patients undergo radiation therapy periodically during study treatment
Arm IV: Experimental Patients in arm IV will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks.	Drug: cyclophosphamide Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: prednisone Given IV or orally Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously Radiation: radiation therapy Patients undergo radiation therapy periodically during study treatment

Show Detailed Description

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075725

Hide Study Locations

Locations

United States, Alabama
UAB Comprehensive Cancer Center	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309
University of South Alabama Mitchell Cancer Institute	Recruiting
Mobile, Alabama, United States, 36604
Contact: Felicia L. Wilson 251-405-5115
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center	Recruiting
Tucson, Arizona, United States, 85724-5024
Contact: Clinical Trials Office - Arizona Cancer Center at University o 520-626-9008
Banner Desert Medical Center	Recruiting
Mesa, Arizona, United States, 85202
Contact: Hardeo K. Panchoosingh 480-833-1123
Phoenix Children's Hospital	Recruiting
Phoenix, Arizona, United States, 85016-7710
Contact: Jessica L. Boklan 602-546-0920
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni 501-686-8274
United States, California
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital	Recruiting
Long Beach, California, United States, 90801
Contact: Jerry Z. Finklestein 562-492-1062
Children's Hospital Central California	Recruiting
Madera, California, United States, 93638-8762
Contact: Vonda L. Crouse 559-353-5480
Childrens Hospital Los Angeles	Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas 323-361-2529
Children's Hospital of Orange County	Recruiting
Orange, California, United States, 92868
Contact: Violet Shen 714-532-8636
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org
Children's Hospital and Research Center Oakland	Recruiting
Oakland, California, United States, 94609
Contact: Clinical Trial Office - Children's Hospital and Research Cente 510-450-7600
Jonsson Comprehensive Cancer Center at UCLA	Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719
Kaiser Permanente Medical Center - Oakland	Recruiting
Sacramento, California, United States, 95825
Contact: Vincent Kiley 916-474-2326
Loma Linda University Cancer Institute at Loma Linda University Medical Center	Recruiting
Loma Linda, California, United States, 92354
Contact: Clinical Trials Office - Loma Linda University Cancer Institut 909-558-3375
Rady Children's Hospital - San Diego	Recruiting
San Diego, California, United States, 92123-4282
Contact: Clinical Trials Office - Rady Children's Hospital - San Diego 858-966-5934
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048-1865
Contact: Carole H. Hurvitz 310-423-4423
Santa Barbara Cottage Children's Hospital	Recruiting
Santa Barbara, California, United States, 93105
Contact: Daniel Greenfield 805-569-8394
Southern California Permanente Medical Group	Recruiting
Downey, California, United States, 90027
Contact: Robert M. Cooper 323-783-5307
Sutter Cancer Center	Recruiting
Sacramento, California, United States, 95816
Contact: Clinical Trial Office - Sutter Cancer Center 916-454-6595
UCSF Helen Diller Family Comprehensive Cancer Center	Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222
University of California Davis Cancer Center	Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089
United States, Colorado
Children's Hospital Center for Cancer and Blood Disorders	Recruiting
Aurora, Colorado, United States, 80045
Contact: Kelly Maloney 720-777-6673
Presbyterian - St. Luke's Medical Center	Recruiting
Denver, Colorado, United States, 80218
Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen 303-839-6000
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center	Recruiting
Farmington, Connecticut, United States, 06360-2875
Contact: Clinical Trials Office - Carole and Ray Neag Comprehensive Can 800-579-7822
Yale Cancer Center	Recruiting
New Haven, Connecticut, United States, 06520-8028
Contact: Clinical Trials Office - Yale Cancer Center 203-785-5702
United States, Delaware
Alfred I. duPont Hospital for Children	Recruiting
Wilmington, Delaware, United States, 19803
Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre 302-651-5755
United States, District of Columbia
Children's National Medical Center	Recruiting
Washington, District of Columbia, United States, 20010-2970
Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381
Walter Reed Army Medical Center	Recruiting
Washington, District of Columbia, United States, 20307-5001
Contact: Clinical Trials Office - Walter Reed Army Medical Center 202-782-7840
United States, Florida
All Children's Hospital	Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Gregory Hale 727-767-4176
M.D. Anderson Cancer Center at Orlando	Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti 321-841-8588
Broward General Medical Center Cancer Center	Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Clinical Trials Office - Broward General Medical Center Cancer 954-355-5346
Florida Hospital Cancer Institute at Florida Hospital Orlando	Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623
Kaplan Cancer Center at St. Mary's Medical Center	Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda 561-844-6363
Lee Cancer Care of Lee Memorial Health System	Recruiting
Fort Myers, Florida, United States, 33901
Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt 877-680-0008
Baptist-South Miami Regional Cancer Program	Recruiting
Miami, Florida, United States, 33176
Contact: Doured Daghistani 305-274-1662
Memorial Cancer Institute at Memorial Regional Hospital	Recruiting
Hollywood, Florida, United States, 33021
Contact: Clinical Trials Office - Memorial Cancer Institute 954-985-3443
Miami Children's Hospital	Recruiting
Miami, Florida, United States, 33155
Contact: Enrique Escalon 305-662-8360x4960
Nemours Children's Clinic - Orlando	Recruiting
Orlando, Florida, United States, 32806
Contact: Paul R. Gordon 407-650-7330
Nemours Children's Clinic	Recruiting
Jacksonville, Florida, United States, 32207
Contact: Eric S. Sandler 904-697-3793
Sacred Heart Cancer Center at Sacred Heart Hospital	Recruiting
Pensacola, Florida, United States, 32504
Contact: Clinical Trials Office - Sacred Heart Cancer Center 850-416-4611
St. Joseph's Cancer Institute at St. Joseph's Hospital	Recruiting
Tampa, Florida, United States, 33607
Contact: Clinical Trials Office - St. Joseph's Cancer Institute 800-882-4123
University of Florida Shands Cancer Center	Recruiting
Gainesville, Florida, United States, 32610-0232
Contact: Clinical Trials Office - University of Florida Shands Cancer C 888-254-7581
University of Miami Sylvester Comprehensive Cancer Center - Miami	Recruiting
Miami, Florida, United States, 33136
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com
United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Recruiting
Savannah, Georgia, United States, 31403-3089
Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer 912-350-8568
MBCCOP - Medical College of Georgia Cancer Center	Recruiting
Augusta, Georgia, United States, 30912-3730
Contact: Colleen H. McDonough 706-721-3626
Winship Cancer Institute of Emory University	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Howard M. Katzenstein 404-785-0853
United States, Hawaii
Cancer Research Center of Hawaii	Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Clinical Trials Office - Cancer Research Center of Hawaii 808-586-2979
Tripler Army Medical Center	Recruiting
Tripler Amc, Hawaii, United States, 96859-5000
Contact: Melissa A. Forouhar 253-968-6144
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center	Recruiting
Boise, Idaho, United States, 83712-6297
Contact: Eugenia Chang 208-381-2731
United States, Illinois
Advocate Christ Medical Center	Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Sharad Salvi 708-684-4094
Advocate Lutheran General Cancer Care Center	Recruiting
Park Ridge, Illinois, United States, 60068-1174
Contact: Clinical Trials Office - Advocate Lutheran General Cancer Care 847-384-3621
Simmons Cooper Cancer Institute	Recruiting
Springfield, Illinois, United States, 62794-9677
Contact: Clinical Trials Office - Simmons Cooper Cancer Institute 217-545-7929
Children's Memorial Hospital - Chicago	Recruiting
Chicago, Illinois, United States, 60614
Contact: Stewart Goldman 773-880-3270
Cardinal Bernardin Cancer Center at Loyola University Medical Center	Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357
University of Chicago Cancer Research Center	Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424
University of Illinois Cancer Center	Recruiting
Chicago, Illinois, United States, 60612-7243
Contact: Clinical Trial Office - University of Illinois Cancer Center 312-355-3046
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center	Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552
St. Vincent Indianapolis Hospital	Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital 317-338-2194
United States, Iowa
Blank Children's Hospital	Recruiting
Des Moines, Iowa, United States, 50309
Contact: Clinical Trials Office - Blank Children's Hospital 515-241-6729
Holden Comprehensive Cancer Center at University of Iowa	Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service 800-237-1225
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160-7357
Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit 913-588-4709
United States, Kentucky
Kosair Children's Hospital	Recruiting
Louisville, Kentucky, United States, 40232
Contact: Clinical Trials Office - Kosair Children's Hospital 502-629-5500 CancerResource@nortonhealthcare.org
Lucille P. Markey Cancer Center at University of Kentucky	Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379
United States, Louisiana
Children's Hospital of New Orleans	Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Clinical Trials Office - Children's Hospital of New Orleans 504-894-5377
Tulane Cancer Center Office of Clinical Research	Recruiting
Alexandria, Louisiana, United States, 71315-3198
Contact: Clinical Trials Office - Tulane Cancer Center 504-988-6121
United States, Maine
CancerCare of Maine at Eastern Maine Medical Center	Recruiting
Bangor, Maine, United States, 04401
Contact: Clinical Trials Office - CancerCare of Maine 207-973-4274
Maine Children's Cancer Program at Barbara Bush Children's Hospital	Recruiting
Scarborough, Maine, United States, 04074-9308
Contact: Eric C. Larsen 207-885-7565
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital	Recruiting
Baltimore, Maryland, United States, 21215
Contact: Joseph M. Wiley 410-601-5864
Greenebaum Cancer Center at University of Maryland Medical Center	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu
United States, Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care	Recruiting
Springfield, Massachusetts, United States, 01199-0001
Contact: Satkiran S. Grewal 413-794-5316
Floating Hospital for Children at Tufts - New England Medical Center	Recruiting
Boston, Massachusetts, United States, 02111
Contact: Cynthia S. Kretschmar 617-636-5535
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130
UMASS Memorial Cancer Center - University Campus	Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Christopher P. Keuker 508-856-4225
United States, Michigan
Barbara Ann Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363
Breslin Cancer Center at Ingham Regional Medical Center	Recruiting
Lansing, Michigan, United States, 48910
Contact: Clinical Trials Office - Breslin Cancer Center at Ingham Regio 517-334-2765
Butterworth Hospital at Spectrum Health	Recruiting
Grand Rapids, Michigan, United States, 49503-2560
Contact: David S. Dickens 616-391-2086
C.S. Mott Children's Hospital at University of Michigan Medical Center	Recruiting
Ann Arbor, Michigan, United States, 48109-0286
Contact: Clinical Trials Office - C.S. Mott Children's Hospital 800-865-1125
CCOP - Kalamazoo	Recruiting
Kalamazoo, Michigan, United States, 49007-5381
Contact: Jeffrey S. Lobel 269-341-6350
Hurley Medical Center	Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center 810-762-8057
Van Elslander Cancer Center at St. John Hospital and Medical Center	Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo 313-343-3166
William Beaumont Hospital - Royal Oak Campus	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Clinical Trials Office - William Beaumont Hospital - Royal Oak 248-551-7695
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis	Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Clinical Trials Office - Children's Hospitals and Clinics of M 612-813-5193
Mayo Clinic Cancer Center	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
United States, Mississippi
University of Mississippi Cancer Clinic	Recruiting
Jackson, Mississippi, United States, 39216-4505
Contact: Gail C. Megason 601-984-5220
United States, Missouri
Cardinal Glennon Children's Hospital	Recruiting
St. Louis, Missouri, United States, 63104
Contact: William S. Ferguson 314-577-5638
Children's Mercy Hospital	Recruiting
Kansas City, Missouri, United States, 64108
Contact: Maxine Hetherington 816-234-3265
Ellis Fischel Cancer Center at University of Missouri - Columbia	Recruiting
Columbia, Missouri, United States, 65203
Contact: Clinical Trial Office - Ellis Fischel Cancer Center 573-882-7440
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Robert J. Hayashi 314-454-4118
United States, Nebraska
Children's Hospital	Recruiting
Omaha, Nebraska, United States, 68114-4113
Contact: Minnie Abromowitch 402-955-3950
UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465
United States, Nevada
CCOP - Nevada Cancer Research Foundation	Recruiting
Las Vegas, Nevada, United States, 89109-2306
Contact: Jonathan Bernstein 702-732-0971
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 cancerhelp@dartmouth.edu
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675
Hackensack University Medical Center Cancer Center	Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879
Newark Beth Israel Medical Center	Recruiting
Newark, New Jersey, United States, 07112
Contact: Clinical Trials Office - Newark Beth Israel Medical Center 973-926-3136
Overlook Hospital	Recruiting
Morristown, New Jersey, United States, 07962
Contact: Hazem Mahmoud 973-971-6720
Saint Peter's University Hospital	Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Douglas A. Cipkala 732-745-6674
St. Joseph's Hospital and Medical Center	Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary A. Bonilla 973-754-3349
United States, New Mexico
University of New Mexico Cancer Center	Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972
United States, New York
Albany Medical Center Hospital	Recruiting
Albany, New York, United States, 12208-3419
Contact: Vikramjit S. Kanwar 518-262-5513x25265
Albert Einstein Cancer Center at Albert Einstein College of Medicine	Recruiting
Bronx, New York, United States, 10461
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu
Mount Sinai Medical Center	Recruiting
New York, New York, United States, 10029
Contact: Birte Wistinghausen 212-241-7022
Stony Brook University Cancer Center	Recruiting
Stony Brook, New York, United States, 11794-9446
Contact: Clinical Trials Office - Stony Brook University Cancer Center 800-862-2215
New York Weill Cornell Cancer Center at Cornell University	Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848
NYU Cancer Institute at New York University Medical Center	Recruiting
New York, New York, United States, 10016
Contact: Elizabeth Raetz 212-263-8400
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724
Schneider Children's Hospital	Recruiting
New Hyde Park, New York, United States, 11040
Contact: Arlene S. Redner 718-470-3460
New York Medical College	Recruiting
Valhalla, New York, United States, 10595
Contact: Fevzi Ozkaynak 914-493-7997
SUNY Upstate Medical University Hospital	Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476
Winthrop University Hospital	Recruiting
Mineola, New York, United States, 11501
Contact: Contact Person 516-663-9500
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center	Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884
Duke Comprehensive Cancer Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853
Leo W. Jenkins Cancer Center at ECU Medical School	Recruiting
Greenville, North Carolina, United States, 27834
Contact: Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU M 252-744-2391
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432
Mission Hospitals - Memorial Campus	Recruiting
Asheville, North Carolina, United States, 28801
Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus 828-213-4150
Presbyterian Cancer Center at Presbyterian Hospital	Recruiting
Charlotte, North Carolina, United States, 28233-3549
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369
Wake Forest University Comprehensive Cancer Center	Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771
United States, North Dakota
CCOP - MeritCare Hospital	Recruiting
Fargo, North Dakota, United States, 58122
Contact: Nathan Kobrinsky 701-234-7544
United States, Ohio
Akron Children's Hospital	Recruiting
Akron, Ohio, United States, 44308-1062
Contact: Clinical Trials Office - Akron Children's Hospital 330-543-3193
Children's Medical Center - Dayton	Recruiting
Dayton, Ohio, United States, 45404-1815
Contact: Emmett Broxson 937-641-3111
Cincinnati Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-2799
Cleveland Clinic Taussig Cancer Center	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100
Medical University of Ohio Cancer Center	Recruiting
Toledo, Ohio, United States, 43614
Contact: Clinical Trials Office - Medical University of Ohio Cancer Cen 419-383-6583
Nationwide Children's Hospital	Recruiting
Columbus, Ohio, United States, 43205-2696
Contact: Amanda M. Termuhlen 614-722-3552
Rainbow Babies and Children's Hospital	Recruiting
Cleveland, Ohio, United States, 44106-5000
Contact: Yousif (Joe) H. Matloub 216-844-3345
Toledo Hospital	Recruiting
Toledo, Ohio, United States, 43606
Contact: Clinical Trials Office - Toledo Hospital 419-824-1842
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital	Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Gregory Kirkpatrick 918-502-6720
Oklahoma University Cancer Institute	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp 405-271-5311
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu
Legacy Emanuel Hospital and Health Center and Children's Hospital	Recruiting
Portland, Oregon, United States, 97227
Contact: Clinical Trials Office - Legacy Emanuel Hospital and Health Ce 503-413-8199
United States, Pennsylvania
Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104-9786
Contact: Richard Aplenc 267-426-7252
Children's Hospital of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Clinical Trials Office - Children's Hospital of Pittsburgh 412-692-5573
Geisinger Cancer Institute at Geisinger Health	Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute 570-271-5251
Lehigh Valley Hospital - Muhlenberg	Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Philip M. Monteleone 484-884-3333
Penn State Cancer Institute at Milton S. Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu
St. Christopher's Hospital for Children	Recruiting
Philadelphia, Pennsylvania, United States, 19134-1095
Contact: Clinical Trials Office - St. Christopher's Hospital for Childr 215-427-8991
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center	Recruiting
Providence, Rhode Island, United States, 02903
Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C 401-444-1488
United States, South Carolina
Greenville Hospital Cancer Center	Recruiting
Greenville, South Carolina, United States, 29605
Contact: Clinical Trials Office - Greenville Hospital Cancer Center 864-241-6251
Hollings Cancer Center at Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321
Palmetto Health South Carolina Cancer Center	Recruiting
Columbia, South Carolina, United States, 29203
Contact: Clinical Trials Office - Palmetto Health South Carolina Cancer 803-434-3680
United States, South Dakota
Sanford Cancer Center at Sanford USD Medical Center	Recruiting
Sioux Falls, South Dakota, United States, 57117-5039
Contact: Clinical Trials Office - Sanford Cancer Center 605-328-1367
United States, Tennessee
East Tennessee Children's Hospital	Recruiting
Knoxville, Tennessee, United States, 37901
Contact: Ray C. Pais 865-541-8266
T.C. Thompson Children's Hospital	Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Manoo G. Bhakta 423-778-7289
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480
United States, Texas
Baylor University Medical Center - Houston	Recruiting
Houston, Texas, United States, 77030-2399
Contact: Patrick A. Thompson 832-824-4029
CCOP - Scott and White Hospital	Recruiting
Temple, Texas, United States, 76508
Contact: Arlynn F. Mulne 254-724-2006
Cook Children's Medical Center - Fort Worth	Recruiting
Fort Worth, Texas, United States, 76104
Contact: Clinical Trials Office - Cook's Children's Medical Center 682-885-2103
Covenant Children's Hospital	Recruiting
Lubbock, Texas, United States, 79410
Contact: Latha Prasannan 806-725-4840
Medical City Dallas Hospital	Recruiting
Dallas, Texas, United States, 75230
Contact: Carl Lenarsky 972-566-6647x4439
M. D. Anderson Cancer Center at University of Texas	Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245
Dell Children's Medical Center of Central Texas	Recruiting
Austin, Texas, United States, 78723
Contact: Clinical Trials Office - Dell Children's Medical Center of Cen 512-324-8022
Methodist Children's Hospital of South Texas	Recruiting
San Antonio, Texas, United States, 78229-3993
Contact: Michael S. Grimley 210-575-7268
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097
Texas Tech University Health Sciences Center School of Medicine - Amarillo	Recruiting
Amarillo, Texas, United States, 79106
Contact: Curtis W. Turner 806-354-5434X264
University of Texas Health Science Center at San Antonio	Recruiting
San Antonio, Texas, United States, 78207
Contact: Paul Thomas 210-704-2187
United States, Utah
Primary Children's Medical Center	Recruiting
Salt Lake City, Utah, United States, 84113-1100
Contact: Phillip E. Barnette 801-662-4700
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus	Recruiting
Burlington, Vermont, United States, 05401
Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990
United States, Virginia
Carilion Medical Center for Children at Roanoke Community Hospital	Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mandy M. Atkinson 540-981-7376
Children's Hospital of The King's Daughters	Recruiting
Norfolk, Virginia, United States, 23507-1971
Contact: Eric J. Lowe 757-668-7243
Naval Medical Center - Portsmouth	Recruiting
Portsmouth, Virginia, United States, 23708-2197
Contact: Clinical Trials Office - Naval Medical Center - Portsmouth 757-953-5939
University of Virginia Cancer Center	Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kimberly P. Dunsmore 434-924-5105
Virginia Commonwealth University Massey Cancer Center	Recruiting
Richmond, Virginia, United States, 23298-0037
Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939
United States, Washington
Children's Hospital and Regional Medical Center - Seattle	Recruiting
Seattle, Washington, United States, 98105
Contact: Julie R. Park 206-987-2106
Madigan Army Medical Center - Tacoma	Recruiting
Tacoma, Washington, United States, 98431
Contact: Melissa A. Forouhar 253-968-6144
Mary Bridge Children's Hospital and Health Center - Tacoma	Recruiting
Tacoma, Washington, United States, 98405
Contact: Ronald Louie 253-403-3481
Providence Cancer Center at Sacred Heart Medical Center	Recruiting
Spokane, Washington, United States, 99220-2555
Contact: Judy L. Felgenhauer 509-474-2777
United States, West Virginia
Mary Babb Randolph Cancer Center at West Virginia University Hospitals	Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Contact Person 304-293-4500
West Virginia University Health Sciences Center - Charleston	Recruiting
Charleston, West Virginia, United States, 25302
Contact: Allen R. Chauvenet 304-388-1552
United States, Wisconsin
Marshfield Clinic - Marshfield Center	Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center 800-782-1581 ext. 94457
Midwest Children's Cancer Center at Children's Hospital of Wisconsin	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael E. Kelly 414-456-4170
St. Vincent Hospital Regional Cancer Center	Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer 920-433-8889
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223
Australia, Queensland
Royal Children's Hospital	Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Helen Irving 617-3636-8671
Australia, South Australia
Women's and Children's Hospital	Recruiting
North Adelaide, South Australia, Australia, 5006
Contact: Maria L. Kirby 61881617411
Australia, Victoria
Royal Children's Hospital	Recruiting
Parkville, Victoria, Australia, 3052
Contact: David Ashley 61393455652
Australia, Western Australia
Princess Margaret Hospital for Children	Recruiting
Perth, Western Australia, Australia, 6001
Contact: Catherine Cole 011-6189340-8238
Canada, Alberta
Alberta Children's Hospital	Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Douglas R. Strother 403-955-7272
University of Alberta Hospital	Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Sunil Jayantilal` S. Desai 780-407-8829
Canada, British Columbia
Children's & Women's Hospital of British Columbia	Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Mason C. Bond 604-875-2322
Canada, Manitoba
CancerCare Manitoba	Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Rochelle Yanofsky 204-787-4163
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre	Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: John (Jack) P. Hand 709-777-4799
Canada, Nova Scotia
IWK Health Centre	Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Margaret C. Yhap 902-470-8778
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital	Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Mariana P. Silva 613-5496666x3833
Children's Hospital of Eastern Ontario	Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Jacqueline Halton 613-737-7600x2370
Children's Hospital of Western Ontario	Recruiting
London, Ontario, Canada, N6A 5W9
Contact: A. E.L. Cairney 519-685-8494
Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sylvain Baruchel 416-813-7795
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital	Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Mansoor M. Haq 306-766-2498
Saskatoon Cancer Centre at the University of Saskatchewan	Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Kaiser Ali 306-655-2744
New Zealand
Christchurch Hospital	Recruiting
Christchurch, New Zealand, 8140
Contact: Robin P. Corbett 643364-0740
Starship Children's Health	Recruiting
Auckland, New Zealand, 1
Contact: Lochie Teague 64930749496368
Switzerland
Swiss Pediatric Oncology Group Bern	Recruiting
Bern, Switzerland, 3010
Contact: Roland A. Ammann 41316329372
Swiss Pediatric Oncology Group Geneva	Recruiting
Geneva, Switzerland, 1205
Contact: Hulya A. Ozsahin 0041223824712
Swiss Pediatric Oncology Group Lausanne	Recruiting
Lausanne, Switzerland, 1011
Contact: Maja Beck Popovic 41213141111x3567

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Eric C. Larsen, MD

Maine Children's Cancer Program at Barbara Bush Children's Hospital

Ages Eligible for Study:	1 Year to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Responsible Party:	Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers:	CDR0000349182, COG-AALL0232
Study First Received:	January 9, 2004
Last Updated:	November 20, 2009
ClinicalTrials.gov Identifier:	NCT00075725 History of Changes
Health Authority:	Unspecified