Isotretinoin with or without Dinutuximab, Aldesleukin, and Sargramostim following Stem Cell Transplant in Treating Patients with Neuroblastoma

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, Treatment30 and under at diagnosisANBL0032
NCI-2009-01064, CDR0000069018, COG-ANBL0032, 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 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

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

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

Patients must not have received prior anti-disialoganglioside (GD2) antibody therapy

Veno-occlusive disease, if present, should be stable or improving

Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 x normal

Total bilirubin =< 1.5 x normal

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

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])

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

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

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])

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

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

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 / Collaborators

National Cancer Institute

  • National Cancer Institute
Alice Lin-Tsing Yu, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

Children's Hospital of Alabama

Alyssa Terry Reddy
Ph: 205-934-0309

Alyssa Terry Reddy
Principal Investigator

Alaska
Anchorage

Providence Alaska Medical Center

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

Judy L. Felgenhauer
Principal Investigator

Arizona
Tucson

The University of Arizona Medical Center-University Campus

Lisa M. Kopp
Ph: 520-626-9008

Lisa M. Kopp
Principal Investigator

Arkansas
Little Rock

Arkansas Children's Hospital

David L. Becton
Ph: 501-364-7373

David L. Becton
Principal Investigator

California
Downey

Southern California Permanente Medical Group

Robert Michael Cooper
Ph: 626-564-3455

Robert Michael Cooper
Principal Investigator

Duarte

City of Hope Comprehensive Cancer Center

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

Alice Lin-Tsing Yu
Principal Investigator

Loma Linda

Loma Linda University Medical Center

Albert Kheradpour
Ph: 909-558-3375

Albert Kheradpour
Principal Investigator

Long Beach

Miller Children's and Women's Hospital Long Beach

Theodore Zwerdling
Ph: 562-933-5600

Theodore Zwerdling
Principal Investigator

Los Angeles

Children's Hospital Los Angeles

Leo Mascarenhas
Ph: 323-361-4110

Leo Mascarenhas
Principal Investigator

Madera

Children's Hospital Central California

Vonda Lee Crouse
Ph: 866-353-5437

Vonda Lee Crouse
Principal Investigator

Oakland

Children's Hospital and Research Center at Oakland

Carla Barbara Golden
Ph: 510-450-7600

Carla Barbara Golden
Principal Investigator

Kaiser Permanente-Oakland

Steven K. Bergstrom
Ph: 626-564-3455

Steven K. Bergstrom
Principal Investigator

Orange

Childrens Hospital of Orange County

Violet Shen
Ph: 714-997-3000

Violet Shen
Principal Investigator

Palo Alto

Lucile Packard Children's Hospital Stanford University

Neyssa Maria Marina
Ph: 650-498-7061
Email: clinicaltrials@med.stanford.edu

Neyssa Maria Marina
Principal Investigator

Sacramento

Sutter General Hospital

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

Alice Lin-Tsing Yu
Principal Investigator

University of California Davis Comprehensive Cancer Center

Jay Michael S. Balagtas
Ph: 916-734-3089

Jay Michael S. Balagtas
Principal Investigator

San Diego

Rady Children's Hospital - San Diego

William D. Roberts
Ph: 858-966-5934

William D. Roberts
Principal Investigator

San Francisco

UCSF Medical Center-Mission Bay

Robert Edward Goldsby
Ph: 877-827-3222

Robert Edward Goldsby
Principal Investigator

Colorado
Aurora

Children's Hospital Colorado

Brian Scott Greffe
Ph: 720-777-6672

Brian Scott Greffe
Principal Investigator

Connecticut
Hartford

Connecticut Children's Medical Center

Michael Scott Isakoff
Ph: 860-545-9981

Michael Scott Isakoff
Principal Investigator

New Haven

Yale University

Nina Singh Kadan-Lottick
Ph: 203-785-5702

Nina Singh Kadan-Lottick
Principal Investigator

Delaware
Wilmington

Alfred I duPont Hospital for Children

Christopher N. Frantz
Ph: 302-651-5755

Christopher N. Frantz
Principal Investigator

District of Columbia
Washington

Children's National Medical Center

Jeffrey Stuart Dome
Ph: 202-884-2549

Jeffrey Stuart Dome
Principal Investigator

MedStar Georgetown University Hospital

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

Alice Lin-Tsing Yu
Principal Investigator

Florida
Fort Lauderdale

Broward Health Medical Center

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

Hector M. Rodriguez-Cortes
Principal Investigator

Fort Myers

Golisano Children's Hospital of Southwest Florida

Emad K. Salman
Ph: 239-343-5333

Emad K. Salman
Principal Investigator

Hollywood

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Iftikhar Hanif
Ph: 954-265-2234

Iftikhar Hanif
Principal Investigator

Jacksonville

Nemours Children's Clinic-Jacksonville

Scott M. Bradfield
Ph: 904-697-3529

Scott M. Bradfield
Principal Investigator

Miami

Miami Children's Hospital

Enrique Alberto Escalon
Ph: 305-662-8360

Enrique Alberto Escalon
Principal Investigator

University of Miami Miller School of Medicine-Sylvester Cancer Center

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

Julio Cesar Barredo
Principal Investigator

Orlando

Arnold Palmer Hospital for Children

Vincent Ferdinando Giusti
Ph: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com

Vincent Ferdinando Giusti
Principal Investigator

Florida Hospital Orlando

Fouad M. Hajjar
Ph: 407-303-5623

Fouad M. Hajjar
Principal Investigator

Saint Petersburg

All Children's Hospital

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

Gregory Alan Hale
Principal Investigator

Tampa

Saint Joseph's Hospital/Children's Hospital-Tampa

Erin Marie Cockrell
Ph: 800-882-4123

Erin Marie Cockrell
Principal Investigator

West Palm Beach

Saint Mary's Hospital

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

Narayana Gowda
Principal Investigator

Georgia
Atlanta

Children's Healthcare of Atlanta - Egleston

Glen Lew
Ph: 404-785-1112

Glen Lew
Principal Investigator

Savannah

Memorial University Medical Center

J. Martin Johnston
Ph: 912-350-8568

J. Martin Johnston
Principal Investigator

Hawaii
Honolulu

Kapiolani Medical Center for Women and Children

Robert W. Wilkinson
Ph: 808-983-6090

Robert W. Wilkinson
Principal Investigator

Tripler Army Medical Center

Jeremy Vaughan Edwards
Ph: 808-433-6336

Jeremy Vaughan Edwards
Principal Investigator

Illinois
Chicago

Lurie Children's Hospital-Chicago

Yasmin Castellanes Gosiengfiao
Ph: 773-880-4562

Yasmin Castellanes Gosiengfiao
Principal Investigator

University of Chicago Comprehensive Cancer Center

Navin Robert Pinto
Ph: 773-834-7424

Navin Robert Pinto
Principal Investigator

University of Illinois

Mary Lou Schmidt
Ph: 312-355-3046

Mary Lou Schmidt
Principal Investigator

Oak Lawn

Advocate Children's Hospital-Oak Lawn

Rebecca Erin McFall
Ph: 847-723-7570

Rebecca Erin McFall
Principal Investigator

Peoria

Saint Jude Midwest Affiliate

Karen Sofia Fernandez
Ph: 309-655-3258

Karen Sofia Fernandez
Principal Investigator

Springfield

Southern Illinois University School of Medicine

Gregory P. Brandt
Ph: 217-545-7929

Gregory P. Brandt
Principal Investigator

Indiana
Indianapolis

Riley Hospital for Children

Robert J. Fallon
Ph: 317-274-2552

Robert J. Fallon
Principal Investigator

Saint Vincent Hospital and Health Services

Bassem I. Razzouk
Ph: 317-338-2194

Bassem I. Razzouk
Principal Investigator

Iowa
Des Moines

Blank Children's Hospital

Wendy Leigh Woods-Swafford
Ph: 515-241-6729

Wendy Leigh Woods-Swafford
Principal Investigator

Iowa City

University of Iowa/Holden Comprehensive Cancer Center

Ayman Ali El-Sheikh
Ph: 800-237-1225

Ayman Ali El-Sheikh
Principal Investigator

Kentucky
Louisville

Kosair Children's Hospital

Kenneth G. Lucas
Ph: 866-530-5516

Kenneth G. Lucas
Principal Investigator

Louisiana
New Orleans

Children's Hospital New Orleans

Lolie C. Yu
Ph: 504-894-5377

Lolie C. Yu
Principal Investigator

Maine
Scarborough

Maine Children's Cancer Program

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

Eric C. Larsen
Principal Investigator

Maryland
Baltimore

Johns Hopkins University/Sidney Kimmel Cancer Center

Allen R. Chen
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Allen R. Chen
Principal Investigator

Massachusetts
Boston

Dana-Farber Cancer Institute

Carlos Rodriguez-Galindo
Ph: 877-442-3324

Carlos Rodriguez-Galindo
Principal Investigator

Floating Hospital for Children at Tufts Medical Center

Michael J. Kelly
Ph: 617-636-5000
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

Michael J. Kelly
Principal Investigator

Massachusetts General Hospital Cancer Center

Howard Jeffrey Weinstein
Ph: 877-726-5130

Howard Jeffrey Weinstein
Principal Investigator

Springfield

Baystate Medical Center

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

Joanna G. Luty
Principal Investigator

Michigan
Ann Arbor

C S Mott Children's Hospital

Rajen Mody
Ph: 800-865-1125

Rajen Mody
Principal Investigator

Detroit

Saint John Hospital and Medical Center

Hadi Sawaf
Ph: 313-343-3166

Hadi Sawaf
Principal Investigator

Wayne State University/Karmanos Cancer Institute

Zhihong Joanne Wang
Ph: 313-576-9363

Zhihong Joanne Wang
Principal Investigator

Grand Rapids

Helen DeVos Children's Hospital at Spectrum Health

David Scott Dickens
Ph: 616-267-1925

David Scott Dickens
Principal Investigator

Kalamazoo

Bronson Methodist Hospital

Katharina Elisabeth Elliott
Ph: 800-227-2345

Katharina Elisabeth Elliott
Principal Investigator

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

Bruce Charles Bostrom
Ph: 612-813-5193

Bruce Charles Bostrom
Principal Investigator

University of Minnesota Medical Center-Fairview

Emily G. Greengard
Ph: 612-624-2620

Emily G. Greengard
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center

Gail Cranshaw Megason
Ph: 601-815-6700

Gail Cranshaw Megason
Principal Investigator

Missouri
Columbia

Columbia Regional

Thomas W. Loew
Ph: 573-882-7440

Thomas W. Loew
Principal Investigator

Kansas City

The Childrens Mercy Hospital

Maxine Lorraine Hetherington
Ph: 816-234-3265

Maxine Lorraine Hetherington
Principal Investigator

Saint Louis

Cardinal Glennon Children's Medical Center

William Shay Ferguson
Ph: 314-268-4000

William Shay Ferguson
Principal Investigator

Washington University School of Medicine

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

David Brian Wilson
Principal Investigator

Nebraska
Omaha

Children's Hospital and Medical Center of Omaha

Minnie Abromowitch
Ph: 402-955-3949

Minnie Abromowitch
Principal Investigator

University of Nebraska Medical Center

Minnie Abromowitch
Ph: 402-955-3949

Minnie Abromowitch
Principal Investigator

Nevada
Las Vegas

Children's Specialty Center of Nevada II

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Nevada Cancer Research Foundation CCOP

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

New Hampshire
Lebanon

Dartmouth Hitchcock Medical Center

Sara Chaffee
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

Sara Chaffee
Principal Investigator

New Jersey
Hackensack

Hackensack University Medical Center

Burton Eliot Appel
Ph: 201-996-2879

Burton Eliot Appel
Principal Investigator

Morristown

Morristown Medical Center

Steven Lon Halpern
Ph: 973-971-5900

Steven Lon Halpern
Principal Investigator

New Brunswick

Saint Peter's University Hospital

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

Stanley Calderwood
Principal Investigator

Newark

Newark Beth Israel Medical Center

Peri Kamalakar
Ph: 973-926-7230

Peri Kamalakar
Principal Investigator

Summit

Overlook Hospital

Steven Lon Halpern
Ph: 973-971-5900

Steven Lon Halpern
Principal Investigator

New Mexico
Albuquerque

University of New Mexico

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

Alice Lin-Tsing Yu
Principal Investigator

New York
Albany

Albany Medical Center

Vikramjit Singh Kanwar
Ph: 518-262-3368

Vikramjit Singh Kanwar
Principal Investigator

Bronx

Montefiore Medical Center - Moses Campus

Peter David Cole
Ph: 718-904-2730
Email: aecc@aecom.yu.edu

Peter David Cole
Principal Investigator

Buffalo

Roswell Park Cancer Institute

Meghan A. Higman
Ph: 877-275-7724

Meghan A. Higman
Principal Investigator

Mineola

Winthrop University Hospital

Mark E. Weinblatt
Ph: 866-946-8476

Mark E. Weinblatt
Principal Investigator

New Hyde Park

The Steven and Alexandra Cohen Children's Medical Center of New York

Jonathan D. Fish
Ph: 718-470-3470

Jonathan D. Fish
Principal Investigator

New York

Columbia University Medical Center

Alice Lee
Ph: 212-305-8615

Alice Lee
Principal Investigator

Laura and Issac Perlmutter Cancer Center at NYU Langone

Sharon Leigh Gardner
Ph: 212-263-4434
Email: prmc.coordinator@nyumc.org

Sharon Leigh Gardner
Principal Investigator

Rochester

University of Rochester

Jeffrey Robert Andolina
Ph: 585-275-5830

Jeffrey Robert Andolina
Principal Investigator

Syracuse

State University of New York Upstate Medical University

Karol Hicks Kerr
Ph: 315-464-5476

Karol Hicks Kerr
Principal Investigator

North Carolina
Asheville

Mission Hospital-Memorial Campus

Douglas James Scothorn
Ph: 828-213-4150

Douglas James Scothorn
Principal Investigator

Chapel Hill

University of North Carolina at Chapel Hill

Stuart Harrison Gold
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Stuart Harrison Gold
Principal Investigator

Charlotte

Carolinas Medical Center/Levine Cancer Institute

Joel A. Kaplan
Ph: 704-355-2884

Joel A. Kaplan
Principal Investigator

Novant Health Presbyterian Medical Center

Paulette Charese Bryant
Ph: 704-384-5369

Paulette Charese Bryant
Principal Investigator

Durham

Duke University Medical Center

Susan G. Kreissman
Ph: 888-275-3853

Susan G. Kreissman
Principal Investigator

North Dakota
Fargo

Sanford Medical Center-Fargo

Samuel Odame Anim
Ph: 701-234-6161

Samuel Odame Anim
Principal Investigator

Ohio
Akron

Children's Hospital Medical Center of Akron

Steven J. Kuerbitz
Ph: 330-543-3193

Steven J. Kuerbitz
Principal Investigator

Cincinnati

Cincinnati Children's Hospital Medical Center

John Peter Perentesis
Ph: 513-636-2799

John Peter Perentesis
Principal Investigator

Cleveland

Cleveland Clinic Foundation

Margaret C. Thompson
Ph: 866-223-8100

Margaret C. Thompson
Principal Investigator

Rainbow Babies and Childrens Hospital

Yousif (Joe) H. Matloub
Ph: 216-844-5437

Yousif (Joe) H. Matloub
Principal Investigator

Columbus

Nationwide Children's Hospital

Mark Anthony Ranalli
Ph: 614-722-2708

Mark Anthony Ranalli
Principal Investigator

Dayton

Dayton Children's Hospital

Emmett H. Broxson
Ph: 800-228-4055

Emmett H. Broxson
Principal Investigator

Toledo

The Toledo Hospital/Toledo Children's Hospital

Jamie L. Dargart
Ph: 419-824-1842

Jamie L. Dargart
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

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

Rene Yvonne McNall-Knapp
Principal Investigator

Oregon
Portland

Legacy Emanuel Children's Hospital

Janice Faye Olson
Ph: 503-413-2560

Janice Faye Olson
Principal Investigator

Legacy Emanuel Hospital and Health Center

Janice Faye Olson
Ph: 503-413-2560

Janice Faye Olson
Principal Investigator

Oregon Health and Science University

Susan Joy Lindemulder
Ph: 503-494-1080
Email: trials@ohsu.edu

Susan Joy Lindemulder
Principal Investigator

Pennsylvania
Danville

Geisinger Medical Center

Jagadeesh Ramdas
Ph: 570-271-5251

Jagadeesh Ramdas
Principal Investigator

Hershey

Penn State Hershey Children's Hospital

Lisa MacNabb McGregor
Ph: 717-531-6012

Lisa MacNabb McGregor
Principal Investigator

Philadelphia

Children's Hospital of Philadelphia

John M. Maris
Ph: 215-590-2810

John M. Maris
Principal Investigator

Saint Christopher's Hospital for Children

Akash Nahar
Ph: 215-427-8991

Akash Nahar
Principal Investigator

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Jean M. Tersak
Ph: 412-692-5573

Jean M. Tersak
Principal Investigator

South Carolina
Charleston

Medical University of South Carolina

Jacqueline M. Kraveka
Ph: 843-792-9321

Jacqueline M. Kraveka
Principal Investigator

Columbia

Palmetto Health Richland

Ronnie W. Neuberg
Ph: 803-434-3680

Ronnie W. Neuberg
Principal Investigator

Greenville

BI-LO Charities Children's Cancer Center

Nichole Leigh Bryant
Ph: 864-241-6251

Nichole Leigh Bryant
Principal Investigator

Greenville Cancer Treatment Center

Cary E. Stroud
Ph: 864-241-6251

Cary E. Stroud
Principal Investigator

South Dakota
Sioux Falls

Sanford USD Medical Center - Sioux Falls

Kayelyn Jean Wagner
Ph: 605-328-1367

Kayelyn Jean Wagner
Principal Investigator

Tennessee
Memphis

St. Jude Children's Research Hospital

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

Wayne Lee Furman
Principal Investigator

Nashville

Vanderbilt University/Ingram Cancer Center

Howard Mark Katzenstein
Ph: 800-811-8480

Howard Mark Katzenstein
Principal Investigator

Texas
Austin

Dell Children's Medical Center of Central Texas

Sharon Kay Lockhart
Ph: 512-324-8022

Sharon Kay Lockhart
Principal Investigator

Dallas

Medical City Dallas Hospital

Stanton Carl Goldman
Ph: 972-566-5588

Stanton Carl Goldman
Principal Investigator

UT Southwestern/Simmons Cancer Center-Dallas

Tanya Carens Watt
Ph: 214-648-7097

Tanya Carens Watt
Principal Investigator

Fort Worth

Cook Children's Medical Center

Mary Meaghan Petty Granger
Ph: 682-885-2103

Mary Meaghan Petty Granger
Principal Investigator

Houston

Baylor College of Medicine

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

Karen Ruth Rabin
Principal Investigator

San Antonio

Methodist Children's Hospital of South Texas

Jaime Estrada
Ph: 210-575-7000

Jaime Estrada
Principal Investigator

Utah
Salt Lake City

Primary Children's Hospital

Phillip Evan Barnette
Ph: 801-585-5270

Phillip Evan Barnette
Principal Investigator

Vermont
Burlington

University of Vermont College of Medicine

Alan Charles Homans
Ph: 802-656-4101

Alan Charles Homans
Principal Investigator

Virginia
Charlottesville

University of Virginia Cancer Center

Kimberly Panter Dunsmore
Ph: 434-243-6143

Kimberly Panter Dunsmore
Principal Investigator

Falls Church

Inova Fairfax Hospital

Marshall A. Schorin
Ph: 703-208-6650

Marshall A. Schorin
Principal Investigator

Norfolk

Childrens Hospital-King's Daughters

Eric Jeffrey Lowe
Ph: 757-668-7243

Eric Jeffrey Lowe
Principal Investigator

Portsmouth

Naval Medical Center - Portsmouth

Bethany Michelle Mikles
Ph: 757-953-5939

Bethany Michelle Mikles
Principal Investigator

Richmond

Virginia Commonwealth University/Massey Cancer Center

Gita Vasers Massey
Ph: 804-628-1939

Gita Vasers Massey
Principal Investigator

Washington
Seattle

Seattle Children's Hospital

Douglas S. Hawkins
Ph: 866-987-2000

Douglas S. Hawkins
Principal Investigator

Spokane

Providence Sacred Heart Medical Center and Children's Hospital

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

Judy L. Felgenhauer
Principal Investigator

West Virginia
Morgantown

West Virginia University Healthcare

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

Alice Lin-Tsing Yu
Principal Investigator

Wisconsin
Madison

University of Wisconsin Hospital and Clinics

Kenneth Brian DeSantes
Ph: 608-262-5223

Kenneth Brian DeSantes
Principal Investigator

Marshfield

Marshfield Clinic

Michael John McManus
Ph: 715-389-4457

Michael John McManus
Principal Investigator

Milwaukee

Midwest Children's Cancer Center

Michael Edward Kelly
Ph: 414-805-4380

Michael Edward Kelly
Principal Investigator

Australia

Herston

Royal Brisbane and Women's Hospital

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

Helen Irving
Principal Investigator

Hunter Regional Mail Centre

John Hunter Children's Hospital

Geoffrey Brian McCowage
Ph: 61-2-9845 1400

Geoffrey Brian McCowage
Principal Investigator

Parkville

Royal Children's Hospital

Francoise Marie Mechinaud
Email: crdo.info@mcri.edu.au

Francoise Marie Mechinaud
Principal Investigator

Perth

Princess Margaret Hospital for Children

Catherine Helen Cole
Ph: (08) 9340 8222
Email: catherine.cole@health.wa.gov.au

Catherine Helen Cole
Principal Investigator

Randwick

Sydney Children's Hospital

Draga Barbaric
Ph: (02) 9382-1721

Draga Barbaric
Principal Investigator

South Brisbane

Lady Cilento Children's Hospital

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

Helen Irving
Principal Investigator

Westmead

The Children's Hospital at Westmead

Geoffrey Brian McCowage
Ph: 61-2-9845 1400

Geoffrey Brian McCowage
Principal Investigator

Canada

Alberta
Calgary

Alberta Children's Hospital

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

Douglas R. Strother
Principal Investigator

Edmonton

University of Alberta Hospital

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

Sunil Jayantilal Sunderlal Desai
Principal Investigator

British Columbia
Vancouver

British Columbia Children's Hospital

Caron Strahlendorf
Ph: 604-875-2345ext6477

Caron Strahlendorf
Principal Investigator

Manitoba
Winnipeg

CancerCare Manitoba

Rochelle Avis Yanofsky
Ph: 866-561-1026
Email: CIO_Web@cancercare.mb.ca

Rochelle Avis Yanofsky
Principal Investigator

Newfoundland and Labrador
Saint John's

Janeway Child Health Centre

Lisa Anne Beresford Goodyear
Ph: 866-722-1126

Lisa Anne Beresford Goodyear
Principal Investigator

Nova Scotia
Halifax

IWK Health Centre

Conrad Vincent Fernandez
Ph: 902-470-8394

Conrad Vincent Fernandez
Principal Investigator

Ontario
Hamilton

Chedoke Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100ext74595

Carol Portwine
Principal Investigator

McMaster Children's Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100ext74595

Carol Portwine
Principal Investigator

London

Children's Hospital

Shayna M. Zelcer
Ph: 519-685-8306

Shayna M. Zelcer
Principal Investigator

Ottawa

Children's Hospital of Eastern Ontario

Jacqueline Mary Lewis Halton
Ph: 613-738-3931

Jacqueline Mary Lewis Halton
Principal Investigator

Toronto

Hospital for Sick Children

Meredith S. Irwin
Ph: 416-813-7654ext2027
Email: jason.mcguire@sickkids.ca

Meredith S. Irwin
Principal Investigator

Quebec
Montreal

Centre Hospitalier Universitaire Sainte-Justine

Yvan Samson
Ph: 514-345-4931

Yvan Samson
Principal Investigator

The Montreal Children's Hospital of the MUHC

Sharon Barbara Abish
Ph: 514-412-4445
Email: info@thechildren.com

Sharon Barbara Abish
Principal Investigator

Quebec

Centre Hospitalier Universitaire de Quebec

Bruno Michon
Ph: 418-525-4444

Bruno Michon
Principal Investigator

New Zealand

Christchurch

Christchurch Hospital

Siobhan Frances Cross
Ph: 03 364 0640

Siobhan Frances Cross
Principal Investigator

Grafton

Starship Children's Hospital

Mark Andrew Winstanley
Ph: 0800 728 436

Mark Andrew Winstanley
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00026312

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.