Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors

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

Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IISupportive care, Treatment3 to 21ACNS1123
NCI-2012-01967, CDR0000734032, COG-ACNS1123, NCT01602666

Trial Description

Summary

Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy with radiation therapy may kill more tumor cells. This phase II trial studies how well chemotherapy and radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine, as measured by the 3-year progression-free survival (PFS) rate and patterns of failure, whether dose and volume of irradiation can be safely reduced to 30.6 Gy whole ventricular-field irradiation (WVI) plus 23.4 Gy primary site boost instead of 36 Gy craniospinal irradiation (CSI) plus primary site boost in the subgroup of children and young adults with localized nongerminomatous germ cell tumor (NGGCT) who have a magnetic resonance imaging (MRI) and tumor marker criteria (CSF and serum) for confirmed complete response (CR) or partial response (PR) to induction chemotherapy and negative serum and cerebrospinal fluid (CSF) tumor markers OR in patients who have less than a PR after induction chemotherapy with negative tumor markers who undergo a second-look surgery and are found to have only mature teratoma, residual scar or fibrosis, and fit the definition of CR/PR after second-look surgery.

II. To determine, as measured by the 3-year PFS rate and patterns of failure, whether simplified chemotherapy followed by dose-reduced radiation therapy is effective for treating children and young

adults with localized primary central nervous system (CNS) germinoma who present with serum and/or CSF human chorionic gonadotropin-beta (hCGβ) =< 50 mIU/mL.

III. To prospectively evaluate and longitudinally model the cognitive, social, and behavioral functioning of

children and young adults who are treated with reduced radiation dose and volume of irradiation in

Stratum 1 (NGGCT) and with dose-reduced radiation therapy in Stratum 2 (Germinoma) using the ALTE07C1 protocol (This objective will be assessed independently for the two strata).

SECONDARY OBJECTIVES:

To estimate the PFS and overall survival (OS) distributions of patients with NGGCT treated with 30.6 Gy

WVI and involved-field radiation therapy (IFR) focal boost to 54 Gy.

II. To estimate the PFS and OS distributions of localized-germinoma patients who present with serum and/or CSF hCGβ ≤ 50 mIU/mL vs serum and/or CSF hCGβ > 50 mIU/mL and =< 100 mIU/mL.

OUTLINE: This is a multicenter study. Patients are stratified according to localized primary disease (nongerminomatous germ cell tumor [NGGCT] vs germinoma).

Stratum 1 (NGGCT): Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 1-2 hours on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 1 hour and etoposide over 1-2 hours on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive disease (complete [CR] or partial response [PR]) to induction chemotherapy undergo radiotherapy once daily (QD) 5 days a week for 6 weeks. Patients with PR, stable disease (SD), or progressive disease (PD) and normalization of tumor levels undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo radiotherapy.

Stratum 2 (Germinoma): Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR undergo radiotherapy QD 5 days a week for approximately 4 weeks. Patients with PR, SD, or PD with normal tumor markers may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor during surgery undergo radiotherapy. Patients with PR or SD with residual disease (=< 1.5 cm) and suprasellar (> 0.5 cm) or pineal (> 1 cm) involvement and normal tumor markers undergo radiotherapy after chemotherapy without second-look surgery.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, and then annually for up to 3 years.

Eligibility Criteria

Inclusion Criteria:

Lactating females are not eligible unless they have agreed not to breastfeed their infants

Patients who had more than 1 prior surgery/biopsy are eligible

Sexually active patients of reproductive potential are not eligible unless they have agreed to use aneffective contraceptive method for the duration of their study participation

Female patients of childbearing potential are not eligible unless a negative pregnancy test result has beenobtained

Female patients who are pregnant are ineligible

Patients must not be in status, coma, or assisted ventilation prior to study enrollment

Patients with seizure disorder may be enrolled if well controlled

Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvate transaminase(SGPT) (alanine aminotransferase [ALT]) < 2.5 times ULN

Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m² OR serum creatinine based on age/gender as follows:

0.4 mg/dL ( 1 month to < 6 months of age)

0.5 mg/dL (6 months to < 1 year of age)

0.6 mg/dL (1 to < 2 years of age)

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) and 1.4 mg/dL (female) (13 to < 16 years of age)

1.7 mg/dL (male) and 1.4 mg/dL (female) (≥ 16 years of age)

Hemoglobin ≥ 8.0 g/dL (may receive red blood cell [RBC] transfusions)

Platelet count ≥ 100,000/μL (transfusion independent)

Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL

Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are not eligible

Patients with tumors located outside the ventricles (basal ganglia, thalamus) are not eligible

Patients with mature teratoma with normal tumor markers are not eligible

Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123

Patients must have negative lumbar CSF cytology; lumbar CSF must be obtained unless medicallycontraindicated

Patients must be newly diagnosed with localized primary CNS nongerminomatousgerm cell tumor (NGGCT) (Stratum 1) or localized primaryCNS germinoma (Stratum 2); germ cell tumors (GCTs) located in the suprasellar, pineal, bifocal (pineal +suprasellar), and ventricles are eligible; tumors present in the above mentioned locations and withunifocal parenchymal extension are eligible

Stratum 1( NGGCT): Patients must have one of the following criteria:

  • Patients with serum and/or CSF hCGβ > 100 mIU/mL or any elevation of serum and CSFalpha-fetoprotein (AFP) > 10 ng/mL or greater than the institutional normal are eligible, irrespective ofbiopsy results
  • Patients with any of the following elements on biopsy/resection are eligible, irrespectiveof serum and/or CSF hCGβ and AFP levels: endodermal sinus tumor (yolk sac),embryonal carcinoma, choriocarcinoma, malignant/immature teratoma, and mixed GCTwith malignant GCT elements

Stratum 2 (Germinoma): Patients must have one of the following criteria:

  • Patients with institutional normal AFP AND hCGβ 5 to ≤ 50 mIU/mL in serum and/or CSFare eligible; no histologic confirmation required
  • Patients with bifocal (pineal + suprasellar) involvement or pineal lesion with diabetesinsipidus AND hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum and/or CSFare eligible; no histologic confirmation required
  • Patients with histologically confirmed germinoma or germinoma mixed with matureteratoma and hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum and/or CSF areeligible

Patients must not have received any prior tumor-directed therapy other than surgical intervention andcorticosteroids

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Children's Oncology Group

  • National Cancer Institute
Ute Katharina Bartels, 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

University of Alabama at Birmingham Cancer Center

Alyssa Terry Reddy
Ph: 205-934-0309

Alyssa Terry Reddy
Principal Investigator

Arizona
Phoenix

Phoenix Childrens Hospital

Jessica Boklan
Ph: 602-546-0920

Jessica Boklan
Principal Investigator

California
Downey

Southern California Permanente Medical Group

Robert Michael Cooper
Ph: 626-564-3455

Robert Michael Cooper
Principal Investigator

Long Beach

Miller Children's and Women's Hospital Long Beach

Theodore Zwerdling
Ph: 562-933-5600

Theodore Zwerdling
Principal Investigator

Los Angeles

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

Mattel Children's Hospital UCLA

Tom Belle Davidson
Ph: 310-825-6708

Tom Belle Davidson
Principal Investigator

Oakland

Children's Hospital and Research Center at Oakland

Joseph Charles Torkildson
Ph: 510-450-7600

Joseph Charles Torkildson
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

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

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

Colorado
Aurora

Children's Hospital Colorado

Kathleen M. O'Toole Dorris
Ph: 720-777-6672

Kathleen M. O'Toole Dorris
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

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

Andrew William Walter
Ph: 302-651-5755

Andrew William Walter
Principal Investigator

Miami

Miami Children's Hospital

Enrique Alberto Escalon
Ph: 305-662-8360

Enrique Alberto Escalon
Principal Investigator

University of Miami Miller School of Medicine-Sylvester Cancer Center

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

Julio Cesar Barredo
Principal Investigator

Orlando

Arnold Palmer Hospital for Children

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

Vincent Ferdinando Giusti
Principal Investigator

Florida Hospital Orlando

Fouad M. Hajjar
Ph: 407-303-5623

Fouad M. Hajjar
Principal Investigator

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

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

Peoria

Saint Jude Midwest Affiliate

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

Pedro A. De Alarcon
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

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

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
Boston

Dana-Farber Cancer Institute

Carlos Rodriguez-Galindo
Ph: 877-442-3324

Carlos Rodriguez-Galindo
Principal Investigator

Massachusetts General Hospital Cancer Center

Howard Jeffrey Weinstein
Ph: 877-726-5130

Howard Jeffrey Weinstein
Principal Investigator

Michigan
Detroit

Wayne State University/Karmanos Cancer Institute

Zhihong Joanne Wang
Ph: 313-576-9363

Zhihong Joanne Wang
Principal Investigator

Grand Rapids

Helen DeVos Children's Hospital at Spectrum Health

David Scott Dickens
Ph: 616-267-1925

David Scott Dickens
Principal Investigator

Kalamazoo

Bronson Methodist Hospital

Katharina Elisabeth Elliott
Ph: 800-227-2345

Katharina Elisabeth Elliott
Principal Investigator

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

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

Karen M. Gauvain
Ph: 314-268-4000
Email: info@siteman.wustl.edu

Karen M. Gauvain
Principal Investigator

Nevada
Las Vegas

Children's Specialty Center of Nevada II

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Nevada Cancer Research Foundation CCOP

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Summerlin Hospital Medical Center

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

University Medical Center of Southern Nevada

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

New Hampshire
Lebanon

Dartmouth Hitchcock Medical Center

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

Sara Chaffee
Principal Investigator

New Jersey
Hackensack

Hackensack University Medical Center

Frances Flug
Ph: 201-996-2879

Frances Flug
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

Peri Kamalakar
Ph: 973-926-7230

Peri Kamalakar
Principal Investigator

Summit

Overlook Hospital

Steven Lon Halpern
Ph: 973-971-5900

Steven Lon Halpern
Principal Investigator

New Mexico
Albuquerque

University of New Mexico Cancer Center

Koh B. Boayue
Ph: 505-272-6972

Koh B. Boayue
Principal Investigator

New York
Bronx

Montefiore Medical Center - Moses Campus

Rosanna J. Ricafort
Ph: 718-904-2730
Email: aecc@aecom.yu.edu

Rosanna J. Ricafort
Principal Investigator

Buffalo

Roswell Park Cancer Institute

Lorna K. Fitzpatrick
Ph: 877-275-7724

Lorna K. Fitzpatrick
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

Laura and Issac Perlmutter Cancer Center at NYU Langone

Jeffrey C. Allen
Ph: 212-263-4434
Email: prmc.coordinator@nyumc.org

Jeffrey C. Allen
Principal Investigator

Memorial Sloan-Kettering Cancer Center

Peter Gustav Steinherz
Ph: 212-639-7202

Peter Gustav Steinherz
Principal Investigator

Rochester

University of Rochester

Jeffrey Robert Andolina
Ph: 585-275-5830

Jeffrey Robert Andolina
Principal Investigator

Syracuse

State University of New York Upstate Medical University

Karol Hicks Kerr
Ph: 315-464-5476

Karol Hicks Kerr
Principal Investigator

Valhalla

New York Medical College

Jessica Cassara Hochberg
Ph: 914-594-3794

Jessica Cassara Hochberg
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

Novant Health Presbyterian Medical Center

Paulette Charese Bryant
Ph: 704-384-5369

Paulette Charese Bryant
Principal Investigator

Durham

Duke University Medical Center

Susan G. Kreissman
Ph: 888-275-3853

Susan G. Kreissman
Principal Investigator

North Dakota
Fargo

Sanford Medical Center-Fargo

Samuel Odame Anim
Ph: 701-234-6161

Samuel Odame Anim
Principal Investigator

Ohio
Akron

Children's Hospital Medical Center of Akron

Steven J. Kuerbitz
Ph: 330-543-3193

Steven J. Kuerbitz
Principal Investigator

Cincinnati

Cincinnati Children's Hospital Medical Center

John Peter Perentesis
Ph: 513-636-2799

John Peter Perentesis
Principal Investigator

Cleveland

Cleveland Clinic Foundation

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

Kellie Jean Nazemi
Ph: 503-494-1080
Email: trials@ohsu.edu

Kellie Jean Nazemi
Principal Investigator

Pennsylvania
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

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Regina Irene Jakacki
Ph: 412-692-5573

Regina Irene Jakacki
Principal Investigator

South Carolina
Columbia

Palmetto Health Richland

Ronnie W. Neuberg
Ph: 803-434-3680

Ronnie W. Neuberg
Principal Investigator

Greenville

BI-LO Charities Children's Cancer Center

Nichole Leigh Bryant
Ph: 864-241-6251

Nichole Leigh Bryant
Principal Investigator

Greenville Cancer Treatment Center

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
Knoxville

East Tennessee Childrens Hospital

Ray C. Pais
Ph: 865-541-8266

Ray C. Pais
Principal Investigator

Memphis

St. Jude Children's Research Hospital

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

Wayne Lee Furman
Principal Investigator

Nashville

Vanderbilt University/Ingram Cancer Center

Adam Esbenshade
Ph: 800-811-8480

Adam Esbenshade
Principal Investigator

Texas
Corpus Christi

Driscoll Children's Hospital

M. Cris Johnson
Ph: 361-694-5311

M. Cris Johnson
Principal Investigator

Dallas

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

Mary Meaghan Petty Granger
Ph: 682-885-2103

Mary Meaghan Petty Granger
Principal Investigator

Houston

Baylor College of Medicine

Jack Meng-Fen Su
Ph: 713-798-1354
Email: burton@bcm.edu

Jack Meng-Fen Su
Principal Investigator

M D Anderson Cancer Center

Soumen Khatua
Ph: 713-792-3245

Soumen Khatua
Principal Investigator

San Antonio

University of Texas Health Science Center at San Antonio

Anne-Marie R. Langevin
Ph: 210-450-3800
Email: CTO@uthscsa.edu

Anne-Marie R. Langevin
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

Colleen Harkins Druzgal
Ph: 434-243-6143

Colleen Harkins Druzgal
Principal Investigator

Falls Church

Inova Fairfax Hospital

Marshall A. Schorin
Ph: 703-208-6650

Marshall A. Schorin
Principal Investigator

Norfolk

Childrens Hospital-King's Daughters

Eric Jeffrey Lowe
Ph: 757-668-7243

Eric Jeffrey Lowe
Principal Investigator

Richmond

Virginia Commonwealth University/Massey Cancer Center

Asadullah Khan
Ph: 804-628-1939

Asadullah Khan
Principal Investigator

Washington
Seattle

Seattle Children's Hospital

Douglas S. Hawkins
Ph: 866-987-2000

Douglas S. Hawkins
Principal Investigator

Tacoma

Madigan Army Medical Center

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

Melissa Anne Forouhar
Principal Investigator

Wisconsin
Madison

University of Wisconsin Hospital and Clinics

Kenneth Brian DeSantes
Ph: 608-262-5223

Kenneth Brian DeSantes
Principal Investigator

Marshfield

Marshfield Clinic

Michael John McManus
Ph: 715-389-4457

Michael John McManus
Principal Investigator

Milwaukee

Midwest Children's Cancer Center

Sachin S. Jogal
Ph: 414-805-4380

Sachin S. Jogal
Principal Investigator

Australia

Hunter Regional Mail Centre

John Hunter Children's Hospital

Stewart John Kellie
Ph: 61-2-9845 1400

Stewart John Kellie
Principal Investigator

Parkville

Royal Children's Hospital

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

Francoise Marie Mechinaud
Principal Investigator

Perth

Princess Margaret Hospital for Children

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

Catherine Helen Cole
Principal Investigator

Randwick

Sydney Children's Hospital

Draga Barbaric
Ph: (02) 9382-1721

Draga Barbaric
Principal Investigator

South Brisbane

Lady Cilento Children's Hospital

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

Helen Irving
Principal Investigator

Westmead

The Children's Hospital at Westmead

Geoffrey Brian McCowage
Ph: 61-2-9845 1400

Geoffrey Brian McCowage
Principal Investigator

Canada

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

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

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

New Zealand

Christchurch

Christchurch Hospital

Siobhan Frances Cross
Ph: 03 364 0640

Siobhan Frances Cross
Principal Investigator

Grafton

Starship Children's Hospital

Stephen John Laughton
Ph: 0800 728 436

Stephen John Laughton
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01602666

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.