Irinotecan Hydrochloride and Temozolomide with Temsirolimus or Dinutuximab in Treating Younger Patients with Refractory or Relapsed Neuroblastoma

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActiveChildrenANBL1221
NCI-2012-03125, CDR0000745188, COG-ANBL1221, PANBL1221_A08PAMDREVW01, NCT01767194

Trial Description

Summary

This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, 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. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving irinotecan hydrochloride and temozolomide together with temsirolimus or dinutuximab is more effective in treating neuroblastoma.

Further Study Information

PRIMARY OBJECTIVES:

I. To identify whether temsirolimus or ch14.18 (dinutuximab) is the optimal therapeutic agent to consider for further testing in a future Phase III randomized trial for treatment of newly diagnosed high-risk neuroblastoma.

II. To determine the response rate of patients with relapsed, refractory or progressive neuroblastoma following treatment with irinotecan, temozolomide and ch14.18 (dinutuximab) and to compare this with the known response rate of patients treated with irinotecan and temozolomide alone.

SECONDARY OBJECTIVES:

I. To compare the response rates (RR) for patients receiving temsirolimus or ch14.18 (dinutuximab) in combination with irinotecan (irinotecan hydrochloride) and temozolomide.

II. To compare the progression free survival (PFS) and overall survival (OS) rates for patients receiving temsirolimus or ch14.18 (dinutuximab) in combination with irinotecan and temozolomide.

III. To compare the toxicities associated with temsirolimus or ch14.18 (dinutuximab) when combined with irinotecan and temozolomide in patients with refractory, relapsed or progressive neuroblastoma.

IV. To compare the ability to maintain intended dose intensity of all agents when temsirolimus or ch14.18 (dinutuximab) is combined with irinotecan and temozolomide in patients with refractory, relapsed or progressive neuroblastoma.

V. To determine the concordance between tumor responses as defined by standard International Neuroblastoma Response Criteria (INRC) versus response per the revised INRC.

VI. To study the clinical relevance of naturally occurring anti-glycan antibodies in patients receiving ch14.18 (dinutuximab) antibody.

VII. To study the clinical relevance of natural killer (NK) receptor natural cytotoxicity triggering receptor 3 (NKp30) isoforms in patients receiving ch14.18 (dinutuximab) antibody or temsirolimus.

VIII. To study the association between host factors and response to irinotecan, temozolomide and ch14.18 (dinutuximab).

IX. To characterize the tumor immune-microenvironment (gene expression; immune effector cells, activities and signaling molecules; immune target expression) following treatment with irinotecan, temozolomide and ch14.18 (dinutuximab).

X. To study the association between changes in the tumor immune-microenvironment (gene expression; immune effector cells, activities and signaling molecules; immune target expression) with response following treatment with irinotecan, temozolomide and ch14.18 (dinutuximab).

XI. To study the association between tumor genomic and transcriptomic aberrations as well as levels of circulating ganglioside (GD2) with response to irinotecan, temozolomide and ch14.18 (dinutuximab).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I (CLOSED TO ACCRUAL 06/17/2016): Patients receive temozolomide orally (PO) on days 1-5, irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8.

ARM II: Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim subcutaneously (SC) or IV over 2 hours on days 6-12.

In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

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

Eligibility Criteria

Inclusion Criteria:

Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines (i.e., > 2 x upper limit of normal [ULN]), at the time of initial diagnosis

For the purposes of this study, aggressive multidrug chemotherapy is defined as chemotherapy including 2 or more agents that must include an alkylating agent and a platinum-containing compound; patients must have ONE of the following:

First episode of recurrent disease following completion of aggressive multi-drug frontline therapy

First episode of progressive disease during aggressive multi-drug frontline therapy

Primary resistant/refractory disease (less than partial response by INRC) detected at the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (examples include A3973, ANBL0532, ANBL09P1, etc.)

Patients must have at least ONE of the following:

Measurable tumor on magnetic resonance imaging (MRI), computed tomography (CT) scan obtained within 3 weeks prior to study entry; measurable is defined as >= 10 mm in at least one dimension on spiral/helical CT that is metaiodobenzylguanidine (MIBG) avid or demonstrates increased fludeoxyglucose (FDG) uptake on positron emission tomography (PET) scan

MIBG scan obtained within 3 weeks prior to study entry with positive uptake at a minimum of one site; this site must represent disease recurrence after completion of therapy, progressive disease on therapy, or refractory disease during induction

Patients with resistant/refractory soft tissue disease that is not MIBG avid or does not demonstrate increased FDG uptake on PET scan must undergo biopsy to document the presence of viable neuroblastoma; biopsy is not required for patients who have new site of soft tissue disease (radiographic evidence of disease progression) regardless of whether progression occurs while receiving therapy or after completion of therapy

Note: Patients with elevated catecholamines (i.e., > 2 x ULN) only or bone marrow disease only are NOT eligible for this study

Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

Patients must have received frontline therapy (including surgery, chemotherapy, autologous stem cell transplant [SCT] +/- MIBG, immunotherapy, radiotherapy, and retinoids) but may NOT have received second line chemotherapy for resistant/refractory, relapsed disease or progressive disease

At least 14 days must have elapsed since completion of myelosuppressive therapy

At least 7 days must have elapsed since the completion of therapy with a non-myelosuppressive biologic agent or retinoid

No interim time prior to study entry is required following prior radiation therapy (RT) for non-target lesions; however, patients must not have received radiation for a minimum of 4 weeks prior to study entry at the site of any lesion that will be identified as a target lesion to measure tumor response; lesions that have been previously radiated cannot be used as target lesions unless there is radiographic evidence of progression at the site following radiation or a biopsy done following radiation shows viable neuroblastoma; palliative radiation is allowed to sites that will not be used to measure response during this study

Patients are eligible >= 6 weeks after autologous stem cell transplants or stem cell infusions as long as hematologic and other eligibility criteria have been met

Patients are eligible >= 6 weeks after therapeutic 131I-MIBG provided that all other eligibility criteria are met

Subjects who have previously received anti-GD2 monoclonal antibodies for biologic therapy or for tumor imaging are eligible unless they have had progressive disease while receiving prior anti-GD2 therapy; subjects who have received autologous marrow infusions or autologous stem cell infusions that were purged using monoclonal antibody linked to beads, but no other form of anti-GD2 monoclonal antibody, are eligible

Patients must not have received long-acting myeloid growth factors (e.g., Neulasta) within 14 days of entry on this study; seven days must have elapsed since administration of a short acting myeloid growth factor

Peripheral absolute neutrophil count (ANC) >= 750/uL

Platelet count >= 75,000/uL (transfusion independent)

Patients known to have bone marrow involvement with neuroblastoma are eligible provided that minimum ANC and platelet count criteria are met but are not evaluable for hematological toxicity

Creatinine clearance or estimated radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or

A serum creatinine =< upper limit of normal (ULN) based on age/gender as follows:

Age 1 month to < 6 months: 0.4 for males, 0.4 for females

Age 6 months to < 1 year: 0.5 for males, 0.5 for females

Age 1 to < 2 years: 0.6 for males, 0.6 for females

Age 2 to < 6 years: 0.8 for males, 0.8 for females

Age 6 to < 10 years: 1 for males, 1 for females

Age 10 to < 13 years: 1.2 for males, 1.2 for females

Age 13 to < 16 years: 1.5 for males, 1.4 for females

Age >= 16 years: 1.7 for males, 1.4 for females

Total bilirubin =< 1.5 x ULN for age AND

Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5.0 x ULN for age (=< 225 U/L); for the purpose of this study, the ULN for SGPT is 45 U/L

Adequate central nervous system function defined as:

Patients with a history of central nervous system (CNS) disease must have no clinical or radiological evidence of CNS disease at the time of study enrollment

Patients with seizure disorders may be enrolled if seizures are well controlled on anticonvulsants

CNS toxicity =< grade 2

Shortening fraction of >= 27% by echocardiogram (ECHO) OR

Ejection fraction >= 50% by ECHO or gated radionuclide study

Adequate coagulation defined as:

Prothrombin time (PT) =< 1.2 x upper limit of normal

Adequate pulmonary function defined as:

No evidence of dyspnea at rest, no exercise intolerance, no chronic oxygen requirement, and room air pulse oximetry > 94% if there is a clinical indication for pulse oximetry; normal pulmonary function tests in patients who are capable of cooperating with testing (including diffusion capacity of the lung of carbon monoxide [DLCO]) are required if there is a clinical indication for determination; for patients who do not have respiratory symptoms, full pulmonary function tests (PFTs) are NOT required

Exclusion Criteria:

Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study; based on the established teratogenic potential of alkylating agents, pregnant women will be excluded from this study; female patients who are lactating must agree to stop breastfeeding or will otherwise be excluded from this study; females of childbearing potential must have a negative pregnancy test to be eligible for this study

Patients with elevated catecholamines (i.e., > 2 x ULN) only or bone marrow disease only are NOT eligible for this study

Patients must have been off pharmacologic doses of systemic steroids for at least 7 days prior to enrollment; patients who require or are likely to require pharmacologic doses of systemic corticosteroids while receiving treatment on this study are ineligible; the only exception is for patients known to require 2 mg/kg or less of hydrocortisone (or an equivalent dose of an alternative corticosteroid) as premedication for blood product administration in order to avoid allergic transfusion reactions; the use of conventional doses of inhaled steroids for the treatment of asthma is permitted, as is the use of physiologic doses of steroids for patients with known adrenal insufficiency

Patients must not have received enzyme-inducing anticonvulsants including phenytoin, phenobarbital, valproic acid, or carbamazepine for at least 7 days prior to study enrollment; patients receiving non-enzyme inducing anticonvulsants such as gabapentin or levetiracetam will be eligible

Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma

Patients with symptoms of congestive heart failure are not eligible

Patients must not have >= grade 2 diarrhea

Patients must not have uncontrolled infection

Patients with a history of grade 4 allergic reactions to anti-GD2 antibodies or reactions that required discontinuation of the anti-GD2 therapy are not eligible

Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of study agents or to significantly increase the severity of the toxicities experienced from study treatment are not eligible

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

National Cancer Institute

  • National Cancer Institute
Rajen Mody, Principal Investigator

Trial Sites

U.S.A.

Arizona
Phoenix

Phoenix Childrens Hospital

Jessica Boklan
Ph: 602-546-0920

Jessica Boklan
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

Loma Linda

Loma Linda University Medical Center

Albert Kheradpour
Ph: 909-558-3375

Albert Kheradpour
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

Kaiser Permanente-Oakland

Steven K. Bergstrom
Ph: 626-564-3455

Steven K. Bergstrom
Principal Investigator

Orange

Children's 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

Yung Soon Yim
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Yung Soon Yim
Principal Investigator

University of California Davis Comprehensive Cancer Center

Marcio Henrique Malogolowkin
Ph: 916-734-3089

Marcio Henrique Malogolowkin
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

Katherine Kurshan Matthay
Ph: 877-827-3222

Katherine Kurshan Matthay
Principal Investigator

Colorado
Aurora

Children's Hospital Colorado

Margaret Ellen Macy
Ph: 720-777-6672

Margaret Ellen Macy
Principal Investigator

Denver

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Jennifer Jocelyn Clark
Ph: 866-775-6246

Jennifer Jocelyn Clark
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

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Ramamoorthy Nagasubramanian
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

Aziza Tahir Shad
Ph: 202-444-0381

Aziza Tahir Shad
Principal Investigator

Florida
Fort Myers

Golisano Children's Hospital of Southwest Florida

Emad K. Salman
Ph: 239-343-5333

Emad K. Salman
Principal Investigator

Gainesville

University of Florida

William Birdsall Slayton
Ph: 352-273-8675
Email: trials@cancer.ufl.edu

William Birdsall Slayton
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

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Ramamoorthy Nagasubramanian
Principal Investigator

Miami

Nicklaus Children's Hospital

Enrique Alberto Escalon
Ph: 888-624-2778

Enrique Alberto Escalon
Principal Investigator

University of Miami Miller School of Medicine-Sylvester Cancer Center

Julio Cesar Barredo
Ph: 305-243-2647

Julio Cesar Barredo
Principal Investigator

Orlando

Florida Hospital Orlando

Fouad M. Hajjar
Ph: 407-303-2090
Email: FH.Cancer.Research@flhosp.org

Fouad M. Hajjar
Principal Investigator

Nemours Children's Hospital

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Ramamoorthy Nagasubramanian
Principal Investigator

Pensacola

Nemours Children's Clinic - Pensacola

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Ramamoorthy Nagasubramanian
Principal Investigator

Saint Petersburg

Johns Hopkins 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

Mark J. Mogul
Ph: 800-882-4123

Mark J. Mogul
Principal Investigator

Georgia
Atlanta

Children's Healthcare of Atlanta - Egleston

Kelly C. Goldsmith
Ph: 888-785-1112

Kelly C. Goldsmith
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

Wade T. Kyono
Ph: 808-983-6090

Wade T. Kyono
Principal Investigator

Idaho
Boise

Saint Luke's Mountain States Tumor Institute

Eugenia Chang
Ph: 208-381-3376
Email: mcdonagd@slhs.org

Eugenia Chang
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

Susan Lerner Cohn
Ph: 773-834-7424

Susan Lerner Cohn
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

Pedro A. De Alarcon
Ph: 309-655-3258

Pedro A. De Alarcon
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: 800-248-1199

Robert J. Fallon
Principal Investigator

Saint Vincent Hospital and Health Care Center

Bassem I. Razzouk
Ph: 317-338-2194
Email: research@stvincent.org

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

Mariko Sato
Ph: 800-237-1225

Mariko Sato
Principal Investigator

Kentucky
Lexington

University of Kentucky/Markey Cancer Center

Lars Martin Wagner
Ph: 859-257-3379

Lars Martin Wagner
Principal Investigator

Louisville

Norton 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

Ochsner Medical Center Jefferson

Craig Lotterman
Ph: 888-562-4763

Craig Lotterman
Principal Investigator

Maine
Bangor

Eastern Maine Medical Center

Sam Wei Lew
Ph: 800-987-3005

Sam Wei Lew
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

Sinai Hospital of Baltimore

Jason M. Fixler
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

Jason M. Fixler
Principal Investigator

Massachusetts
Boston

Dana-Farber Cancer Institute

Suzanne Shusterman
Ph: 877-442-3324

Suzanne Shusterman
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

East Lansing

Michigan State University Clinical Center

Renuka Gera
Ph: 517-975-9547

Renuka Gera
Principal Investigator

Grand Rapids

Helen DeVos Children's Hospital at Spectrum Health

David Scott Dickens
Ph: 616-391-1230
Email: crcwm-regulatory@crcwm.org

David Scott Dickens
Principal Investigator

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

Michael Kerr Richards
Ph: 612-813-5193

Michael Kerr Richards
Principal Investigator

University of Minnesota/Masonic Cancer Center

Emily G. Greengard
Ph: 612-624-2620

Emily G. Greengard
Principal Investigator

Rochester

Mayo Clinic

Carola A. S. Arndt
Ph: 855-776-0015

Carola A. S. Arndt
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center

Gail Cranshaw Megason
Ph: 601-815-6700

Gail Cranshaw Megason
Principal Investigator

Missouri
Kansas City

The Childrens Mercy Hospital

Keith Jason August
Ph: 816-234-3265

Keith Jason August
Principal Investigator

Saint Louis

Mercy Hospital Saint Louis

Bethany Graham Sleckman
Ph: 913-948-5588

Bethany Graham Sleckman
Principal Investigator

Washington University School of Medicine

Robert J. Hayashi
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Robert J. Hayashi
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

Alan K. Ikeda
Ph: 702-384-0013

Alan K. Ikeda
Principal Investigator

Nevada Cancer Research Foundation CCOP

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Summerlin Hospital Medical Center

Alan K. Ikeda
Ph: 702-384-0013

Alan K. Ikeda
Principal Investigator

Sunrise Hospital and Medical Center

Alan K. Ikeda
Ph: 702-384-0013

Alan K. Ikeda
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

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

Richard A. Drachtman
Ph: 732-235-8675

Richard A. Drachtman
Principal Investigator

New Mexico
Albuquerque

University of New Mexico Cancer Center

Koh B. Boayue
Ph: 505-925-0366
Email: LByatt@nmcca.org

Koh B. Boayue
Principal Investigator

New York
Albany

Albany Medical Center

Vikramjit Singh Kanwar
Ph: 518-262-3368

Vikramjit Singh Kanwar
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/Herbert Irving Cancer Center

Alice Lee
Ph: 212-305-8615

Alice Lee
Principal Investigator

Syracuse

State University of New York Upstate Medical University

Melanie A. Comito
Ph: 315-464-5476

Melanie A. Comito
Principal Investigator

Valhalla

New York Medical College

Jessica Cassara Hochberg
Ph: 914-594-3794

Jessica Cassara Hochberg
Principal Investigator

North Carolina
Asheville

Mission Hospital-Memorial Campus

Douglas James Scothorn
Ph: 828-213-4150

Douglas James Scothorn
Principal Investigator

Chapel Hill

UNC Lineberger Comprehensive Cancer Center

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

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

Brian David Weiss
Ph: 513-636-2799

Brian David Weiss
Principal Investigator

Cleveland

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

Ayman Ali El-Sheikh
Ph: 800-228-4055

Ayman Ali El-Sheikh
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: 405-271-8777
Email: ou-clinical-trials@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

Oregon Health and Science University

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

Susan Joy Lindemulder
Principal Investigator

Pennsylvania
Hershey

Penn State Children's Hospital

Lisa MacNabb McGregor
Ph: 717-531-6012

Lisa MacNabb McGregor
Principal Investigator

Philadelphia

Children's Hospital of Philadelphia

Rochelle Bagatell
Ph: 215-590-2810

Rochelle Bagatell
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

Puerto Rico
San Juan

San Jorge Children's Hospital

Luis A. Clavell
Ph: 787-727-1000

Luis A. Clavell
Principal Investigator

South Carolina
Columbia

Palmetto Health Richland

Ronnie W. Neuberg
Ph: 803-434-3680

Ronnie W. Neuberg
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
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

Amy Catherine Fowler
Ph: 214-648-7097

Amy Catherine Fowler
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

Lubbock

Covenant Children's Hospital

Kishor Mallikarjun Bhende
Ph: 806-775-8590

Kishor Mallikarjun Bhende
Principal Investigator

San Antonio

Children's Hospital of San Antonio

Timothy C. Griffin
Ph: 800-248-1199

Timothy C. Griffin
Principal Investigator

Methodist Children's Hospital of South Texas

Gerardo Quezada
Ph: 210-575-7000

Gerardo Quezada
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

William Carl Petersen
Ph: 434-243-6322
Email: JME3D@hscmail.mcc.virginia.edu

William Carl Petersen
Principal Investigator

Norfolk

Childrens Hospital-King's Daughters

Eric Jeffrey Lowe
Ph: 757-668-7243

Eric Jeffrey Lowe
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

Stephan R. Paul
Ph: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu

Stephan R. Paul
Principal Investigator

Wisconsin
Madison

University of Wisconsin Hospital and Clinics

Kenneth Brian De Santes
Ph: 715-422-7718

Kenneth Brian De Santes
Principal Investigator

Marshfield

Marshfield Clinic

Michael John McManus
Ph: 715-389-4457

Michael John McManus
Principal Investigator

Milwaukee

Children's Hospital of Wisconsin

Michael Edward Kelly
Ph: 414-805-4380

Michael Edward Kelly
Principal Investigator

Australia

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

South Brisbane

Lady Cilento Children's Hospital

Helen Irving
Ph: 1300 762 831

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: 780-407-8798

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

John Joseph Doyle
Ph: 866-561-1026
Email: CIO_Web@cancercare.mb.ca

John Joseph Doyle
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

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

Sarah Weeks Alexander
Ph: 416-813-7654ext2027
Email: jason.mcguire@sickkids.ca

Sarah Weeks Alexander
Principal Investigator

Quebec
Montreal

Centre Hospitalier Universitaire Sainte-Justine

Yvan Samson
Ph: 514-345-4931

Yvan Samson
Principal Investigator

Quebec

Centre Hospitalier Universitaire de Quebec

Bruno Michon
Ph: 888-823-5923
Email: ctsucontact@westat.com

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 Identifier NCT01767194

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.