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Clinical Trials (PDQ®)

Combination Chemotherapy With or Without Rituximab in Treating Younger Patients With Stage III-IV Non-Hodgkin Lymphoma or B-Cell Acute Leukemia

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase III, Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and underNCI, OtherANHL1131
NCI-2012-01963, CDR0000732604, U10CA098543, COG-ANHL1131, NCT01595048

Trial Description

Summary

This randomized phase II/III trial studies how well giving combination chemotherapy with or without rituximab works in treating younger patients with stage III or stage IV non-Hodgkin lymphoma or B-cell acute leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibody, such as rituximab, can block cancer cells growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving combination chemotherapy together with rituximab is more effective in treating patients with non-Hodgkin lymphoma or B-cell acute leukemia.

Further Study Information

PRIMARY OBJECTIVES:

I. For the patients with advanced stage B-cell non-Hodgkin lymphoma (NHL)/Burkitt leukemia (B-AL) (stage III and lactate dehydrogenase (LDH) > Nx2, any stage IV or B-AL), to test whether adding 6 injections of rituximab to standard LMB chemotherapy regimen, improves the event-free survival (EFS) compared with LMB chemotherapy alone. (Phase III) II. For patients with primary mediastinal large B-cell lymphoma (PMLBL), to evaluate the EFS following treatment with the regimen dose-adjusted (DA)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride (EPOCH), and rituximab. (Phase II)

SECONDARY OBJECTIVES:

I. To study the complete remission (CR) rate and the overall survival (OS). II. To evaluate safety on all study arms including toxic deaths, adverse events recorded using the National Cancer Institute (NCI)-Common Terminology Criteria (CTC) V4 (non-hematological toxicity grade 3, infections grade 3 to 5), cardiac toxicity (CTC grade 2-5 and evolution of left ventricular ejection fraction [LVEF] and left ventricular shortening fraction [LVSF]), number of days with platelets transfusion, intensive-care unit admission, number of days with red cells transfusion, and rituximab infusion reactions.

III. To study the rate of patients with immunoglobulin (Ig; G, A, and M) levels abnormally low and lymphocyte count abnormally low at 1 year and until 5-year follow-up, to study the need for Ig infusions, and levels of post (previous and re-) vaccination antibodies at 1 year.

IV. To study long-term (at least 5 years) risks of the use of rituximab plus chemotherapy compared with LMB chemotherapy alone in children with advanced stage B-NHL/B-AL (all events related [certain and probable] to therapy). (Phase III) V. To study the long-term risk of DA-EPOCH-R regimen, especially the cardiac risk related to doxorubicin given at higher dose than usual in children, but infused over 96 hours (i.e., evaluation of CTC grade 2-5 and evolution of LVEF and LVSF). (Phase II)

TERTIARY OBJECTIVES:

I. To obtain data on positron emission tomography (PET)-computed tomography (CT) scan in childhood pediatric B-cell NHL. (Exploratory) II. To evaluate the potential prognostic value of Minimal Disseminated Disease (MDD) and Minimal Residual disease (MRD) in correlation with outcome. (Exploratory - Phase III) III. To perform an economic study comparing the cost-effectiveness ratio between 2 therapeutic strategies: LMB chemotherapy with versus without rituximab. (Exploratory - Phase III) IV. To characterize the pharmacokinetics of rituximab in combination with LMB chemotherapy in a subset of patients. (Exploratory - Phase III)

OUTLINE: This is a multicenter study.

Phase II (patients with PMLBL): Patients receive rituximab IV on day 1; prednisone orally (PO) twice daily (BID) or IV on day on days 1-5; etoposide IV continuously on days 1-4; doxorubicin hydrochloride IV continuously on days 1-4; vincristine sulfate IV continuously on days 1-4; and cyclophosphamide IV on day 5. Patients also receive filgrastim subcutaneously (SC) once daily (QD) beginning on day 6 until blood count recovers. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Phase III: Patients are stratified according to National Group (COG vs SFCE vs UK NCRI CCL CSG vs AIEOP vs BSPHO vs DCOG vs SEHOP vs PPLLSG vs Hungarian Society of Pediatric Oncologist and Pediatric Hematologist), histology (large cell vs non large cell [Burkitt, atypical Burkitt, B-AL, or L3-AL]), and chemotherapy group (1 vs 2). Patients are assigned to 1 of 2 treatment groups.

Group 1 (pre-phase central nervous system [CNS]-negative, cerebral spinal fluid [CSF]-negative): Patients receive vincristine sulfate IV on day 1; cyclophosphamide IV over 15 minutes on day 1; prednisone PO BID or methylprednisolone IV on days 1-7; methotrexate intrathecally (IT) and hydrocortisone IT on day 1. Patients are randomized to 1 of 2 treatment arms.

Arm I (R-COPADM induction therapy): Beginning 8 days later, patients receive rituximab IV on day 1; vincristine sulfate IV on day 1; prednisone PO BID or methylprednisolone IV on days 1-5; methotrexate IV over 3 hours on day 1; leucovorin calcium PO every 6 hours on days 2-4; cyclophosphamide IV over 15 minutes on days 2-4; doxorubicin hydrochloride over 1 hour on day 2; and methotrexate IT and hydrocortisone IT on days 2 and 6. Treatment repeats every 18-21 days for 2 courses. Consolidation therapy (R-COPADM): Patients receive rituximab IV on day 1; methotrexate IV over 3 hours on day 1; leucovorin calcium PO every 6 hours on days 2-4; cytarabine IV continuously on days 2-6; methotrexate IT on day 2; hydrocortisone IT on days 2 and 7; and cytarabine IT on day 7. Treatment repeats every 21 days for 2 courses.

Arm II (COPADM induction therapy): Beginning 8 days later, patients receive vincristine sulfate, prednisone or methylprednisolone, methotrexate, leucovorin calcium, cyclophosphamide, doxorubicin, methotrexate IT, and hydrocortisone IT as in arm I. Treatment repeats every 18-21 days for 2 courses.

Consolidation therapy (COPADM): Patients receive methotrexate IV over 3 hours on day 1; leucovorin calcium PO every 6 hours on days 2-4; cytarabine IV over 12 hours on days 2-6; methotrexate IT on day 2; hydrocortisone IT on days 2 and 7; and cytarabine IT on day 7. Treatment repeats every 21 days for 2 courses.

Group 2 (pre-phase B-AL, CNS-negative OR CNS-positive, CSF-negative OR CSF-positive): Patients receive vincristine sulfate IV on day 1; cyclophosphamide IV over 15 minutes on day 1; prednisone PO BID or methylprednisolone IV on days 1-7; methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1, 3, and 5; and leucovorin calcium PO BID on days 2 and 4. Patients are randomized to 1 of 2 treatment arms.

Arm III (R-COPADM induction therapy): Patients receive rituximab IV on days -2 (course 1) and 1; vincristine sulfate IV on day 1; prednisone PO or methylprednisolone IV on days 1-5; high-dose methotrexate IV over 4 hours* on day 1; leucovorin calcium PO every 6 hours on days 2-4; cyclophosphamide IV over 15 minutes on days 2-4; doxorubicin hydrochloride IV on day 2; and methotrexate IT, hydrocortisone IT, and cytarabine IT on days 2, 4, and 6. Treatment repeats every 21 days for 2 courses.

NOTE: *During the second course, patients with CSF-positive disease receive high-dose methotrexate IV over 24 hours (instead of 4 hours).

Consolidation therapy (R-COPADM): Patients receive rituximab IV on day 1; hydrocortisone IT and methotrexate IT on day 1; cytarabine IV over 12 hours on days 1-5; high-dose cytarabine IV over 3 hours on day 2-5; and etoposide IV over 2 hours on days 2-5. If CSF-positive, patients receive high-dose methotrexate IV over 24 hours on day 18, methotrexate IT, hydrocortisone IT, and cytarabine IT on day 19, and leucovorin calcium PO every 6 hours on days 19-21. Treatment repeats every 21 days for 2 courses.

Maintenance therapy (R-COPADM): Patients receive vincristine sulfate IV on day 1; prednisone PO or methylprednisolone IV on days 1-5; high-dose methotrexate IV over 4 hours on day 1; leucovorin calcium PO every 6 hours on days 2-4; cyclophosphamide IV over 15 minutes on days 2-3; doxorubicin hydrochloride over 1 hour on day 2; and methotrexate IT, hydrocortisone IT, and cytarabine IT on day 2. Beginning 28 days later, patients receive cytarabine subcutaneously (SC) every 12 hours on days 1-5 and etoposide IV over 90 minutes on days 1-3.

Arm IV (COPADM induction therapy): Patients receive vincristine sulfate, prednisone or methylprednisolone, high-dose methotrexate*, leucovorin calcium, cyclophosphamide, doxorubicin hydrochloride, and methotrexate, hydrocortisone, and cytarabine IT as in arm III. NOTE: *Patients with CSF-positive disease receive high-dose methotrexate IV over 24 hours (instead of 4 hours).

Consolidation therapy (COPADM): Patients receive hydrocortisone and methotrexate IT, cytarabine, high-dose cytarabine, and etoposide as in arm III consolidation therapy.

Maintenance therapy (COPADM): Patients receive vincristine sulfate, prednisone or methylprednisolone, high-dose methotrexate*, leucovorin calcium, cyclophosphamide, doxorubicin hydrochloride, methotrexate IT, hydrocortisone IT, cytarabine IT, cytarabine SC, and etoposide as in arm III maintenance therapy.

NOTE: *Patients with CSF-positive disease receive high-dose methotrexate IV over 24 hours.

Blood and tumor tissue samples are collected at baseline, during, and at the completion of study therapy for correlative studies.

After completion of study treatment, patients are followed-up for 5 years.

Eligibility Criteria

Inclusion Criteria:

  • Histologically or cytologically proven B-cell malignancies; Burkitt leukemia or B-cell acute leukemia (B-AL) (Burkitt leukemia = L3-AL), or diffuse large B-cell non-Hodgkin lymphoma (NHL), or aggressive mature B-cell NHL not otherwise specified or specifiable (phase III)
  • Stage III with elevated LDH level (B-high) [LDH > twice the institutional upper limit of the adult normal values (> Nx2)], any stage IV, or B-AL (phase III)
  • Histologically or cytologically proven primary mediastinal large B-cell lymphoma (PMLBL) (phase II)
  • No central nervous system (CNS) involvement
  • No follicular lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, or nodular marginal zone lymphoma
  • Tumor cell negative for CD20 (absence of result due to technical problems in the presence of other characteristics suggestive of BL/DLBCL, including genetic and phenotypic features, is not an exclusion criteria)
  • Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: 12 months for women and 5 months for men
  • Able to comply with scheduled follow-up and with management of toxicity
  • Signed informed consent from patients and/or their parents or legal guardians
  • No patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive human immunodeficiency virus (HIV) serology
  • Not pregnant or nursing
  • No severe active viral infection, especially hepatitis B virus (HBV)
  • Severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of randomization
  • No HBV carrier status or positive serology; a patient is considered as HBV carrier or to have (had) HBV infection by any of the following criteria:
  • Unimmunized and hepatitis B surface antigen (HBsAg) and/or anti-HBs antibody and/or anti-hepatitis B core (HBc)-antibody positive
  • Immunized and HBsAg and/or anti-HBc antibody positive
  • For the Phase III trial, a patient without a known history of HBV could be randomized in the study if the serology results are not available at the time of the randomization; however, if the serology results are positive or not available at day 6 (the first day to receive rituximab, if so randomized), the patient must be withdrawn from the study whatever the allocated treatment arm; for the phase II trial, the hepatitis B serology results must be available before registration
  • No patients who, for any reason, are not able to comply with the national legislation
  • No past or current anti-cancer treatment except corticosteroids for less than one week
  • No participation in another investigational drug clinical trial
  • No prior exposure to rituximab

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

National Cancer Institute

Thomas GrossPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 Children's Hospital of Alabama at University of Alabama at Birmingham
 Alyssa T Reddy Ph: 205-934-0309
  Mobile
 University of South Alabama Mitchell Cancer Institute
 Felicia L Wilson Ph: 251-665-8000
Arizona
  Phoenix
 Phoenix Children's Hospital
 Jessica Boklan Ph: 602-546-0920
Arkansas
  Little Rock
 Arkansas Children's Hospital at the University of Arkansas for Medical Sciences
 David L Becton Ph: 501-364-7373
California
  Downey
 Southern California Permanente Medical Group
 Robert M Cooper Ph: 626-564-3455
  Loma Linda
 Loma Linda University Cancer Institute at Loma Linda University Medical Center
 Antranik A Bedros Ph: 909-558-3375
  Long Beach
 Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
 Theodore Zwerdling Ph: 562-933-5437
  Los Angeles
 Children's Hospital Los Angeles
 Leo Mascarenhas Ph: 323-361-4110
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Fataneh (Fae) Majlessipour Ph: 310-423-8965
  Oakland
 Children's Hospital and Research Center Oakland
 Carla B Golden Ph: 510-450-7600
 Kaiser Permanente-Oakland
 Steven K Bergstrom Ph: 626-564-3455
  Orange
 Children's Hospital of Orange County
 Violet Shen Ph: 714-997-3000
  Palo Alto
 Lucile Packard Children's Hospital at Stanford University Medical Center
 Neyssa M Marina Ph: 650-498-7061
  Email: clinicaltrials@med.stanford.edu
  Sacramento
 University of California Davis Cancer Center
 Jay Michael S Balagtas Ph: 916-734-3089
  San Diego
 Rady Children's Hospital - San Diego
 William D Roberts Ph: 858-966-5934
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Michelle L Hermiston Ph: 877-827-3222
Colorado
  Aurora
 Children's Hospital Colorado Center for Cancer and Blood Disorders
 Kelly W Maloney Ph: 720-777-6672
  Denver
 Presbyterian - St. Luke's Medical Center
 Jennifer J Clark Ph: 866-775-6246
Connecticut
  Hartford
 Connecticut Children's Medical Center
 Michael S Isakoff Ph: 860-545-9981
  New Haven
 Yale Cancer Center
 Nina S Kadan-Lottick Ph: 203-785-5702
Delaware
  Wilmington
 Alfred I. duPont Hospital for Children
 Christopher N Frantz Ph: 302-651-5755
District of Columbia
  Washington
 Children's National Medical Center
 Jeffrey S Dome Ph: 202-884-2549
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 Aziza T Shad Ph: 202-444-0381
Florida
  Fort Myers
 Children's Hospital of Southwest Florida
 Emad K Salman Ph: 239-343-5333
  Gainesville
 UF Health Cancer Center
 William B Slayton Ph: 352-273-8675
  Email: trials@cancer.ufl.edu
  Jacksonville
 Nemours Children's Clinic
 Eric S Sandler Ph: 904-697-3529
  Orlando
 Arnold Palmer Hospital for Children
 Vincent F Giusti Ph: 321-841-7246
  Email: CancerClinicalTrials@orlandohealth.com
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Fouad M Hajjar Ph: 407-303-5623
 Nemours Children's Hospital
 Ramamoorthy Nagasubramanian Ph: 407-650-7150
Georgia
  Atlanta
 AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
 Howard M Katzenstein Ph: 800-811-8480
  Augusta
 Medical College of Georgia Cancer Center
 Colleen H McDonough Ph: 706-721-1663
  Email: cancer@georgiahealth.edu
  Savannah
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 J. M Johnston Ph: 912-350-8568
Hawaii
  Honolulu
 Cancer Research Center of Hawaii
 Robert W Wilkinson Ph: 808-983-6090
Idaho
  Boise
 Mountain States Tumor Institute at St. Luke's Regional Medical Center
 Eugenia Chang Ph: 800-845-4624
Illinois
  Chicago
 Ann and Robert H. Lurie Children's Hospital of Chicago
 Joanna L Weinstein Ph: 773-880-4562
 University of Illinois Cancer Center
 Mary L Schmidt Ph: 312-355-3046
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Ricarchito B Manera Ph: 708-226-4357
  Peoria
 Saint Jude Midwest Affiliate
 Karen S Fernandez Ph: 309-655-3258
  Springfield
 Simmons Cooper Cancer Institute
 Gregory P Brandt Ph: 217-545-7929
Indiana
  Indianapolis
 Riley's Children Cancer Center at Riley Hospital for Children
 Robert J Fallon Ph: 317-274-2552
 St. Vincent Indianapolis Hospital
 Bassem I Razzouk Ph: 317-338-2194
Iowa
  Des Moines
 Blank Children's Hospital
 Wendy L Woods-Swafford Ph: 515-241-6729
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Ayman A El-Sheikh Ph: 800-237-1225
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 Lars M Wagner Ph: 859-257-3379
  Louisville
 Kosair Children's Hospital
 Kenneth G Lucas Ph: 866-530-5516
  Email: CTO@hmc.psu.edu
Louisiana
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Craig Lotterman Ph: 888-562-4763
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Joseph M Wiley Ph: 410-601-6266
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Ido Paz-Priel Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Carlos Rodriguez-Galindo Ph: 866-790-4500
 Floating Hospital for Children at Tufts - New England Medical Center
 Michael J Kelly Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
 Massachusetts General Hospital
 Howard J Weinstein Ph: 877-726-5130
Michigan
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Hadi Sawaf Ph: 313-343-3166
  East Lansing
 Breslin Cancer Center at Ingham Regional Medical Center
 Renuka Gera Ph: 517-975-9547
Minnesota
  Minneapolis
 Children's Hospitals and Clinics of Minnesota - Minneapolis
 Bruce C Bostrom Ph: 612-813-5193
  Rochester
 Mayo Clinic Cancer Center
 Paul J Galardy Ph: 507-538-7623
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Gail C Megason Ph: 601-815-6700
Missouri
  Columbia
 Columbia Regional Hospital
 Thomas W Loew Ph: 573-882-7440
  Kansas City
 Children's Mercy Hospital
 Maxine L Hetherington Ph: 816-234-3265
  Saint Louis
 David C. Pratt Cancer Center at St. John's Mercy
 Bethany G. Sleckman Ph: 913-948-5588
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Robert J Hayashi Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 Nik Farahana N Rashid Ph: 702-384-0013
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Sara Chaffee Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New Jersey
  Hackensack
 Hackensack University Medical Center Cancer Center
 Burton E Appel Ph: 201-996-2879
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Steven L Halpern Ph: 973-971-5900
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Richard A Drachtman Ph: 732-235-8675
  Newark
 Newark Beth Israel Medical Center
 Stacey Rifkin-Zenenberg Ph: 973-926-7230
  Paterson
 St. Joseph's Hospital and Medical Center
 Mary A Bonilla Ph: 973-754-2909
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Koh B Boayue Ph: 505-272-6972
 Thomas G Gross Ph: 614-722-3515
  Email: Thomas.Gross@nationwidechildrens.org
New York
  Albany
 Albany Medical Center Hospital
 Vikramjit S Kanwar Ph: 518-262-3368
  Bronx
 Montefiore Medical Center
 Peter D Cole Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  Buffalo
 Roswell Park Cancer Institute
 Martin L Brecher Ph: 877-275-7724
  Mineola
 Winthrop University Hospital
 Mark E Weinblatt Ph: 866-946-8476
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Alice Lee Ph: 212-305-8615
 Mount Sinai Medical Center
 Birte Wistinghausen Ph: 212-824-7320
  Email: jenny.figueroa@mssm.edu
  Syracuse
 SUNY Upstate Medical University Hospital
 Karol H Kerr Ph: 315-464-5476
North Carolina
  Asheville
 Mission Hospitals - Memorial Campus
 Douglas J Scothorn Ph: 828-213-4150
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Stuart H Gold Ph: 877-668-0683
  Email: cancerclinicaltrials@med.unc.edu
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Joel A Kaplan Ph: 704-355-2884
 Presbyterian Cancer Center at Presbyterian Hospital
 Paulette C Bryant Ph: 704-384-5369
  Durham
 Duke Cancer Institute
 Susan G Kreissman Ph: 888-275-3853
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Thomas W McLean Ph: 336-713-6771
Ohio
  Akron
 Akron Children's Hospital
 Steven J Kuerbitz Ph: 330-543-3193
  Cincinnati
 Cincinnati Children's Hospital Medical Center
 John P Perentesis Ph: 513-636-2799
  Cleveland
 Seidman Cancer Center at University Hospitals/Case Medical Center
 Yousif (Joe) H Matloub Ph: 216-844-5437
  Columbus
 Nationwide Children's Hospital
 Mark A Ranalli Ph: 614-722-2708
  Dayton
 Dayton Children's - Dayton
 Emmett H Broxson Ph: 800-228-4055
  Toledo
 Mercy Children's Hospital
 Rama Jasty Ph: 419-251-8210
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Rene Y McNall-Knapp Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Portland
 Knight Cancer Institute at Oregon Health and Science University
 Linda C. Stork Ph: 503-494-1080
  Email: trials@ohsu.edu
 Legacy Emanuel Children's Hospital
 Janice F Olson Ph: 503-413-2560
Pennsylvania
  Bethlehem
 Lehigh Valley Hospital - Muhlenberg
 Philip M Monteleone Ph: 484-884-2201
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Jeffrey S Taylor Ph: 570-271-5251
  Hershey
 Penn State Children's Hospital
 Lisa M McGregor Ph: 717-531-6012
  Philadelphia
 Children's Hospital of Philadelphia
 Frank M Balis Ph: 215-590-2810
 Children's Oncology Group
 Thomas G Gross Ph: 614-722-3515
  Email: Thomas.Gross@nationwidechildrens.org
 St. Christopher's Hospital for Children
 Gregory E Halligan Ph: 215-427-8991
  Pittsburgh
 Children's Hospital of Pittsburgh of UPMC
 Peter H Shaw Ph: 412-692-5573
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Jacqueline M Kraveka Ph: 843-792-9321
  Columbia
 Palmetto Health South Carolina Cancer Center
 Ronnie W. Neuberg Ph: 803-434-3680
  Greenville
 BI-LO Charities Children's Cancer Center
 Nichole L Bryant Ph: 864-241-6251
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Kayelyn J Wagner Ph: 605-328-1367
Tennessee
  Knoxville
 East Tennessee Children's Hospital
 Ray C Pais Ph: 865-541-8266
  Nashville
 Vanderbilt-Ingram Cancer Center
 Haydar A Frangoul Ph: 800-811-8480
Texas
  Austin
 Dell Children's Medical Center of Central Texas
 Sharon K Lockhart Ph: 512-324-8022
  Corpus Christi
 Driscoll Children's Hospital
 M. C Johnson Ph: 361-694-5311
  Dallas
 Medical City Dallas Hospital
 Carl Lenarsky Ph: 972-566-5588
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Martha M Stegner Ph: 214-648-7097
  Houston
 Dan L. Duncan Cancer Center at Baylor College of Medicine
 Timothy C Griffin Ph: 800-284-7370
  San Antonio
 Children's Hospital of San Antonio
 Timothy C Griffin Ph: 800-284-7370
 Methodist Children's Hospital of South Texas
 Jaime Estrada Ph: 210-575-7000
  Temple
 Scott and White Cancer Institute
 Guy H Grayson Ph: 254-724-5407
Utah
  Salt Lake City
 Primary Children's Medical Center
 Phillip E Barnette Ph: 801-585-5270
Virginia
  Norfolk
 Children's Hospital of The King's Daughters
 Eric J Lowe Ph: 757-668-7243
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Gita V Massey Ph: 804-628-1939
Washington
  Seattle
 Children's Hospital and Regional Medical Center - Seattle
 Douglas S Hawkins Ph: 866-987-2000
  Spokane
 Providence Cancer Center at Sacred Heart Medical Center
 Judy L Felgenhauer Ph: 800-228-6618
  Email: HopeBeginsHere@providence.org
  Tacoma
 Madigan Army Medical Center - Tacoma
 Melissa A Forouhar Ph: 253-968-0129
  Email: mamcdci@amedd.army.mil
 Mary Bridge Children's Hospital and Health Center - Tacoma
 Robert G Irwin Ph: 888-823-5923
  Email: ctsucontact@westat.com
Wisconsin
  Green Bay
 St. Vincent Hospital Regional Cancer Center
 John R Hill Ph: 920-433-8889
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Kenneth B DeSantes Ph: 608-262-5223
  Marshfield
 Marshfield Clinic - Marshfield Center
 Michael J McManus Ph: 715-389-4457
  Milwaukee
 Midwest Children's Cancer Center at Children's Hospital of Wisconsin
 Michael E Kelly Ph: 414-805-4380
Australia
New South Wales
  Randwick
 Sydney Children's Hospital
 Draga Barbaric Ph: (02) 9382-1721
  Westmead
 Children's Hospital at Westmead
 Geoffrey B McCowage Ph: 61-2-9845 1400
Queensland
  Herston
 Royal Children's Hospital
 Helen Irving Ph: 888-823-5923
  Email: ctsucontact@westat.com
Victoria
  Parkville
 Royal Children's Hospital
 Francoise M Mechinaud
  Email: crdo.info@mcri.edu.au
Western Australia
  Perth
 Princess Margaret Hospital for Children
 Catherine H Cole Ph: (08) 9340 8330
  Email: admin@childcancerresearch.com.au
Canada
Manitoba
  Winnipeg
 CancerCare Manitoba
 Rochelle A Yanofsky Ph: 866-561-1026
  Email: CIO_Web@cancercare.mb.ca
Newfoundland and Labrador
  Saint John's
 Janeway Children's Health and Rehabilitation Centre
 Lisa Anne B Goodyear Ph: 866-722-1126
Ontario
  Hamilton
 McMaster Children's Hospital at Hamilton Health Sciences
 Carol Portwine Ph: 905-521-2100ext74595
  Kingston
 Cancer Centre of Southeastern Ontario at Kingston General Hospital
 Mariana P Silva Ph: 613-544-2630
  Toronto
 Hospital for Sick Children
 Sarah W Alexander Ph: 416-813-7654ext2027
  Email: jason.mcguire@sickkids.ca
Quebec
  Montreal
 Hopital Sainte Justine
 Yvan Samson Ph: 514-345-4931
 Montreal Children's Hospital at McGill University Health Center
 Sharon B Abish Ph: 514-412-4445
  Email: info@thechildren.com
  Ste-Foy
 Centre de Recherche du Centre Hospitalier de l'Universite Laval
 Bruno Michon Ph: 418-525-4444
Saskatchewan
  Saskatoon
 Saskatoon Cancer Centre at the University of Saskatchewan
 Christopher Mpofu Ph: 306-655-2914

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01595048
ClinicalTrials.gov processed this data on August 07, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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