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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase III, Phase IIBiomarker/Laboratory analysis, Treatment18 and underANHL1131
NCI-2012-01963, 2010-019224-31, CDR0000732604, IGR2009/1593, COG-ANHL1131, NCT01595048

Trial Description

Summary

This randomized phase II/III trial studies how well combination chemotherapy with or without rituximab works in treating younger patients with stage III-IV non-Hodgkin lymphoma or B-cell acute leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibody, such as rituximab, may block cancer growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy together with rituximab is more effective in treating patients with non-Hodgkin lymphoma or B-cell acute leukemia.

Further Study Information

PRIMARY OBJECTIVES:

I. For the patients with advanced stage B-cell non-Hodgkin lymphoma (NHL)/Burkitt acute leukemia (B-AL) (stage III and lactate dehydrogenase (LDH) > twice the institutional upper limit of the adult normal values (Nx2), any stage IV or B-AL), to test whether adding 6 injections of rituximab to standard Lymphome Malin B (LMB) chemotherapy regimen, improves the event-free survival (EFS) compared with LMB chemotherapy alone. (Phase III)

II. For patients with primary mediastinal large B-cell lymphoma (PMLBL), to evaluate the EFS following treatment with the regimen dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride (DA-EPOCH)-rituximab. (Phase II)

SECONDARY OBJECTIVES:

I. To study the complete remission (CR) rate and the overall survival (OS).

II. To evaluate safety on all study arms including toxic deaths, adverse events recorded using the National Cancer Institute (NCI)-Common Terminology Criteria (CTC) version (V)4 (non hematological toxicity grade >= 3, infections grade 3 to 5), cardiac toxicity (CTC grade 2-5 and evolution of left ventricular ejection fraction and left ventricular shortening fraction), number of days with platelets transfusion, intensive care unit admission and number of days with red cells transfusion, rituximab infusion reactions.

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

IV. To study long term (at least 5 years) risks of the use of rituximab plus chemotherapy compared with LMB chemotherapy alone in children and adolescents with advanced stage B-NHL/B-AL (all events related [certain and probable] to therapy). (Phase III)

V. To study the long term risk of DA-EPOCH-R regimen, especially the cardiac risk related to doxorubicin given at higher dose than usual in children, but infused over 96 hours (i.e., evaluation of CTC grade 2-5 and evolution of left ventricular ejection fraction and left ventricular shortening fraction). (Phase II)

TERTIARY OBJECTIVES:

I. To obtain data on positron emission tomography (PET)-computed tomography (CT) scan in childhood pediatric B-cell NHL. (Exploratory)

II. To evaluate the potential prognostic value of Minimal Disseminated Disease (MDD) and Minimal Residual disease (MRD) in correlation with outcome. (Exploratory - Phase III)

III. To perform an economic study comparing the cost-effectiveness ratio between 2 therapeutic strategies: LMB chemotherapy with versus LMB chemotherapy without rituximab. (Exploratory - Phase III)

IV. To characterize the pharmacokinetics of rituximab in combination with LMB chemotherapy in a subset of patients. (Exploratory - Phase III)

OUTLINE:

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

Phase III:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Eligibility Criteria

Inclusion Criteria:

Histolo-cytologically proven PMLBL (phase II)

PMLBL without central nervous system (CNS) involvement

Slides will be reviewed by the national pathology panel, but review is not mandatory before registration

Histologically or cytologically proven B-cell malignancies; either Burkitt leukemia or B-AL (= Burkitt leukemia = L3-AL), or diffuse large B-cell NHL, or aggressive mature B-cell NHL non otherwise specified or specifiable (phase III)

Stage III with elevated LDH level (B-high) (LDH > twice the institutional upper limit of the adult normal values [> Nx2]), any stage IV, or B-AL (phase III)

Able to comply with scheduled follow-up and with management of toxicity

Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate

Signed informed consent from patients and/or their parents or legal guardians

Complete initial work-up within 8 days prior to treatment that allows definite staging

Exclusion Criteria:

Hepatitis B carrier status history of hepatitis B virus (HBV) or positive serology; a patient is considered as HBV carrier or to have (had) HBV infection in case of:

Unimmunized and hepatitis B surface antigen (HBsAg) and/or anti-HBs antibody and/or anti- HBc antibody positive,

Immunized and HBsAG and/or anti-HBc antibody positive

  • Important note: for the phase III trial, a patient without a known history of hepatitis B could be randomized in the study if the serology results are not available at the time of the randomization; however, if the serology results are positive or not available at day 6 (the first day would be due to receive rituximab, if so randomized), the patient must be withdrawn from the study whatever the allocated treatment arm; the data center must be informed immediately; for the phase II trial, the hepatitis B serology results must be available before registration; in each case indicating a carrier status or history for hepatitis B infection, the patients must not receive rituximab, and therefore must not be included in the rituximab trials on any treatment arm; in case of high-risk patients, the recommendation is to treat these patients with the standard LMB regimen corresponding to the patient prognostic group; in the case of PMLBL the physician is left to choose the most appropriate therapy

There will be no exclusion criteria based on organ function

Evidence of pregnancy or lactation period

Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive human immunodeficiency virus (HIV) serology

Patients who, for any reason, are not able to comply with the national legislation

Participation in another investigational drug clinical trial

In phase II study (PMLBL) patients with CNS involvement are not eligible

Follicular lymphoma, Mucosa-Associated Lymphoid Tissue (MALT) and nodular marginal zone are not included into this therapeutic study

Past or current anti-cancer treatment except corticosteroids of less than 7 days duration in total

Severe active viral infection, especially hepatitis B; severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of randomization; contact the national co-investigator for further advice if necessary

Prior exposure to rituximab

Tumor cell negative for cluster of differentiation (CD)20 (absence of result due to technical problems in the presence of other characteristics suggestive of BL/DLBCL, including genetic and phenotypic features, is not an exclusion criteria)

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Children's Oncology Group

  • National Cancer Institute
Thomas Gene Gross, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

Children's Hospital of Alabama

Alyssa Terry Reddy
Ph: 888-823-5923
Email: ctsucontact@westat.com

Alyssa Terry Reddy
Principal Investigator

Mobile

University of South Alabama

Felicia Little Wilson
Ph: 251-665-8000

Felicia Little Wilson
Principal Investigator

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

Duarte

City of Hope Comprehensive Cancer Center

Theresa Marie Harned
Ph: 800-826-4673
Email: becomingapatient@coh.org

Theresa Marie Harned
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

Cecilia Hsing-I Fu
Ph: 323-361-4110

Cecilia Hsing-I Fu
Principal Investigator

Los Angeles

Cedars-Sinai Medical Center

Fataneh (Fae) Majlessipour
Ph: 310-423-8965

Fataneh (Fae) Majlessipour
Principal Investigator

Children's Hospital Los Angeles

Leo Mascarenhas
Ph: 323-361-4110

Leo Mascarenhas
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

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

Yung Soon Yim
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

Michelle Lynn Hermiston
Ph: 877-827-3222

Michelle Lynn Hermiston
Principal Investigator

Torrance

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Joseph L. Lasky
Ph: 888-662-8252

Joseph L. Lasky
Principal Investigator

Colorado
Aurora

Children's Hospital Colorado

Kelly Wilson Maloney
Ph: 720-777-6672

Kelly Wilson Maloney
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

Jeffrey H. Schwartz
Ph: 904-697-3529

Jeffrey H. Schwartz
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

Jacksonville

Nemours Children's Clinic-Jacksonville

Jeffrey H. Schwartz
Ph: 904-697-3529

Jeffrey H. Schwartz
Principal Investigator

Miami

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

Nemours Children's Hospital

Jeffrey H. Schwartz
Ph: 904-697-3529

Jeffrey H. Schwartz
Principal Investigator

Pensacola

Nemours Children's Clinic - Pensacola

Jeffrey H. Schwartz
Ph: 904-697-3529

Jeffrey H. Schwartz
Principal Investigator

Saint Petersburg

All Children's Hospital

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

Gregory Alan Hale
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

Howard Mark Katzenstein
Ph: 800-811-8480

Howard Mark Katzenstein
Principal Investigator

Augusta

Georgia Regents University Medical Center

Colleen H. McDonough
Ph: 706-721-1663
Email: cancer@georgiahealth.edu

Colleen H. McDonough
Principal Investigator

Savannah

Memorial University Medical Center

J. Martin Johnston
Ph: 912-350-8568

J. Martin Johnston
Principal Investigator

Hawaii
Honolulu

University of Hawaii Cancer Center

Robert W. Wilkinson
Ph: 808-983-6090

Robert W. Wilkinson
Principal Investigator

Idaho
Boise

Saint Luke's Mountain States Tumor Institute

Eugenia Chang
Ph: 800-845-4624

Eugenia Chang
Principal Investigator

Illinois
Chicago

Lurie Children's Hospital-Chicago

Joanna Lynn Weinstein
Ph: 773-880-4562

Joanna Lynn Weinstein
Principal Investigator

University of Illinois

Mary Lou Schmidt
Ph: 312-355-3046

Mary Lou Schmidt
Principal Investigator

Maywood

Loyola University Medical Center

Eugene Suh
Ph: 708-226-4357

Eugene Suh
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: 888-823-5923
Email: ctsucontact@westat.com

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
Lexington

University of Kentucky/Markey Cancer Center

Lars Martin Wagner
Ph: 859-257-3379

Lars Martin Wagner
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
Scarborough

Maine Children's Cancer Program

Aaron Robert Weiss
Ph: 207-396-8090
Email: wrighd@mmc.org

Aaron Robert Weiss
Principal Investigator

Maryland
Baltimore

Johns Hopkins University/Sidney Kimmel Cancer Center

Kenneth J. Cohen
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Kenneth J. Cohen
Principal Investigator

Sinai Hospital of Baltimore

Joseph M. Wiley
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

Joseph M. Wiley
Principal Investigator

Bethesda

Walter Reed National Military Medical Center

Anne Benedicta Warwick
Ph: 301-319-2100

Anne Benedicta Warwick
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

Worcester

University of Massachusetts Medical School

Christopher P. Keuker
Ph: 508-856-3216
Email: cancer.research@umassmed.edu

Christopher P. Keuker
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

Meret Henry
Ph: 313-576-9363

Meret Henry
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: 616-267-1925

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

Rochester

Mayo Clinic

Paul John Galardy
Ph: 507-538-7623

Paul John Galardy
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

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

Nik Farahana Nik Abdul Rashid
Ph: 702-384-0013

Nik Farahana Nik Abdul Rashid
Principal Investigator

Nevada Cancer Research Foundation CCOP

Nik Farahana Nik Abdul Rashid
Ph: 702-384-0013

Nik Farahana Nik Abdul Rashid
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

UMDNJ - Robert Wood Johnson University Hospital

Richard A. Drachtman
Ph: 732-235-8675

Richard A. Drachtman
Principal Investigator

Newark

Newark Beth Israel Medical Center

Stacey Rifkin-Zenenberg
Ph: 973-322-2470

Stacey Rifkin-Zenenberg
Principal Investigator

Paterson

Saint Joseph's Regional Medical Center

Mary Ann Bonilla
Ph: 973-754-2909

Mary Ann Bonilla
Principal Investigator

New Mexico
Albuquerque

University of New Mexico

Thomas Gene Gross
Ph: 614-722-3515
Email: Thomas.Gross@nationwidechildrens.org

Thomas Gene Gross
Principal Investigator

University of New Mexico Cancer Center

Koh B. Boayue
Ph: 505-272-6972

Koh B. Boayue
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

Martin Louis Brecher
Ph: 877-275-7724

Martin Louis Brecher
Principal Investigator

Mineola

Winthrop University Hospital

Mark E. Weinblatt
Ph: 866-946-8476

Mark E. Weinblatt
Principal Investigator

New York

Columbia University Medical Center

Alice Lee
Ph: 212-305-8615

Alice Lee
Principal Investigator

Mount Sinai Medical Center

Birte Wistinghausen
Ph: 212-824-7320
Email: jenny.figueroa@mssm.edu

Birte Wistinghausen
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

Winston-Salem

Wake Forest University Health Sciences

Thomas Williams McLean
Ph: 336-713-6771

Thomas Williams McLean
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

Johannes Ernst Alexander Wolff
Ph: 866-223-8100

Johannes Ernst Alexander Wolff
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

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

Ayman Ali El-Sheikh
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

Oregon Health and Science University

Linda Claudette Stork
Ph: 503-494-1080
Email: trials@ohsu.edu

Linda Claudette Stork
Principal Investigator

Pennsylvania
Bethlehem

Lehigh Valley Hospital - Muhlenberg

Philip M. Monteleone
Ph: 484-884-2201

Philip M. Monteleone
Principal Investigator

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

Anne Fitzpatrick Reilly
Ph: 215-590-2810

Anne Fitzpatrick Reilly
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

Peter H. Shaw
Ph: 412-692-5573

Peter H. Shaw
Principal Investigator

Rhode Island
Providence

Rhode Island Hospital

Jennifer J. Greene Welch
Ph: 401-444-1488

Jennifer J. Greene Welch
Principal Investigator

South Carolina
Charleston

Medical University of South Carolina

Jacqueline M. Kraveka
Ph: 843-792-9321

Jacqueline M. Kraveka
Principal Investigator

Greenville

BI-LO Charities Children's Cancer Center

Nichole Leigh Bryant
Ph: 864-241-6251

Nichole Leigh Bryant
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
Chattanooga

T C Thompson Children's Hospital

Manoo G. Bhakta
Ph: 423-778-7289

Manoo G. Bhakta
Principal Investigator

Nashville

Vanderbilt University/Ingram Cancer Center

Debra L. Friedman
Ph: 800-811-8480

Debra L. Friedman
Principal Investigator

Texas
Austin

Dell Children's Medical Center of Central Texas

Amy Catherine Fowler
Ph: 214-648-7097

Amy Catherine Fowler
Principal Investigator

Corpus Christi

Driscoll Children's Hospital

M. Cris Johnson
Ph: 361-694-5311

M. Cris Johnson
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

Martha Marie Stegner
Ph: 214-648-7097

Martha Marie Stegner
Principal Investigator

Houston

Baylor College of Medicine

Carl E. Allen
Ph: 713-798-1354
Email: burton@bcm.edu

Carl E. Allen
Principal Investigator

Lubbock

Covenant Children's Hospital

Latha Prasannan
Ph: 806-725-8000
Email: jaccresearch@covhs.org

Latha Prasannan
Principal Investigator

San Antonio

Children's Hospital of San Antonio

Timothy C. Griffin
Ph: 713-798-1354
Email: burton@bcm.edu

Timothy C. Griffin
Principal Investigator

Methodist Children's Hospital of South Texas

Jaime Estrada
Ph: 210-575-7000

Jaime Estrada
Principal Investigator

Temple

Scott and White Memorial Hospital

Guy Howard Grayson
Ph: 254-724-5407

Guy Howard Grayson
Principal Investigator

Utah
Salt Lake City

Primary Children's Hospital

Phillip Evan Barnette
Ph: 801-585-5270

Phillip Evan Barnette
Principal Investigator

Virginia
Charlottesville

University of Virginia Cancer Center

Kimberly Panter Dunsmore
Ph: 434-243-6143

Kimberly Panter Dunsmore
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

Tacoma

Madigan Army Medical Center

Melissa Anne Forouhar
Ph: 253-968-0129
Email: mamcdci@amedd.army.mil

Melissa Anne Forouhar
Principal Investigator

Mary Bridge Children's Hospital and Health Center

Robert G. Irwin
Ph: 253-403-3229

Robert G. Irwin
Principal Investigator

Wisconsin
Green Bay

Saint Vincent Hospital

John Robert Hill
Ph: 920-433-8889

John Robert Hill
Principal Investigator

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

Hunter Regional Mail Centre

John Hunter Children's Hospital

Elizabeth Louise Hesketh
Ph: 888-823-5923
Email: ctsucontact@westat.com

Elizabeth Louise Hesketh
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

Christopher James Fraser
Ph: 888-823-5923
Email: ctsucontact@westat.com

Christopher James Fraser
Principal Investigator

Westmead

The Children's Hospital at Westmead

Geoffrey Brian McCowage
Ph: 61-2-9845 1400

Geoffrey Brian McCowage
Principal Investigator

Canada

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

Ontario
Hamilton

McMaster Children's Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100ext74595

Carol Portwine
Principal Investigator

Kingston

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Mariana Pradier Silva
Ph: 613-544-2630

Mariana Pradier Silva
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

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

Saskatchewan
Saskatoon

Saskatoon Cancer Centre

Christopher Mpofu
Ph: 306-655-2914

Christopher Mpofu
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01595048

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.