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Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive3 to 21NCI, OtherACNS0332
NCI-2009-00336, COG-ACNS0332, CDR0000511991, U10CA098543, R01CA114567, NCT00392327

Trial Description

Summary

This randomized phase III trial is studying different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma or supratentorial primitive neuroectodermal tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Isotretinoin may help chemotherapy work better by making tumor cells more sensitive to the drugs. 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. Determine whether carboplatin radiosensitization increases long-term, event-free survival of pediatric patients with newly diagnosed, previously untreated, high-risk medulloblastoma or supratentorial primitive neuroectodermal tumors.

II. Determine whether isotretinoin increases long-term, event-free survival of these patients.

SECONDARY OBJECTIVES:

I. Compare residual disease response to radiotherapy alone versus radiotherapy and carboplatin in these patients.

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

OUTLINE: This is a randomized, open-label, factorial-designed, multicenter study. Patients are stratified according to location of disease and dissemination status (M0 medulloblastoma with > 1.5 cm² residual tumor vs M+ medulloblastoma vs M0 supratentorial primitive neuroectodermal tumor [SPNET] with < 1.5 cm² residual tumor vs M0 SPNET with > 1.5 cm² residual tumor vs M+ SPNET vs M0 diffusely anaplastic medulloblastoma). Patients are randomized to 1 of 4 treatment arms.

ARM I (standard chemoradiotherapy and standard maintenance therapy):

CHEMOTHERAPY: Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40 and receive vincristine IV over 1 minute on days 1, 8, 15, 22, 29, and 36. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive cisplatin IV over 6 hours on day 1, vincristine IV over 1 minute on days 1 and 8, and cyclophosphamide IV over 1 hour on days 2 and 3. Patients also receive filgrastim (G-CSF) 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 II (standard chemoradiotherapy plus carboplatin and standard maintenance therapy):

CHEMORADIOTHERAPY: Patients receive carboplatin IV over 15 minutes once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40 and undergo radiotherapy and receive vincristine as in arm I. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

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

ARM III (standard chemoradiotherapy, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin):

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

MAINTENANCE THERAPY: Patients receive oral isotretinoin twice daily on day 1 and days 16-28 and cisplatin, vincristine, cyclophosphamide, and G-CSF 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 oral isotretinoin twice daily on days 15-28.

Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

ARM IV (standard chemoradiotherapy plus carboplatin, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin):

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:

  • Histologically confirmed diagnosis of medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET)
  • Newly diagnosed disease
  • Previously untreated disease
  • Meets 1 of the following criteria:
  • M0 medulloblastoma with > 1.5 cm² residual tumor
  • M+ medulloblastoma
  • M0 or M+ supratentorial PNET (including pineoblastoma)
  • Diffusely anaplastic medulloblastoma with any M-stage or residual tumor
  • Must have undergone stereotactic biopsy or attempted neurosurgical resection of the tumor within the past 31 days
  • The following procedures are required:
  • Pre-operative MRI of the brain with and without contrast
  • Post-operative (preferably within 72 hours after surgery) MRI of the brain with and without contrast**
  • Spinal MRI with and without contrast within 10 days before surgery or 28 days after surgery
  • Lumbar cerebrospinal fluid (CSF) cytological examination obtained pre-operatively or within 31 days after surgery***
  • No M4 disease
  • Karnofsky performance status (PS) 30-100% (for patients > 16 years of age) OR Lansky PS 30-100% (for patients ≤ 16 years of age)
  • Life expectancy > 8 weeks
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 effective forms of contraception
  • Creatinine normal OR creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age and/or 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) 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)
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST and ALT < 2.5 times ULN (5 times ULN for patients on antiseizure medications)
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³ (transfusions not allowed)
  • Hemoglobin ≥ 8 g/dL (transfusions allowed)
  • No concurrent corticosteroids as an antiemetic during chemotherapy
  • No prior chemotherapy or radiotherapy
  • No other concurrent experimental therapy
  • No concurrent isotretinoin for acne treatment

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

National Cancer Institute

James OlsonPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 Children's Hospital of Alabama at University of Alabama at Birmingham
 Alyssa T Reddy Ph: 205-934-0309
 UAB Comprehensive Cancer Center
 Alyssa T Reddy Ph: 205-934-0309
Arkansas
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 David L Becton Ph: 501-364-7373
California
  Arcadia
 Children's Oncology Group
 James M Olson Ph: 206-667-7955
  Email: jolson@fhcrc.org
  Loma Linda
 Loma Linda University Cancer Institute at Loma Linda University Medical Center
 Antranik A Bedros Ph: 909-558-3375
  Long Beach
 Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
 Shadi Farzin-Gohar Ph: 909-558-3375
  Los Angeles
 Childrens Hospital Los Angeles
 Leo Mascarenhas Ph: 323-361-4110
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Carole H Hurvitz Ph: 310-423-8965
  Madera
 Children's Hospital Central California
 Vonda L Crouse Ph: 866-353-5437
  Oakland
 Children's Hospital and Research Center Oakland
 Joseph C Torkildson Ph: 510-450-7600
 Kaiser Permanente-Oakland
 Vincent A Kiley Ph: 626-564-3455
  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
 University of California Davis Cancer Center
 Jay Michael S Balagtas Ph: 916-734-3089
  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
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
 Christopher N Frantz Ph: 302-651-5755
District of Columbia
  Washington
 Children's National Medical Center
 Jeffrey S Dome Ph: 202-884-2549
Florida
  Fort Myers
 Lee Cancer Care of Lee Memorial Health System
 Emad K Salman Ph: 239-343-5333
  Hollywood
 Joe DiMaggio Children's Hospital
 Iftikhar Hanif Ph: 954-265-2234
  Jacksonville
 Nemours Children's Clinic
 Eric S Sandler Ph: 904-697-3529
  Miami
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 Julio C Barredo Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Clifford A Selsky Ph: 407-303-5623
 M.D. Anderson Cancer Center at Orlando
 Vincent F Giusti Ph: 321-841-7246
 Nemours Children's Clinic - Orlando
 Ramamoorthy Nagasubramanian Ph: 407-650-7150
  Pensacola
 Nemours Children's Clinic - Pensacola
 Jeffrey H Schwartz Ph: 904-697-3529
  Saint Petersburg
 All Children's Hospital
 Gregory A Hale Ph: 727-767-2423
  Email: HamblinF@allkids.org
  Tampa
 St. Joseph's Children's Hospital of Tampa
 Hardeo K Panchoosingh Ph: 800-882-4123
  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
 Howard M Katzenstein Ph: 888-785-1112
  Savannah
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 J. Martin Johnston Ph: 912-350-8568
Hawaii
  Honolulu
 Cancer Research Center of Hawaii
 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
 David O Walterhouse 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
 Ricarchito B Manera Ph: 708-226-4357
  Oak Lawn
 Keyser Family Cancer Center at Advocate Hope Children's Hospital
 Sharad N Salvi Ph: 847-723-7570
  Park Ridge
 Advocate Lutheran General Cancer Care Center
 Jong H Kwon Ph: 847-384-3621
  Peoria
 Saint Jude Midwest Affiliate
 Pedro A De Alarcon Ph: 309-655-3258
  Springfield
 Simmons Cooper Cancer Institute
 Gregory P Brandt Ph: 217-545-7929
Indiana
  Indianapolis
 Riley's Children Cancer Center at Riley Hospital for Children
 Robert J Fallon Ph: 317-274-2552
 St. Vincent Indianapolis Hospital
 Bassem I Razzouk Ph: 317-338-2194
Iowa
  Des Moines
 Blank Children's Hospital
 Wendy L Woods-Swafford Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Ayman A El-Sheikh Ph: 800-237-1225
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 Martha F Greenwood Ph: 859-257-3379
  Louisville
 Kosair Children's Hospital
 Salvatore J Bertolone Ph: 866-530-5516
Louisiana
  New Orleans
 Children's Hospital of New Orleans
 Lolie C Yu Ph: 504-894-5377
 Tulane Cancer Center at Tulane University Hospital and Clinic
 Tammuella C Singleton Ph: 504-988-6121
Maryland
  Baltimore
 Greenebaum Cancer Center at University of Maryland Medical Center
 Teresa A York Ph: 800-888-8823
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Kenneth J Cohen Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
  Bethesda
 National Naval Medical Center
 Anne B Warwick Ph: 301-319-2100
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Carlos Rodriguez-Galindo Ph: 866-790-4500
 Floating Hospital for Children at Tufts - New England Medical Center
 Johannes E Wolff Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
 Massachusetts General Hospital
 Howard J Weinstein Ph: 877-726-5130
Michigan
  Ann Arbor
 C.S. Mott Children's Hospital at University of Michigan Medical Center
 Patricia L Robertson Ph: 800-865-1125
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Hadi Sawaf Ph: 313-343-3166
 Wayne State University
 Kanta Bhambhani 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
 Jeffrey S Lobel Ph: 800-227-2345
 Western Michigan University School of Medicine Clinics
 Jeffrey S Lobel Ph: 800-227-2345
Minnesota
  Minneapolis
 Children's Hospitals and Clinics of Minnesota - Minneapolis
 Bruce C Bostrom Ph: 612-813-5193
 Masonic Cancer Center at University of Minnesota
 Christopher L Moertel Ph: 612-624-2620
  Rochester
 Mayo Clinic Cancer Center
 Carola A. S. Arndt Ph: 507-538-7623
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Betty L Herrington Ph: 601-815-6700
Missouri
  Kansas City
 Children's Mercy Hospital
 Maxine L Hetherington Ph: 816-234-3265
  Saint Louis
 Cardinal Glennon Children's Hospital
 William S Ferguson Ph: 314-268-4000
 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
 Joshua B Rubin Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Nebraska
  Omaha
 Children's Hospital
 Minnie Abromowitch Ph: 402-955-3949
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 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
 Burton E Appel Ph: 201-996-2879
  Livingston
 St. Barnabas Medical Center Cancer Center
 Stacey Rifkin-Zenenberg Ph: 973-926-7230
  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
 Saint Peter's University Hospital
 Stanley Calderwood Ph: 732-745-8600ext6163
  Email: kcovert@saintpetersuh.com
  Newark
 Newark Beth Israel Medical Center
 Peri Kamalakar Ph: 973-926-7230
  Paterson
 St. Joseph's Hospital and Medical Center
 Mary A Bonilla Ph: 973-754-2909
  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
  Albany
 Albany Medical Center Hospital
 Vikramjit S Kanwar Ph: 518-262-3368
  Bronx
 Montefiore Medical Center
 Rosanna J Ricafort Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  Buffalo
 Roswell Park Cancer Institute
 Martin L Brecher Ph: 877-275-7724
  Mineola
 Winthrop University Hospital
 Mark E Weinblatt Ph: 866-946-8476
  New York
 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
 Lisa R Hackney Ph: 585-275-5830
  Stony Brook
 Stony Brook University Cancer Center
 Robert I Parker Ph: 800-862-2215
  Syracuse
 SUNY Upstate Medical University Hospital
 Karol H Kerr Ph: 315-464-5476
  Valhalla
 New York Medical College
 Mehmet F Ozkaynak 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
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Joel A Kaplan Ph: 704-355-2884
 Presbyterian Cancer Center at Presbyterian Hospital
 Paulette C Bryant Ph: 704-384-5369
  Durham
 Duke Cancer Institute
 Susan G Kreissman Ph: 888-275-3853
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Thomas W McLean Ph: 336-713-6771
North Dakota
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Nathan L Kobrinsky 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
 Tanya M Tekautz 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
  Toledo
 Mercy Children's Hospital
 Rama Jasty Ph: 419-251-8210
 Toledo Hospital
 Dagmar T Stein Ph: 419-824-1842
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 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
 Legacy Emanuel Hospital and Health Center and Children's Hospital
 Janice F Olson Ph: 503-413-2560
Pennsylvania
  Bethlehem
 Lehigh Valley Hospital - Muhlenberg
 Philip M Monteleone Ph: 484-884-2201
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Jeffrey S Taylor Ph: 570-271-5251
  Hershey
 Penn State Children's Hospital
 John F Kuttesch Ph: 505-272-6972
  Email: CTO@hmc.psu.edu
  Philadelphia
 Children's Hospital of Philadelphia
 Michael J Fisher Ph: 215-590-2810
 St. Christopher's Hospital for Children
 Gregory E Halligan Ph: 215-427-8991
  Pittsburgh
 Children's Hospital of Pittsburgh of UPMC
 Arthur K Ritchey Ph: 412-692-5573
PR
  Santurce
 San Jorge Children's Hospital
 Luis A Clavell Ph: 888-823-5923
  Email: ctsucontact@westat.com
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Jacqueline M Kraveka Ph: 843-792-9321
  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
  Nashville
 Vanderbilt-Ingram Cancer Center
 Haydar A Frangoul Ph: 800-811-8480
Texas
  Amarillo
 Texas Tech University Health Sciences Center School of Medicine - Amarillo
 Osvaldo Regueira Ph: 806-354-5411
  Austin
 Dell Children's Medical Center of Central Texas
 Sharon K Lockhart Ph: 512-324-8022
  Corpus Christi
 Driscoll Children's Hospital
 M. C Johnson Ph: 361-694-5311
  Dallas
 Medical City Dallas Hospital
 Carl Lenarsky Ph: 972-566-5588
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Naomi J Winick 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
 Lisa R Bomgaars Ph: 713-798-1354
  Email: burton@bcm.edu
 Univeristy of Texas M.D. Anderson Cancer Center
 Soumen Khatua Ph: 713-792-3245
  Lubbock
 Covenant Children's Hospital
 Latha Prasannan Ph: 806-725-8000
  Email: jaccresearch@covhs.org
  San Antonio
 Methodist Children's Hospital of South Texas
 Jaime Estrada Ph: 210-575-7000
 University of Texas Health Science Center at San Antonio
 Anne-Marie R Langevin Ph: 210-567-0653
  Email: che@uthscsa.edu
  Temple
 Scott and White Cancer Institute
 Guy H Grayson Ph: 254-724-5407
Utah
  Salt Lake City
 Primary Children's Medical Center
 Phillip E Barnette Ph: 801-585-5270
Vermont
  Burlington
 Vermont Cancer Center at University of Vermont
 Alan C Homans Ph: 802-656-8990
Virginia
  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
  Roanoke
 Carilion Medical Center for Children at Roanoke Community Hospital
 Mandy M Atkinson Ph: 540-981-7376
Washington
  Seattle
 Children's Hospital and Regional Medical Center - Seattle
 James M Olson Ph: 866-987-2000
  Spokane
 Providence Cancer Center at Sacred Heart Medical Center
 James M Olson Ph: 866-987-2000
  Tacoma
 Mary Bridge Children's Hospital and Health Center - Tacoma
 Robert G Irwin Ph: 888-823-5923
  Email: ctsucontact@westat.com
West Virginia
  Charleston
 West Virginia University Medical School - Charleston
 Allen R Chauvenet Ph: 304-388-9944
Wisconsin
  Green Bay
 St. Vincent Hospital Regional Cancer Center
 John R Hill Ph: 920-433-8889
  Marshfield
 Marshfield Clinic - Marshfield Center
 Michael J McManus Ph: 715-389-4457
  Milwaukee
 Midwest Children's Cancer Center at Children's Hospital of Wisconsin
 Michael E Kelly Ph: 414-805-4380
Australia
South Australia
  North Adelaide
 Women's and Children's Hospital
 Maria L Kirby Ph: (08) 8161 7327
  Email: cywhs.oncsec@health.sa.gov.au
Western Australia
  Perth
 Princess Margaret Hospital for Children
 Catherine H Cole Ph: (08) 9340 8330
  Email: admin@childcancerresearch.com.au
Canada
Alberta
  Edmonton
 University of Alberta Hospital
 Sunil Jayantilal` S Desai Ph: 780-407-6615
  Email: val.taylor@albertahealthservices.ca
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
 Margaret C Yhap Ph: 902-470-8394
Ontario
  Hamilton
 McMaster Children's Hospital at Hamilton Health Sciences
 Carol Portwine Ph: 905-521-2100ext74595
 Carol Portwine Ph: 905-521-2100ext74595
  Ottawa
 Children's Hospital of Eastern Ontario
 Jacqueline M Halton Ph: 613-738-3931
  Toronto
 Hospital for Sick Children
 Eric Bouffet Ph: 416-813-7654ext2027
  Email: jason.mcguire@sickkids.ca
Quebec
  Montreal
 Hopital Sainte Justine
 Yvan Samson Ph: 514-345-4931
 Montreal Children's Hospital at McGill University Health Center
 Sharon B Abish Ph: 514-412-4445
  Email: info@thechildren.com
  Ste-Foy
 Centre de Recherche du Centre Hospitalier de l'Universite Laval
 Bruno Michon Ph: 418-525-4444
Saskatchewan
  Saskatoon
 Saskatoon Cancer Centre at the University of Saskatchewan
 Christopher Mpofu Ph: 306-655-2914
Netherlands
  Den Haag
 Dutch Childhood Oncology Group
 Cornelia E Gidding Ph: 888-823-5923
  Email: ctsucontact@westat.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00392327
Information obtained from ClinicalTrials.gov on June 10, 2013

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.

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