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

Basic Trial Information

Trial Description

Summary

Randomized phase III trial to compare the effectiveness of chemotherapy with or without monoclonal antibody, interleukin-2, and sargramostim following stem cell transplantation in treating patients who have neuroblastoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 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 monoclonal antibody therapy, interleukin-2, and sargramostim following stem cell transplantation in treating neuroblastoma

Further Study Information

PRIMARY OBJECTIVES:

I. Determine if monoclonal antibody Chl4.18 + 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-ASCT response of CR, VGPR, or PR.

SECONDARY OBJECTIVES:

I. Determine if monoclonal antibody Chl4.18 + 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 INSS Stage 4 neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR.

III. 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, RT-PCR for tyrosine hydroxylase, PGP 9.5, and MAGE-1 in blood and bone marrow.

IV. Determine if change from baseline of MRD as measured by above parameters is associated with event free and overall survival V. Determine whether tumor biology at diagnosis correlates with event-free and overall survival, for either of the randomized regimens.

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

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

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

IX. 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 CCG-3981.

X. 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.

XI. To further describe and refine the EFS and OS estimates and baseline characteristics for subjects receiving Chl4.18 + cytokines + RA, following cessation of the randomized portion of the study.

XII. To further describe the safety and toxicity of Chl4.18 + 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 IL-2); and c) number of toxic deaths.

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

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

XV. To determine if the genotype of FcR and Kir/Kir-Ligand correlate with EFS.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to pre-autologous stem cell transplantation (ASCT) response (complete vs very good partial vs partial), stem cells received (purged vs unpurged), and frontline chemotherapy (COG-A3973 vs POG 9341/9342 vs COG-ANGL02P1 vs other therapy). A further stratum consists of patients with biopsy-confirmed post-ASCT persistent disease who are also enrolled on COG-A3973 or COG-ANBL0532. These patients are not randomized but 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 oral isotretinoin twice daily 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.

ARM II: Beginning on day 56 post-ASCT, patients receive immunotherapy comprising sargramostim (GM-CSF) subcutaneously (SC) or IV over 2 hours on days 0-13 during courses 1, 3, and 5 and monoclonal antibody Ch14.18 IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive interleukin-2 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 oral isotretinoin as in arm I beginning on and day 11 of immunotherapy.

Patients are followed periodically for 10 years.

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of neuroblastoma

• Categorized as high risk at 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

• Meets all of the following criteria:

• Patients must have completed therapy including intensive induction followed by autologous stem cell transplantation (ASCT) and radiotherapy

• 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

• Completed frontline therapies, examples of such therapy includes:

• Following treatment per COG-A3973 protocol

• Following treatment per POG-9340-42

• Following treatment per CCG-3891

• Following treatment on NANT-2001-02

• Enrollment on or following treatment per COG-ANBL02P1 protocol

• Enrollment on or following treatment per ANBL07P1

• Tandem transplant patients are eligible

• Following enrollment and treatment on or per COG-ANBL0532

• Following treatment per POG-9640 protocol

• Following treatment per COG-ANBL00P1 protocol

• Following treatment per CHP 594 or DFCI 34-DAT

• Other frontline therapy with permission from study chairs

• Must meet the International Neuroblastoma Response Criteria (INRC)for CR, VGPR, or PR for primary site, soft tissue metastases, and bone metastases AND must also meet the protocol specified criteria for bone marrow response as follows:

• No more than 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

• 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

• Prior to enrollment on ANBL0032, a determination of mandatory disease staging must be performed (tumor imaging studies including CT or MRI, MIBG scan, bone marrow aspiration & biopsy); 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; these patients will be enrolled on Stratum 07

• Performance status - Lansky 50-100%

• Performance status - Karnofsky 50-100%

• Total absolute phagocyte count (neutrophils and monocytes) ≥ 1,000/mm^3

• Bilirubin ≤ 1.5 times normal

• SGPT ≤ 5 times normal

• Veno-occlusive disease (if present) stable or improving

• Creatinine adjusted according to age as follows:

• No greater than 0.4 mg/dL (≤ 5 months)

• No greater than 0.5 mg/dL (6 months - 11 months)

• No greater than 0.6 mg/dL (1 year- 23 months)

• No greater than 0.8 mg/dL (2 years- 5 years)

• No greater than 1.0 mg/dL (6 years- 9 years)

• No greater than 1.2 mg/dL (10 years- 12 years)

• No greater than 1.4 mg/dL (13 years and over [female])

• No greater than 1.5 mg/dL (13 years to 15 years [male])

• No greater than 1.7 mg/dL (16 years and over [male])

• Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

• Shortening fraction ≥ 30% 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

• FEV1 and FVC > 60% predicted by pulmonary function test; for children who are unable to do 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

• No evidence of dyspnea at rest, no exercise intolerance

• Not pregnant

• Fertile patients must use effective contraception

• Seizure disorder allowed if well-controlled and on anticonvulsants

• CNS toxicity < grade 2

• No concurrent pentoxifylline

• No more than 1 prior stem cell transplantation

• No other concurrent cytokines or growth factors (e.g., filgrastim [G-CSF] or interferon)

• No IV immunoglobulin G within 2 weeks before, during, and for 1 week after monoclonal antibody Ch14.18 (arm II patients)

• 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 PBSC infusion (day from 2nd stem cell infusion for tandem transplant); patients must be enrolled no later than Day 100 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

• All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated

• No prior anti-GD2 antibody therapy

• No more than 1 prior myeloablative consolidation regimen

• No concurrent myelosuppressive chemotherapy (arm II patients)

• No concurrent corticosteroids unless for life-threatening conditions (e.g., increased intracranial pressure from CNS tumors or life-threatening allergic reactions)

• No radiographic contrast materials during and for at least 1 week after interleukin- 2 (arm II)

• At least 7 days since prior radiotherapy

• No other concurrent anticancer therapy

• No concurrent immunosuppressive drugs (e.g., cyclosporine)

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Alice Yu

Principal Investigator

U.S.A.
Alabama
	Birmingham
	Children's Hospital of Alabama at University of Alabama at Birmingham
		Alyssa T Reddy	Ph: 205-934-0309
	UAB Comprehensive Cancer Center
		Alyssa T Reddy	Ph: 205-934-0309
Arizona
	Phoenix
	Phoenix Children's Hospital
		Jessica Boklan	Ph: 602-546-0920
	Tucson
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Brenda J Wittman	Ph: 520-626-9008
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		David L Becton	Ph: 501-364-7373
California
	Arcadia
	Children's Oncology Group
		Alice L. Yu	Ph: 858-246-0027
			Email: cancercto@ucsd.edu
	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
	Los Angeles
	Childrens 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
		Vincent A Kiley	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
		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
	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
Florida
	Fort Lauderdale
	Broward General Medical Center Cancer Center
		Hector M Rodriguez-Cortes	Ph: 954-355-5346
	Fort Myers
	Lee Cancer Care of Lee Memorial Health System
		Emad K Salman	Ph: 239-343-5333
	Gainesville
	University of Florida Shands Cancer Center
		William B Slayton	Ph: 352-273-8675
			Email: trials@cancer.ufl.edu
	Hollywood
	Joe DiMaggio Children's Hospital
		Iftikhar Hanif	Ph: 954-265-2234
	Jacksonville
	Nemours Children's Clinic
		Eric S Sandler	Ph: 904-697-3529
	Miami
	Baptist-South Miami Regional Cancer Program
		Doured Daghistani	Ph: 800-599-2456
			Email: cancerinfo@baptisthealth.net
	Miami Children's Hospital
		Enrique A Escalon	Ph: 305-662-8360
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clifford A Selsky	Ph: 407-303-5623
	M.D. Anderson Cancer Center at Orlando
		Vincent F Giusti	Ph: 321-841-7246
	Nemours Children's Clinic - Orlando
		Ramamoorthy Nagasubramanian	Ph: 407-650-7150
	Pensacola
	Nemours Children's Clinic - Pensacola
		Jeffrey H Schwartz	Ph: 904-697-3529
	Saint Petersburg
	All Children's Hospital
		Aleksandra Petrovic	Ph: 727-767-2423
			Email: HamblinF@allkids.org
Georgia
	Atlanta
	AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
		Howard M Katzenstein	Ph: 888-785-1112
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		J. Martin Johnston	Ph: 912-350-8568
Illinois
	Chicago
	Ann and Robert H. Lurie Children's Hospital of Chicago
		David O Walterhouse	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
		Sharad N Salvi	Ph: 847-723-7570
	Peoria
	Saint Jude Midwest Affiliate
		Pedro A De Alarcon	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: 888-823-5923
			Email: ctsucontact@westat.com
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Raymond Tannous	Ph: 800-237-1225
Kentucky
	Lexington
	University of Kentucky Chandler Medical Center
		Martha F Greenwood	Ph: 859-257-3379
	Louisville
	Kosair Children's Hospital
		Salvatore J Bertolone	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
	Greenebaum Cancer Center at University of Maryland Medical Center
		Teresa A York	Ph: 800-888-8823
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Allen R. Chen	Ph: 410-955-8804
			Email: jhcccro@jhmi.edu
	Bethesda
	National Naval Medical Center
		Anne B Warwick	Ph: 301-319-2100
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
		Alison M Friedmann	Ph: 877-726-5130
	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
	Wayne State University
		Zhihong J Wang	Ph: 313-576-9363
	Flint
	Hurley Medical Center
		Susumu Inoue	Ph: 888-606-6556
	Grand Rapids
	Helen DeVos Children's Hospital at Spectrum Health
		David S Dickens	Ph: 616-267-1925
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
	Rochester
	Mayo Clinic Cancer Center
		Carola A. S. Arndt	Ph: 507-538-7623
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Rathi V Iyer	Ph: 601-815-6700
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		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
	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
		David B Wilson	Ph: 800-600-3606
			Email: info@siteman.wustl.edu
Nebraska
	Omaha
	Children's Hospital
		Minnie Abromowitch	Ph: 402-955-3949
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		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
	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
	Saint Peter's University Hospital
		Stanley Calderwood	Ph: 732-745-8600ext6163
			Email: kcovert@saintpetersuh.com
	Newark
	Newark Beth Israel Medical Center
		Peri Kamalakar	Ph: 973-926-7230
	Summit
	Overlook Hospital
		Steven L Halpern	Ph: 973-971-5900
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Koh B Boayue	Ph: 505-272-6972
New York
	Albany
	Albany Medical Center Hospital
		Vikramjit S Kanwar	Ph: 518-262-3368
	Bronx
	Montefiore Medical Center
		Rosanna J Ricafort	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
	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
	Valhalla
	New York Medical College
		Mehmet F Ozkaynak	Ph: 914-594-3794
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Orren Beaty	Ph: 828-213-4150
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Stuart H Gold	Ph: 877-668-0683
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Joel A Kaplan	Ph: 704-355-2884
	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
North Dakota
	Fargo
	Roger Maris Cancer Center at MeritCare Hospital
		Nathan L Kobrinsky	Ph: 701-234-6161
Ohio
	Cincinnati
	Cincinnati Children's Hospital Medical Center
		John P Perentesis	Ph: 513-636-2799
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Tanya M Tekautz	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
		Laura T Martin	Ph: 614-722-2708
	Toledo
	Toledo Hospital
		Dagmar T Stein	Ph: 419-824-1842
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
		Susan J Lindemulder	Ph: 503-494-1080
			Email: trials@ohsu.edu
	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
	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
		John M Maris	Ph: 215-590-2810
	St. Christopher's Hospital for Children
		Gregory E Halligan	Ph: 215-427-8991
	Pittsburgh
	Children's Hospital of Pittsburgh of UPMC
		Arthur K Ritchey	Ph: 412-692-5573
Rhode Island
	Providence
	Rhode Island Hospital Comprehensive Cancer Center
		Cindy L Schwartz	Ph: 401-444-1488
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
	Knoxville
	East Tennessee Children's Hospital
		Ray C Pais	Ph: 865-541-8266
	Memphis
	St. Jude Children's Research Hospital
		Wayne L Furman	Ph: 901-595-4644
	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
		Naomi J Winick	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
		Lisa R Bomgaars	Ph: 713-798-1354
			Email: burton@bcm.edu
	San Antonio
	Methodist Children's Hospital of South Texas
		Jaime Estrada	Ph: 210-575-7000
	University of Texas Health Science Center at San Antonio
		Anne-Marie R Langevin	Ph: 210-567-0653
			Email: che@uthscsa.edu
Utah
	Salt Lake City
	Primary Children's Medical Center
		Phillip E Barnette	Ph: 801-585-5270
Vermont
	Burlington
	Vermont Cancer Center at University of Vermont
		Alan C Homans	Ph: 802-656-8990
Virginia
	Charlottesville
	University of Virginia Cancer Center
		Kimberly P Dunsmore	Ph: 434-243-6143
	Falls Church
	Inova Fairfax Hospital
		Marshall A Schorin	Ph: 703-208-6650
	Norfolk
	Children's Hospital of The King's Daughters
		Eric J Lowe	Ph: 757-668-7243
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Kamar Godder	Ph: 804-628-1939
	Roanoke
	Carilion Medical Center for Children at Roanoke Community Hospital
		Mandy M Atkinson	Ph: 540-981-7376
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
		Alice L. Yu	Ph: 858-822-5354
			Email: cancercto@ucsd.edu
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 De Santes	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
	Sydney
	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
	Royal 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
		Stacy L Miller	Ph: 888-823-5923
			Email: ctsucontact@westat.com
Western Australia
	Perth
	Princess Margaret Hospital for Children
		Catherine H Cole	Ph: (08) 9340 8330
			Email: admin@childcancerresearch.com.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
		John P Hand	Ph: 866-722-1126
Nova Scotia
	Halifax
	IWK Health Centre
		Margaret C Yhap	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
		Anne E Cairney	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
	Ste-Foy
	Centre de Recherche du Centre Hospitalier de l'Universite Laval
		Bruno Michon	Ph: 418-525-4444
New Zealand
	Christchurch
	Christchurch Hospital
		Michael J Sullivan	Ph:  03 364 0640
Auckland
	Grafton
	Starship Children's Health
		Mark A Winstanley	Ph:  0800 728 436

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00026312
Information obtained from ClinicalTrials.gov on February 06, 2013

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