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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IISupportive care, TreatmentActive3 to 21NCI, OtherACNS1123
NCI-2012-01967, CDR0000734032, U10CA098543, 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 and Exclusion Criteria:

  • Patients must be newly diagnosed with localized primary CNS non germinomatous germ cell tumor (NGGCT) (Stratum 1) or localized primary CNS 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 with unifocal 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 CSF alpha-fetoprotein (AFP) > 10 ng/mL or greater than the institutional normal are eligible, irrespective of biopsy results
  • Patients with any of the following elements on biopsy/resection are eligible, irrespective of serum and/or CSF hCGβ and AFP levels: endodermal sinus tumor (yolk sac),embryonal carcinoma, choriocarcinoma, malignant/immature teratoma, and mixed GCT with 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 CSF are eligible; no histologic confirmation required
  • Patients with bifocal (pineal + suprasellar) involvement or pineal lesion with diabetes insipidus AND hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum and/or CSF are eligible; no histologic confirmation required
  • Patients with histologically confirmed germinoma or germinoma mixed with mature teratoma and hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum and/or CSF are eligible
  • Patients must have negative lumbar CSF cytology; lumbar CSF must be obtained unless medically contraindicated
  • Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123
  • Patients with mature teratoma with normal tumor markers are not eligible
  • Patients with tumors located outside the ventricles (basal ganglia, thalamus) are not eligible
  • Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are not eligible
  • Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL
  • Platelet count ≥ 100,000/μL (transfusion independent)
  • Hemoglobin ≥ 8.0 g/dL (may receive red blood cell [RBC] transfusions)
  • 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)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvate transaminase(SGPT) (alanine aminotransferase [ALT]) < 2.5 times ULN
  • Patients with seizure disorder may be enrolled if well controlled
  • Patients must not be in status, coma, or assisted ventilation prior to study enrollment
  • Female patients who are pregnant are ineligible
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
  • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
  • Patients who had more than 1 prior surgery/biopsy are eligible
  • Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids.

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

  • National Cancer Institute
Ute Bartels, MD, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

Children's Hospital of Alabama at University of Alabama at Birmingham

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

UAB Comprehensive Cancer Center

Alyssa T Reddy
Ph: 205-934-0309

Arizona
Phoenix

Phoenix Children's Hospital

Jessica Boklan
Ph: 602-546-0920

California
Downey

Southern California Permanente Medical Group

Robert M Cooper
Ph: 626-564-3455

Long Beach

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Theodore Zwerdling
Ph: 562-933-5600

Los Angeles

Children's Hospital Los Angeles

Leo Mascarenhas
Ph: 323-361-4110

Mattel Children's Hospital at UCLA

Tom B Davidson
Ph: 310-825-6708

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

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

Oakland

Children's Hospital and Research Center Oakland

Joseph C Torkildson
Ph: 510-450-7600

Orange

Children's Hospital of Orange County

Violet Shen
Ph: 714-997-3000

Palo Alto

Lucile Packard Children's Hospital at Stanford University Medical Center

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

Sacramento

Sutter Cancer Center

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

San Diego

Rady Children's Hospital - San Diego

William D Roberts
Ph: 858-966-5934

San Francisco

UCSF Helen Diller Family Comprehensive Cancer Center

Anuradha Banerjee
Ph: 877-827-3222

Torrance

Los Angeles Biomedical Research Institute

Joseph L Lasky
Ph: 888-662-8252

Colorado
Aurora

Children's Hospital Colorado Center for Cancer and Blood Disorders

Kathleen M Dorris
Ph: 720-777-6672

Connecticut
Hartford

Connecticut Children's Medical Center

Michael S Isakoff
Ph: 860-545-9981

New Haven

Yale Cancer Center

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

Delaware
Wilmington

Alfred I. duPont Hospital for Children

Andrew W Walter
Ph: 302-651-5755

District of Columbia
Washington

Children's National Medical Center

Jeffrey S Dome
Ph: 202-884-2549

Florida
Fort Myers

Children's Hospital of Southwest Florida

Emad K Salman
Ph: 239-343-5333

Gainesville

UF Health Cancer Center

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

Hollywood

Joe DiMaggio Children's Hospital

Iftikhar Hanif
Ph: 954-265-2234

Jacksonville

Nemours Children's Clinic

Andrew W Walter
Ph: 302-651-5755

Miami

Miami Children's Hospital

Enrique A Escalon
Ph: 305-662-8360

University of Miami Sylvester Comprehensive Cancer Center - Miami

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

Orlando

Arnold Palmer Hospital for Children

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

Florida Hospital Cancer Institute at Florida Hospital Orlando

Fouad M Hajjar
Ph: 407-303-5623

Nemours Children's Hospital

Andrew W Walter
Ph: 302-651-5755

Pensacola

Nemours Children's Clinic - Pensacola

Andrew W Walter
Ph: 302-651-5755

Saint Petersburg

All Children's Hospital

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

Tampa

Tampa General Hospital

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

West Palm Beach

Kaplan Cancer Center at St. Mary's Medical Center

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

Georgia
Atlanta

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

Glen Lew
Ph: 404-785-1112

Savannah

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

J. M Johnston
Ph: 912-350-8568

Hawaii
Honolulu

Kapiolani Medical Center for Women and Children

Robert W Wilkinson
Ph: 808-983-6090

Idaho
Boise

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Eugenia Chang
Ph: 800-845-4624

Illinois
Chicago

Ann and Robert H. Lurie Children's Hospital of Chicago

Stewart Goldman
Ph: 773-880-4562

University of Chicago Cancer Research Center

Susan L Cohn
Ph: 773-834-7424

University of Illinois Cancer Center

Mary L Schmidt
Ph: 312-355-3046

Maywood

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Eugene Suh
Ph: 708-226-4357

Oak Lawn

Keyser Family Cancer Center at Advocate Hope Children's Hospital

Rebecca E McFall
Ph: 847-723-7570

Peoria

Saint Jude Midwest Affiliate

Pedro A De Alarcon
Ph: 309-655-3258

Indiana
Indianapolis

Riley's Children Cancer Center at Riley Hospital for Children

Robert J Fallon
Ph: 888-823-5923
Email: ctsucontact@westat.com

St. Vincent Indianapolis Hospital

Bassem I Razzouk
Ph: 317-338-2194

Iowa
Des Moines

Blank Children's Hospital

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

Kentucky
Lexington

University of Kentucky Chandler Medical Center

Lars M Wagner
Ph: 859-257-3379

Louisville

Kosair Children's Hospital

Kenneth G Lucas
Ph: 866-530-5516

Louisiana
New Orleans

Children's Hospital of New Orleans

Lolie C Yu
Ph: 504-894-5377

Maryland
Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Massachusetts
Boston

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Carlos Rodriguez-Galindo
Ph: 866-790-4500

Massachusetts General Hospital

Howard J Weinstein
Ph: 877-726-5130

Michigan
Detroit

Wayne State University

Zhihong J Wang
Ph: 313-576-9363

Grand Rapids

Helen DeVos Children's Hospital at Spectrum Health

David S Dickens
Ph: 616-267-1925

Kalamazoo

Bronson Methodist Hospital

Katharina E Elliott
Ph: 800-227-2345

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

Bruce C Bostrom
Ph: 612-813-5193

Rochester

Mayo Clinic Cancer Center

Amulya A Nageswara Rao
Ph: 507-538-7623

Mississippi
Jackson

University of Mississippi Cancer Clinic

Gail C Megason
Ph: 601-815-6700

Missouri
Kansas City

Children's Mercy Hospital

Maxine L Hetherington
Ph: 816-234-3265

Saint Louis

David C. Pratt Cancer Center at St. John's Mercy

Bethany G. Sleckman
Ph: 913-948-5588

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

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

Nevada
Las Vegas

Cancer Institute of Nevada at Summerlin Hospital Medical Center

Jonathan Bernstein
Ph: 702-384-0013

CCOP - Nevada Cancer Research Foundation

Jonathan Bernstein
Ph: 702-384-0013

Children's Specialty Center of Nevada

Jonathan Bernstein
Ph: 702-384-0013

University Medical Center of Southern Nevada

Jonathan Bernstein
Ph: 702-384-0013

New Hampshire
Lebanon

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

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

New Jersey
Hackensack

Hackensack University Medical Center Cancer Center

Frances Flug
Ph: 201-996-2879

Morristown

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Steven L Halpern
Ph: 973-971-5900

New Brunswick

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Richard A Drachtman
Ph: 732-235-8675

Newark

Newark Beth Israel Medical Center

Peri Kamalakar
Ph: 973-926-7230

Summit

Overlook Hospital

Steven L Halpern
Ph: 973-971-5900

New Mexico
Albuquerque

University of New Mexico Cancer Center

Koh B Boayue
Ph: 505-272-6972

New York
Bronx

Montefiore Medical Center

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

Buffalo

Roswell Park Cancer Institute

Lorna K Fitzpatrick
Ph: 877-275-7724

Mineola

Winthrop University Hospital

Mark E Weinblatt
Ph: 866-946-8476

New Hyde Park

Schneider Children's Hospital

Mark P Atlas
Ph: 718-470-3470

New York

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Alice Lee
Ph: 212-305-8615

Memorial Sloan-Kettering Cancer Center

Peter G Steinherz
Ph: 212-639-7202

New York University Medical Center

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

Rochester

James P. Wilmot Cancer Center at University of Rochester Medical Center

Jeffrey R Andolina
Ph: 585-275-5830

Syracuse

SUNY Upstate Medical University Hospital

Karol H Kerr
Ph: 315-464-5476

Valhalla

New York Medical College

Jessica C Hochberg
Ph: 914-594-3794

North Carolina
Chapel Hill

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

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

Charlotte

Presbyterian Cancer Center at Presbyterian Hospital

Paulette C Bryant
Ph: 704-384-5369

Durham

Duke Cancer Institute

Susan G Kreissman
Ph: 888-275-3853

North Dakota
Fargo

Roger Maris Cancer Center at MeritCare Hospital

Samuel O Anim
Ph: 701-234-6161

Ohio
Akron

Akron Children's Hospital

Steven J Kuerbitz
Ph: 330-543-3193

Cincinnati

Cincinnati Children's Hospital Medical Center

John P Perentesis
Ph: 513-636-2799

Cleveland

Cleveland Clinic Taussig Cancer Center

Margaret C Thompson
Ph: 866-223-8100

Seidman Cancer Center at University Hospitals/Case Medical Center

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

Columbus

Nationwide Children's Hospital

Mark A Ranalli
Ph: 614-722-2708

Dayton

Dayton Children's - Dayton

Emmett H Broxson
Ph: 800-228-4055

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

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

Oregon
Portland

Knight Cancer Institute at Oregon Health and Science University

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

Legacy Emanuel Children's Hospital

Janice F Olson
Ph: 503-413-2560

Pennsylvania
Hershey

Penn State Children's Hospital

Lisa M McGregor
Ph: 717-531-6012

Philadelphia

Children's Hospital of Philadelphia

Michael J Fisher
Ph: 215-590-2810

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Regina I Jakacki
Ph: 412-692-5573

South Carolina
Columbia

Palmetto Health South Carolina Cancer Center

Ronnie W. Neuberg
Ph: 803-434-3680

Greenville

BI-LO Charities Children's Cancer Center

Nichole L Bryant
Ph: 864-241-6251

Cancer Centers of the Carolinas - Faris Road

Nichole L Bryant
Ph: 864-241-6251

South Dakota
Sioux Falls

Sanford Cancer Center at Sanford USD Medical Center

Kayelyn J Wagner
Ph: 605-328-1367

Tennessee
Knoxville

East Tennessee Children's Hospital

Ray C Pais
Ph: 865-541-8266

Memphis

St. Jude Children's Research Hospital

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

Nashville

Vanderbilt-Ingram Cancer Center

Adam Esbenshade
Ph: 800-811-8480

Texas
Corpus Christi

Driscoll Children's Hospital

M. C Johnson
Ph: 361-694-5311

Dallas

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Daniel C Bowers
Ph: 214-648-7097

Fort Worth

Cook Children's Medical Center - Fort Worth

Mary Meaghan P Granger
Ph: 682-885-2103

Houston

Dan L. Duncan Cancer Center at Baylor College of Medicine

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

Univeristy of Texas M.D. Anderson Cancer Center

Soumen Khatua
Ph: 713-792-3245

San Antonio

University of Texas Health Science Center at San Antonio

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

Utah
Salt Lake City

Primary Children's Medical Center

Phillip E Barnette
Ph: 801-585-5270

Virginia
Charlottesville

University of Virginia Cancer Center

Colleen H Druzgal
Ph: 434-243-6143

Falls Church

Inova Fairfax Hospital

Marshall A Schorin
Ph: 703-208-6650

Norfolk

Children's Hospital of The King's Daughters

Eric J Lowe
Ph: 757-668-7243

Richmond

Virginia Commonwealth University Massey Cancer Center

Asadullah Khan
Ph: 804-628-1939

Washington
Seattle

Children's Hospital and Regional Medical Center - Seattle

Douglas S Hawkins
Ph: 866-987-2000

Tacoma

Madigan Army Medical Center - Tacoma

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

Wisconsin
Madison

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Kenneth B DeSantes
Ph: 608-262-5223

Marshfield

Marshfield Clinic - Marshfield Center

Michael J McManus
Ph: 715-389-4457

Milwaukee

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Sachin S Jogal
Ph: 414-805-4380

Australia

New South Wales
Hunter Regional Mail Centre

John Hunter Hospital

Stewart J Kellie
Ph: 61-2-9845 1400

Randwick

Sydney Children's Hospital

Draga Barbaric
Ph: (02) 9382-1721

Westmead

Children's Hospital at Westmead

Geoffrey B McCowage
Ph: 61-2-9845 1400

Queensland
South Brisbane

Lady Cilento Children's Hospital

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

Victoria
Parkville

Royal Children's Hospital

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

Western Australia
Perth

Princess Margaret Hospital for Children

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

Canada

British Columbia
Vancouver

Children's and Women's Hospital of British Columbia

Caron Strahlendorf
Ph: 604-875-2345ext6477

Manitoba
Winnipeg

CancerCare Manitoba

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

Nova Scotia
Halifax

IWK Health Centre

Conrad V Fernandez
Ph: 902-470-8394

Ontario
Hamilton

McMaster Children's Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100ext74595

Toronto

Hospital for Sick Children

Ute K Bartels
Ph: 416-813-7654ext2027
Email: jason.mcguire@sickkids.ca

Quebec
Montreal

Hopital Sainte Justine

Yvan Samson
Ph: 514-345-4931

New Zealand

Christchurch

Christchurch Hospital

Siobhan F Cross
Ph: 03 364 0640

Auckland
Grafton

Starship Children's Health

Stephen J Laughton
Ph: 0800 728 436

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01602666
ClinicalTrials.gov processed this data on April 13, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.