Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive30 and under at diagnosisNCINCI-2009-01064
CDR0000069018, COG-ANBL0032, ANBL0032, U10CA180886, U10CA030969, U10CA098543, COG-P9842, NCT00026312

Trial Description

Summary

This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.

Further Study Information

PRIMARY OBJECTIVES:

I. Determine if monoclonal antibody Ch14.18 (dinutuximab) + cytokines + isotretinoin (13-cis-retinoic acid, or RA) improves event free survival after myeloablative therapy and stem cell rescue as compared to RA alone, in high risk neuroblastoma patients who have achieved a pre-autologous stem cell transplant (ASCT) response of complete response (CR), very good partial response (VGPR), or partial response (PR).

SECONDARY OBJECTIVES:

I. Determine if monoclonal antibody Ch14.18 + cytokines + isotretinoin (13-cis-retinoic acid, or RA) improves overall survival after myeloablative therapy and stem cell rescue as compared to RA alone, in high risk neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR.

II. Determine if immunotherapy + RA improves event free survival and overall survival as compared to RA alone, in the subgroup of high risk International Neuroblastoma Staging System (INSS) stage 4 neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR.

III. Determine the toxicities of the combination of monoclonal antibody Ch14.18 with cytokines.

IV. To compare the outcome data of the patients with persistent disease documented by biopsy (Stratum 07) to the historical data for the analogous patients from Children's Cancer Group (CCG)-3981.

V. To further describe and refine the event free survival (EFS) and overall survival (OS) estimates and baseline characteristics for subjects receiving Ch14.18 + cytokines + RA, following cessation of the randomized portion of the study.

VI. To further describe the safety and toxicity of Ch14.18 + cytokines + RA under the new administration guidelines implemented following cessation of the randomized portion of the study with focus on: a) number of courses delivered per subject; b) number of dose reductions or stoppage (ch14.18 and/or interleukin [IL]-2); and c) number of toxic deaths.

TERTIARY OBJECTIVES:

I. In the subgroup of neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR, determine if there is a difference between the two randomized regimens in reducing the minimal residual disease (MRD) burden as detected by the following parameters: meta-iodobenylguanidine (MIBG) scan, immunocytology (IC) of blood and bone marrow samples, reverse transcriptase-polymerase chain reaction (RT-PCR) for tyrosine hydroxylase, phosphoglycolate phosphatase (PGP) 9.5, and melanoma antigen family A, 1 (MAGE-1) in blood and bone marrow.

II. Determine if change from baseline of MRD is associated with event free and overall survival III. Determine whether tumor biology at diagnosis correlates with event-free and overall survival, for either of the randomized regimens.

IV. To explore the relationship between antibody-dependent cellular cytoxicity (ADCC) and EFS.

V. To determine a descriptive profile of human anti-chimeric antibody (HACA) during immunotherapy.

VI. To determine the variability of 13-cis-retinoic-acid pharmacokinetics and relationship to pharmacogenomic parameters and determine if these levels and/or genetic variations correlate with EFS or systemic toxicity.

VII. To determine the potential effect of ch14.18 on cardiac repolarization and to evaluate ch14.18 plasma levels.

VIII. To determine if the presence of naturally occurring anti-glycan antibodies correlates with allergic reactions and blood levels of ch14.18.

IX. To determine if the genotype of Fc receptor (FcR) and killer cell immunoglobulin-like receptor (Kir)/Kir-ligand correlate with EFS.

X. To determine if natural killer cell p30-related protein (NKp30) isoform expression and single nucleotide polymorphism (SNP), and circulating ligand B7-H6 are prognostic of EFS or OS.

OUTLINE: Patients stratified with biopsy-confirmed post-ASCT persistent disease who are also enrolled on Children's Oncology Group (COG)-A3973 or COG-ANBL0532 are assigned to treatment Arm II. Patients in the first set of strata are randomized to 1 of 2 treatment arms.

ARM I: Beginning on day 67 post-ASCT, patients receive isotretinoin orally (PO) twice daily (BID) for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients may cross over to Arm II provided they have not experienced disease progression and have not received any further anti-neuroblastoma therapy following completion of isotretinoin therapy. (closed to accrual as of 4/16/2009)

ARM II: Beginning on day 56 post-ASCT, patients receive immunotherapy comprising sargramostim (GM-CSF) subcutaneously (SC) or intravenously (IV) over 2 hours on days 0-13 during courses 1, 3, and 5 and dinutuximab IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive aldesleukin IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive isotretinoin as in Arm I beginning on day 11 of immunotherapy.

After completion of study treatment, patients are followed up periodically for 10 years.

Eligibility Criteria

Inclusion Criteria:

  • All patients must be diagnosed with neuroblastoma, and categorized as high risk at the time of diagnosis; exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma are also eligible
  • All patients must have completed therapy including intensive induction followed by ASCT and radiotherapy to be eligible for ANBL0032; radiotherapy may be waived for patients who either have small adrenal masses which are completely resected up front, or who never have an identifiable primary tumor; examples of such therapies include:
  • Following treatment per A3973 protocol
  • Following treatment per Pediatric Oncology Group (POG)-9341/9342 protocol
  • Following treatment per CCG3891
  • Following treatment on New Approaches to Neuroblastoma Therapy (NANT) 2001-02
  • Enrollment on or following treatment per ANBL02P1
  • Enrollment on or following treatment per ANBL07P1
  • Tandem transplant patients are eligible:
  • Following treatment on or per ANBL0532
  • Following treatment per POG 9640
  • Following treatment per COG ANBL00P1
  • Following treatment per CHP 594/Dana-Farber Cancer Institute (DFCI) 34-DAT
  • No more than 12 months from the date of starting the first induction chemotherapy after diagnosis to the date of ASCT except for the rare occasions as noted below; for tandem ASCT patients, this will be the date of the FIRST stem cell infusion; exception: for those who are initially diagnosed as non-high risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma, the 12 months restriction should start from the date of induction therapy for high risk neuroblastoma (not from the initial induction therapy for non-high risk disease), to the date of ASCT
  • At pre-ASCT evaluation patients must meet the International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases and bone metastases; patients who meet those criteria must also meet the protocol specified criteria for bone marrow response as outlined below:
  • =< 10% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy
  • Patient who have no tumor seen on the prior bone marrow, and then have =< 10% tumor on any of the bilateral marrow aspirate/biopsy specimens done at pre-ASCT and/or pre-enrollment evaluation will also be eligible (note that per INRC this would have been defined as "overall" response of progressive disease [PD])
  • Prior to enrollment on ANBL0032, a determination of mandatory disease staging must be performed (tumor imaging studies including computed tomography [CT] or magnetic resonance imaging [MRI], MIBG scan, and vanillylmandelic acid [VMA]/homovanillic acid [HVA]; bone marrow aspirates are required but biopsy may be omitted if negative prior to ASCT); this disease assessment is required for eligibility and should be done preferably within 2 weeks, but must be done within a maximum of 4 weeks before enrollment
  • For those with residual disease before radiotherapy, re-evaluation of irradiated residual tumors is preferably performed at the earliest 5 days after completing radiotherapy; patients with residual disease are eligible; biopsy is not required; patients who have biopsy proven residual disease after ASCT will be enrolled on Stratum 07
  • Patients must not have progressive disease at the time of study enrollment except for protocol specified bone marrow response and except for elevations of catecholamines as the only sign of disease in a patient who had normal catecholamines at pre-ASCT evaluation
  • Patients must be enrolled before treatment begins; the date protocol therapy is projected to start must be no later than ten (10) calendar days after the date of study enrollment; patients should be enrolled preferably between day 56 and day 85 after peripheral blood stem cell (PBSC) infusion (day from 2nd stem cell infusion for tandem transplant); patients must be enrolled no later than day 200 after PBSC infusion; enrollment must occur after completion of radiotherapy, and after completion of tumor assessment post-ASCT and radiotherapy; informed consent should be obtained within 3 weeks pre-ASCT up to the time of registration
  • Patients must not have received prior anti-disialoganglioside (GD2) antibody therapy
  • Patients must have a Lansky or Karnofsky performance scale score of >= 50% and patients must have a life expectancy of >= 2 months
  • Total absolute phagocyte count (APC = %neutrophils + %monocytes) X white blood cell (WBC) is at least 1000/uL
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
  • No greater than 0.4 mg/dL (1 month to < 6 months)
  • No greater than 0.5 mg/dL (6 months to < 1 year)
  • No greater than 0.6 mg/dL (1 to < 2 years)
  • No greater than 0.8 mg/dL (2 to < 6 years)
  • No greater than 1.0 mg/dL (6 to < 10 years)
  • No greater than 1.2 mg/dL (10 to < 13 years)
  • No greater than 1.4 mg/dL (>= 13 years [female])
  • No greater than 1.5 mg/dL (13 to < 16 years [male])
  • No greater than 1.7 mg/dL (>= 16 years [male])
  • Total bilirubin =< 1.5 x normal
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 x normal
  • Veno-occlusive disease, if present, should be stable or improving
  • Shortening fraction of >= 27% by echocardiogram, or if shortening fraction abnormal, ejection fraction of >= 55% by gated radionuclide study or echocardiogram; note: the echocardiogram or gated radionuclide study must be performed within 4 weeks prior to enrollment
  • Forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) > 60% predicted by pulmonary function test; for children who are unable to do pulmonary function tests (PFTs), no evidence of dyspnea at rest and no exercise intolerance should be documented; note: the pulmonary function test must be performed within 4 weeks prior to enrollment
  • Patients with seizure disorder may be enrolled if on anticonvulsants and well-controlled; central nervous system (CNS) toxicity < grade 2
  • Written informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from parent or legal guardian
  • Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method; female patients who are lactating must agree to stop breast-feeding

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

    Alice Yu, Principal 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

    Alaska
    Anchorage

    Providence Cancer Center

    Judy L Felgenhauer
    Ph: 800-228-6618
    Email: HopeBeginsHere@providence.org

    Arizona
    Tucson

    Arizona Cancer Center at University of Arizona Health Sciences Center

    Lisa M Kopp
    Ph: 520-626-9008

    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

    Duarte

    City of Hope Comprehensive Cancer Center

    Alice L. Yu
    Ph: 619-543-2438
    Email: aliceyu@ucsd.edu

    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: 562-933-5600

    Los Angeles

    Children's Hospital Los Angeles

    Leo Mascarenhas
    Ph: 323-361-4110

    Madera

    Children's Hospital Central California

    Vonda L Crouse
    Ph: 866-353-5437

    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

    Sutter Cancer Center

    Alice L. Yu
    Ph: 619-543-2438
    Email: aliceyu@ucsd.edu

    San Diego

    Rady Children's Hospital - San Diego

    William D Roberts
    Ph: 858-966-5934

    San Francisco

    UCSF Helen Diller Family Comprehensive Cancer Center

    Robert E Goldsby
    Ph: 877-827-3222

    Colorado
    Aurora

    Children's Hospital Colorado Center for Cancer and Blood Disorders

    Brian S Greffe
    Ph: 720-777-6672

    Connecticut
    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

    Alice L. Yu
    Ph: 619-543-2438
    Email: aliceyu@ucsd.edu

    Florida
    Fort Lauderdale

    Broward General Medical Center Cancer Center

    Hector M Rodriguez-Cortes
    Ph: 954-355-5346

    Fort Myers

    Children's Hospital of Southwest Florida

    Emad K Salman
    Ph: 239-343-5333

    Hollywood

    Joe DiMaggio Children's Hospital

    Iftikhar Hanif
    Ph: 954-265-2234

    Jacksonville

    Nemours Children's Clinic

    Scott M Bradfield
    Ph: 904-697-3529

    Miami

    Miami Children's Hospital

    Enrique A Escalon
    Ph: 305-662-8360

    University of Miami Sylvester Comprehensive Cancer Center - Miami

    Julio C Barredo
    Ph: 866-574-5124
    Email: Sylvester@emergingmed.com

    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

    Saint Petersburg

    All Children's Hospital

    Gregory A Hale
    Ph: 727-767-2423
    Email: HamblinF@allkids.org

    Tampa

    St. Joseph's Children's Hospital of Tampa

    Erin M Cockrell
    Ph: 800-882-4123

    West Palm Beach

    Kaplan Cancer Center at St. Mary's Medical Center

    Narayana Gowda
    Ph: 888-823-5923
    Email: ctsucontact@westat.com

    Georgia
    Atlanta

    AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

    Glen Lew
    Ph: 404-785-1112

    Savannah

    Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    J. M Johnston
    Ph: 912-350-8568

    Hawaii
    Honolulu

    Kapiolani Medical Center for Women and Children

    Robert W Wilkinson
    Ph: 808-983-6090

    Tripler Army Medical Center

    Jeremy V Edwards
    Ph: 808-433-6336

    Illinois
    Chicago

    Ann and Robert H. Lurie Children's Hospital of Chicago

    Yasmin C Gosiengfiao
    Ph: 773-880-4562

    University of Chicago Cancer Research Center

    Susan L Cohn
    Ph: 773-834-7424

    University of Illinois Cancer Center

    Mary L Schmidt
    Ph: 312-355-3046

    Oak Lawn

    Keyser Family Cancer Center at Advocate Hope Children's Hospital

    Rebecca E McFall
    Ph: 847-723-7570

    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
    Louisville

    Kosair Children's Hospital

    Kenneth G Lucas
    Ph: 866-530-5516

    Louisiana
    New Orleans

    Children's Hospital of New Orleans

    Lolie C Yu
    Ph: 504-894-5377

    Maine
    Scarborough

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

    Eric C Larsen
    Ph: 207-396-8090
    Email: wrighd@mmc.org

    Maryland
    Baltimore

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Allen R. Chen
    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

    Springfield

    Baystate Medical Center

    Joanna G Luty
    Ph: 413-794-3565
    Email: tamara.wrenn@baystatehealth.org

    Michigan
    Ann Arbor

    C.S. Mott Children's Hospital at University of Michigan Medical Center

    Rajen Mody
    Ph: 800-865-1125

    Detroit

    Van Elslander Cancer Center at St. John Hospital and Medical Center

    Hadi Sawaf
    Ph: 313-343-3166

    Wayne State University

    Zhihong J Wang
    Ph: 313-576-9363

    Grand Rapids

    Helen DeVos Children's Hospital at Spectrum Health

    David S Dickens
    Ph: 616-267-1925

    Kalamazoo

    Bronson Methodist Hospital

    Katharina E Elliott
    Ph: 800-227-2345

    Minnesota
    Minneapolis

    Children's Hospitals and Clinics of Minnesota - Minneapolis

    Bruce C Bostrom
    Ph: 612-813-5193

    Masonic Cancer Center at University of Minnesota

    Emily G Greengard
    Ph: 612-624-2620

    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

    Cardinal Glennon Children's Hospital

    William S Ferguson
    Ph: 314-268-4000

    Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    David B Wilson
    Ph: 800-600-3606
    Email: info@siteman.wustl.edu

    Nebraska
    Omaha

    Children's Hospital

    Minnie Abromowitch
    Ph: 402-955-3949

    Fred and Pamela Buffett Cancer Center

    Minnie Abromowitch
    Ph: 402-955-3949

    Nevada
    Las Vegas

    CCOP - Nevada Cancer Research Foundation

    Jonathan Bernstein
    Ph: 702-384-0013

    Children's Specialty Center of Nevada

    Jonathan Bernstein
    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

    New Brunswick

    Saint Peter's University Hospital

    Stanley Calderwood
    Ph: 732-745-8600ext6163
    Email: kcovert@saintpetersuh.com

    Summit

    Overlook Hospital

    Steven L Halpern
    Ph: 973-971-5900

    New Mexico
    Albuquerque

    University of New Mexico Cancer Center

    Alice L. Yu
    Ph: 619-543-2438
    Email: aliceyu@ucsd.edu

    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

    Meghan A Higman
    Ph: 877-275-7724

    Mineola

    Winthrop University Hospital

    Mark E Weinblatt
    Ph: 866-946-8476

    New Hyde Park

    Schneider Children's Hospital

    Jonathan D Fish
    Ph: 718-470-3470

    New York

    Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    Alice Lee
    Ph: 212-305-8615

    Rochester

    James P. Wilmot Cancer Center at University of Rochester Medical Center

    Jeffrey R Andolina
    Ph: 585-275-5830

    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

    North Dakota
    Fargo

    Roger Maris Cancer Center at MeritCare Hospital

    Samuel O Anim
    Ph: 701-234-6161

    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

    Cleveland Clinic Taussig Cancer Center

    Margaret C Thompson
    Ph: 866-223-8100

    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

    Toledo Hospital

    Jamie L Dargart
    Ph: 419-824-1842

    Oklahoma
    Oklahoma City

    Stephenson Cancer Center at the University of Oklahoma

    Rene Y McNall-Knapp
    Ph: 405-271-4272
    Email: julie-traylor@ouhsc.edu

    Oregon
    Portland

    Legacy Emanuel Children's Hospital

    Janice F Olson
    Ph: 503-413-2560

    Legacy Emanuel Hospital and Health Center and Children's Hospital

    Janice F Olson
    Ph: 503-413-2560

    Pennsylvania
    Danville

    Geisinger Cancer Institute at Geisinger Health

    Jagadeesh Ramdas
    Ph: 570-271-5251

    Hershey

    Penn State Children's Hospital

    Lisa M McGregor
    Ph: 717-531-6012

    Philadelphia

    Children's Hospital of Philadelphia

    John M Maris
    Ph: 215-590-2810

    Pittsburgh

    Children's Hospital of Pittsburgh of UPMC

    Jean M Tersak
    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

    Cancer Centers of the Carolinas - Faris Road

    Cary E Stroud
    Ph: 864-241-6251

    South Dakota
    Sioux Falls

    Sanford Cancer Center at Sanford USD Medical Center

    Kayelyn J Wagner
    Ph: 605-328-1367

    Tennessee
    Memphis

    St. Jude Children's Research Hospital

    Wayne L Furman
    Ph: 866-278-5833
    Email: info@stjude.org

    Nashville

    Vanderbilt-Ingram Cancer Center

    Howard M Katzenstein
    Ph: 800-811-8480

    Texas
    Austin

    Dell Children's Medical Center of Central Texas

    Sharon K Lockhart
    Ph: 512-324-8022

    Dallas

    Medical City Dallas Hospital

    Carl Lenarsky
    Ph: 972-566-5588

    Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Tanya C Watt
    Ph: 214-648-7097

    Fort Worth

    Cook Children's Medical Center - Fort Worth

    Mary Meaghan P Granger
    Ph: 682-885-2103

    Houston

    Dan L. Duncan Cancer Center at Baylor College of Medicine

    Karen R Rabin
    Ph: 713-798-1354
    Email: burton@bcm.edu

    San Antonio

    Methodist Children's Hospital of South Texas

    Jaime Estrada
    Ph: 210-575-7000

    Utah
    Salt Lake City

    Primary Children's Medical Center

    Phillip E Barnette
    Ph: 801-585-5270

    Vermont
    Burlington

    University of Vermont Cancer Center

    Alan C Homans
    Ph: 802-656-4101

    Virginia
    Charlottesville

    University of Virginia Cancer Center

    Kimberly P Dunsmore
    Ph: 434-243-6143

    Norfolk

    Children's Hospital of The King's Daughters

    Eric J Lowe
    Ph: 757-668-7243

    Portsmouth

    Naval Medical Center - Portsmouth

    Bethany M Mikles
    Ph: 757-953-5939

    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

    West Virginia
    Morgantown

    Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Alice L. Yu
    Ph: 619-543-2438
    Email: aliceyu@ucsd.edu

    Wisconsin
    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
    Hunter Regional Mail Centre

    John Hunter Hospital

    Geoffrey B McCowage
    Ph: 61-2-9845 1400

    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 Brisbane and Women's Hospital

    Helen Irving
    Ph: 888-823-5923
    Email: ctsucontact@westat.com

    South Brisbane

    Lady Cilento Children's Hospital

    Helen Irving
    Ph: 888-823-5923
    Email: ctsucontact@westat.com

    South Australia
    North Adelaide

    Women's and Children's Hospital

    Maria L Kirby
    Ph: (08) 8161 7327
    Email: cywhs.oncsec@health.sa.gov.au

    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 8222
    Email: catherine.cole@health.wa.gov.au

    Canada

    Alberta
    Calgary

    Alberta Children's Hospital

    Douglas R Strother
    Ph: 403-220-6898
    Email: research4kids@ucalgary.ca

    Edmonton

    University of Alberta Hospital

    Sunil Jayantilal S Desai
    Ph: 780-407-6615
    Email: val.taylor@albertahealthservices.ca

    British Columbia
    Vancouver

    Children's and Women's Hospital of British Columbia

    Caron Strahlendorf
    Ph: 604-875-2345ext6477

    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

    Nova Scotia
    Halifax

    IWK Health Centre

    Conrad V Fernandez
    Ph: 902-470-8394

    Ontario
    Hamilton

    McMaster Children's Hospital at Hamilton Health Sciences

    Carol Portwine
    Ph: 905-521-2100ext74595

    Carol Portwine
    Ph: 905-521-2100ext74595

    London

    Children's Hospital of Western Ontario

    Shayna M Zelcer
    Ph: 519-685-8306

    Ottawa

    Children's Hospital of Eastern Ontario

    Jacqueline M Halton
    Ph: 613-738-3931

    Toronto

    Hospital for Sick Children

    Meredith S Irwin
    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

    Quebec

    Centre de Recherche du Centre Hospitalier de l'Universite Laval

    Bruno Michon
    Ph: 418-525-4444

    New Zealand

    Christchurch

    Christchurch Hospital

    Mark A Winstanley
    Ph: 0800 728 436

    Auckland
    Grafton

    Starship Children's Health

    Mark A Winstanley
    Ph: 0800 728 436

    See All Trial Sites

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00026312
    ClinicalTrials.gov processed this data on May 18, 2015

    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.