Chemotherapy and Radiation Therapy in Treating Young Patients with Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, Treatment3 to 21ACNS0332
NCI-2009-00336, CDR0000511991, COG-ACNS0332, NCT00392327

Trial Description

Summary

This randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine whether carboplatin radiosensitization increases long term event-free survival for high risk medulloblastoma/primitive neuroectodermal tumor (PNET) patients.

II. To determine whether isotretinoin increases long term event-free survival for high risk medulloblastoma/PNET patients.

SECONDARY OBJECTIVES:

I. To compare residual disease response to radiation alone versus radiation plus carboplatin.

II. To identify molecular prognostic indicators suitable for patient stratification in future trials.

III. To evaluate the health-related quality of life (HRQOL) during phases of active treatment specific to treatment modalities.

IV. To describe the neuropsychological functioning of the study population and to evaluate the relationship between neuropsychological status and health related quality of life.

OUTLINE: Patients are randomized to Arm A or Arm B (Arms C and D closed to accrual as of Amendment 3 1/27/15).

ARM A (standard chemoradiotherapy and standard maintenance therapy):

CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily (QD) five days a week for 6 weeks. Patients also receive vincristine sulfate intravenously (IV) over 1 minute once weekly for 6 weeks. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive cisplatin IV over 6 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 8, and cyclophosphamide IV over 1 hour on days 2 and 3. Patients also receive filgrastim subcutaneously (SC) or IV beginning on day 4 and continuing until blood counts recover (at least 10 days). Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

ARM B (standard chemoradiotherapy plus carboplatin and standard maintenance therapy):

CHEMORADIOTHERAPY: Patients receive vincristine sulfate and undergo radiation therapy as in Arm I. Patients also receive carboplatin IV over 15 minutes on each day of radiation therapy. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm I.

ARM C (standard chemoradiotherapy, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin - CLOSED TO ACCRUAL 1/27/15):

CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm I. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive isotretinoin orally (PO) twice daily (BID) on day 1 and days 16-28 and cisplatin, vincristine sulfate, cyclophosphamide, and filgrastim as in Arm I maintenance therapy. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to continuation therapy.

CONTINUATION THERAPY: Patients receive isotretinoin PO BID on days 15-28 every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

ARM D (standard chemoradiotherapy plus carboplatin, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin - CLOSED TO ACCRUAL 1/27/15):

CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm II. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm III. Patients then proceed to continuation therapy.

CONTINUATION THERAPY: Patients receive continuation therapy as in Arm III.

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

Eligibility Criteria

Inclusion Criteria:

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:

0.8 mg/dL (2 to < 6 years of age)

1.0 mg/dL (6 to < 10 years of age)

1.2 mg/dL (10 to < 13 years of age)

1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)

1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)

All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

All patients and/or their parents or legal guardians must sign a written informed consent

Female patients who are post-menarchal must have a negative pregnancy test; lactating female patients must agree not to breast-feed while on this trial; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method

Hemoglobin >= 8 g/dl (may be transfused)

Platelets >= 100,000/uL (untransfused)

Absolute neutrophil count (ANC) >= 1,000/uL

Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age; for patients on anti-seizure medications, SGOT (AST) or SGPT (ALT) must be < 5 x ULN

Total bilirubin < 1.5 x upper limit of normal (ULN) for age

No other experimental therapy is permitted while on study

Cisplatin should be used with caution with nephrotoxic drug; aminoglycoside should be avoided or used with caution during or shortly after cisplatin administration and concomitant use with amphotericin B should probably also be avoided; patients receiving cisplatin and other potentially ototoxic drugs such as aminoglycoside or loop diuretics concomitantly should be closely monitored for signs of ototoxicity

Plasma levels of anticonvulsant agents should be monitored and doses adjusted during therapy with cisplatin

Patients must have a Karnofsky performance level of >= 30 for patients > 16 years of age or a Lansky performance scale of >= 30 for patients =< 16 years of age and life expectancy > 8 weeks

CYP450 3A4 stimulators or inhibitors should be avoided or used with great caution when taking cyclophosphamide; aprepitant should also be used with caution with etoposide or vincristine chemotherapy

Corticosteroids should not be used during chemotherapy administration as an antiemetic

No previous chemotherapy or radiation therapy

Lumbar cerebrospinal fluid (CSF) cytology examination must be obtained pre-operatively or within 31 days following surgery; the optimal time for obtaining CSF is prior to surgery or 1-3 weeks following surgery; ventricular CSF (either pre- or post-op) may be used only if a post-operative spinal tap is contraindicated; if a spinal tap is contraindicated and there is no ventricular CSF available, then CSF cytology can be waived for patients with supratentorial tumors or if there is documentation of spinal subarachnoid metastases (M3); patients who are categorized as M1 must have either an intra-operative positive CSF (via lumbar puncture at the end of the procedure) or a positive lumbar CSF obtained > 7 days post-operatively

A pre-operative magnetic resonance imaging (MRI) scan of the brain with and without contrast is required; NOTE: computed tomography (CT) scans are NOT sufficient for study eligibility

Post-operative head MRI scan with and without contrast (preferably within 72 hours post-surgery); for patients who undergo stereotactic biopsy only, either a pre or post-operative MRI is sufficient; for patients with M2 and M3 disease, a post-op MRI is strongly encouraged, but not mandatory

Spinal MRI imaging with and without gadolinium is required within 10 days of surgery if done pre-operatively or within 28 days of surgery if done post-operatively; for posterior fossa tumors, pre-operative MRI scans are preferred

Newly diagnosed, previously untreated: (1) M0 medulloblastoma with > 1.5 cm^2 residual; (2) M+ medulloblastoma; patients with diffusely anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor

As of amendment # 2, enrollment of patients with supratentorial PNET has been discontinued

All patients with M4 disease are not eligible

Selected strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (cytochrome P450 3A4) include azole antifungals, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and St. John’s wort; the use of these drugs should be avoided with vincristine (vincristine sulfate)

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Children's Oncology Group

  • National Cancer Institute
James Michael Olson, 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

Arkansas
Little Rock

Arkansas Children's Hospital

David L. Becton
Ph: 501-364-7373

David L. Becton
Principal Investigator

California
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

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

Joseph Charles Torkildson
Ph: 510-450-7600

Joseph Charles Torkildson
Principal Investigator

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

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

Jay Michael S. Balagtas
Principal Investigator

San Francisco

UCSF Medical Center-Mission Bay

Anuradha Banerjee
Ph: 877-827-3222

Anuradha Banerjee
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

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

Andrew William Walter
Ph: 302-651-5755

Andrew William Walter
Principal Investigator

District of Columbia
Washington

Children's National Medical Center

Jeffrey Stuart Dome
Ph: 202-884-2549

Jeffrey Stuart Dome
Principal Investigator

Florida
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

Andrew William Walter
Ph: 302-651-5755

Andrew William Walter
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: 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

Andrew William Walter
Ph: 302-651-5755

Andrew William Walter
Principal Investigator

Pensacola

Nemours Children's Clinic - Pensacola

Andrew William Walter
Ph: 302-651-5755

Andrew William Walter
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

Mark J. Mogul
Ph: 800-882-4123

Mark J. Mogul
Principal Investigator

Tampa General Hospital

Cameron K. Tebbi
Ph: 800-882-4123
Email: hkourtellis@tgh.org

Cameron K. Tebbi
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

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

Stewart Goldman
Ph: 773-880-4562

Stewart Goldman
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

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

Park Ridge

Advocate Children's Hospital-Park Ridge

Jong-Hyo Kwon
Ph: 847-384-3621

Jong-Hyo Kwon
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

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
Bangor

Eastern Maine Medical Center

Sam Wei Lew
Ph: 207-973-4274

Sam Wei Lew
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

Massachusetts
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

Patricia L. Robertson
Ph: 800-865-1125

Patricia L. Robertson
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

Kanta Bhambhani
Ph: 313-576-9363

Kanta Bhambhani
Principal Investigator

East Lansing

Michigan State University Clinical Center

Renuka Gera
Ph: 517-975-9547

Renuka Gera
Principal Investigator

Kalamazoo

Bronson Methodist Hospital

Jeffrey S. Lobel
Ph: 800-227-2345

Jeffrey S. Lobel
Principal Investigator

Kalamazoo Center for Medical Studies

Jeffrey S. Lobel
Ph: 800-227-2345

Jeffrey S. Lobel
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

Amulya Anakapalli Nageswara Rao
Ph: 507-538-7623

Amulya Anakapalli Nageswara Rao
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

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

Joshua B. Rubin
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Joshua B. Rubin
Principal Investigator

Nebraska
Omaha

Children's Hospital and Medical Center of Omaha

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

Summerlin Hospital Medical Center

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Sunrise Hospital and Medical Center

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

Derek R. Hanson
Ph: 201-996-2879

Derek R. Hanson
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

Paterson

Saint Joseph's Regional Medical Center

Mary Ann Bonilla
Ph: 973-754-2909

Mary Ann Bonilla
Principal Investigator

Summit

Overlook Hospital

Steven Lon Halpern
Ph: 973-971-5900

Steven Lon Halpern
Principal Investigator

New Mexico
Albuquerque

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

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

Mark P. Atlas
Ph: 718-470-3470

Mark P. Atlas
Principal Investigator

New York

Columbia University Medical Center

Alice Lee
Ph: 212-305-8615

Alice Lee
Principal Investigator

Memorial Sloan-Kettering Cancer Center

Peter Gustav Steinherz
Ph: 212-639-7202

Peter Gustav Steinherz
Principal Investigator

Mount Sinai Medical Center

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

Birte Wistinghausen
Principal Investigator

Rochester

University of Rochester

Jeffrey Robert Andolina
Ph: 585-275-5830

Jeffrey Robert Andolina
Principal Investigator

Stony Brook

Stony Brook University Medical Center

Robert Ingalls Parker
Ph: 800-862-2215

Robert Ingalls Parker
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
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

Winston-Salem

Wake Forest University Health Sciences

Sharon M. Castellino
Ph: 336-713-6771

Sharon M. Castellino
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

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

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

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

Michael J. Fisher
Ph: 215-590-2810

Michael J. Fisher
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

Regina Irene Jakacki
Ph: 412-692-5573

Regina Irene Jakacki
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

Greenville Cancer Treatment 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

Devang J Pastakia
Ph: 800-811-8480

Devang J Pastakia
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

Daniel Charles Bowers
Ph: 214-648-7097

Daniel Charles Bowers
Principal Investigator

Fort Worth

Cook Children's Medical Center

Jeffrey Carlton Murray
Ph: 682-885-2103

Jeffrey Carlton Murray
Principal Investigator

Houston

Baylor College of Medicine

Murali Mohan Chintagumpala
Ph: 713-798-1354
Email: burton@bcm.edu

Murali Mohan Chintagumpala
Principal Investigator

Lubbock

Covenant Children's Hospital

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

Latha Prasannan
Principal Investigator

San Antonio

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

Vermont
Burlington

University of Vermont College of Medicine

Alan Charles Homans
Ph: 802-656-4101

Alan Charles Homans
Principal Investigator

Virginia
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

Richmond

Virginia Commonwealth University/Massey Cancer Center

Asadullah Khan
Ph: 804-628-1939

Asadullah Khan
Principal Investigator

Roanoke

Carilion Clinic Children's Hospital

Mandy Meck Atkinson
Ph: 540-981-7376

Mandy Meck Atkinson
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

West Virginia
Charleston

West Virginia University Charleston

Chibuzo C. O'Suoji
Ph: 304-388-9944

Chibuzo C. O'Suoji
Principal Investigator

Morgantown

West Virginia University Healthcare

Stephan R. Paul
Ph: 304-293-2745
Email: sfilburn@hsc.wvu.edu

Stephan R. Paul
Principal Investigator

Wisconsin
Green Bay

Saint Vincent Hospital

John Robert Hill
Ph: 920-433-8889

John Robert Hill
Principal Investigator

Marshfield

Marshfield Clinic

Michael John McManus
Ph: 715-389-4457

Michael John McManus
Principal Investigator

Milwaukee

Midwest Children's Cancer Center

Sachin S. Jogal
Ph: 414-805-4380

Sachin S. Jogal
Principal Investigator

Australia

North Adelaide

Women's and Children's Hospital-Adelaide

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

Maria Louise Kirby
Principal Investigator

Canada

Alberta
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

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

Toronto

Hospital for Sick Children

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

Sarah Weeks Alexander
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 NCT00392327

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.