Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITissue collection/Repository, TreatmentActive21 and underNCINCI-2011-01975
CDR0000654889, COG-AHEP0731, AHEP0731, U10CA180886, U10CA098543, NCT00980460

Trial Description

Summary

This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary liver transplant are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy.

Further Study Information

PRIMARY OBJECTIVES:

I. To estimate the event-free survival (EFS) in children with stage I (non-pure fetal histology [PFH], non-small cell undifferentiated [SCU]) and stage II (non-SCU) hepatoblastoma treated with surgical resection followed by 2 cycles of cisplatin, fluorouracil, and vincristine sulfate (C5V).

II. To determine the feasibility and toxicity of adding doxorubicin hydrochloride to the chemotherapy regimen of C5V for children with intermediate-risk hepatoblastoma.

III. To estimate the response rate to vincristine (vincristine sulfate), irinotecan (irinotecan hydrochloride), and temsirolimus in previously untreated children with high-risk, metastatic hepatoblastoma.

IV. To determine whether timely (between diagnosis and end of second cycle of chemotherapy) consultation with a treatment center with surgical expertise in major pediatric liver resection and transplant can be achieved in 70% of patients with potentially unresectable hepatoblastoma.

V. To foster the collection of tumor tissue and biologic samples to facilitate translational research and to provide data that may aid in risk-adapted approaches for subsequent clinical trials.

SECONDARY OBJECTIVES:

I. To estimate the EFS of patients with stage I PFH treated with surgery alone. II. To determine whether orthotopic liver transplantation (OLT) can be accomplished after successful referral and completion of 4 cycles of initial chemotherapy.

III. To estimate the 2-year EFS for patients once identified as candidates for possible OLT, the 2-year EFS for patients referred to a transplant center that are resected without OLT, and the 2-year EFS for patients referred to a transplant center who receive OLT.

IV. To register children with hepatoblastoma who receive OLT with PLUTO (Pediatric Liver Unresectable Tumor Observatory), an international cooperative registry for children transplanted for liver tumors.

V. To determine if PRETEXT grouping can predict tumor resectability. VI. To monitor the concordance between institutional assessment of PRETEXT grouping and PRETEXT grouping as performed by expert panel review.

VII. To estimate the proportion of stage IV patients who have surgical resection of metastatic pulmonary lesions.

VIII. To determine the proportion and estimate the EFS of patients with potentially poor prognostic factors including alpha fetoprotein (AFP) < 100 ng/mL at diagnosis, microscopic positive surgical margins, surgical complications, multifocal tumors, microscopic vascular invasion, macrotrabecular histologic subtype, and SCU histologic subtype.

OUTLINE: Patients are assigned to 1 of 4 treatment groups according to risk group.

VERY LOW-RISK GROUP: Patients undergo surgery and receive no further treatment.

LOW-RISK GROUP: (regimen T) Patients undergo surgery and then receive adjuvant cisplatin intravenously (IV) over 6 hours on day 1, fluorouracil IV on day 2, and vincristine sulfate IV on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

INTERMEDIATE-RISK GROUP: (regimen F) Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV on day 2, vincristine sulfate IV on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD.

HIGH-RISK GROUP: (regimen H) Patients receive up front VIT chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD.

After completion of study therapy, patients who receive chemotherapy are followed up periodically for at least 4 years.

Eligibility Criteria

Inclusion Criteria:

  • Patients must be newly diagnosed with histologically-proven hepatoblastoma
  • In emergency situations when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled on AHEP0731 without a biopsy
  • Clinical situations in which such emergent treatment may be indicated include, but are not limited to, the following circumstances:
  • Anatomic or mechanical compromise of critical organ function by tumor (eg, respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc)
  • Uncorrectable coagulopathy
  • For a patient to maintain eligibility for AHEP0731 when emergent treatment is given, the following must occur:
  • The patient must have a clinical diagnosis of hepatoblastoma, including an elevated alpha fetoprotein, and must meet all AHEP0731 eligibility criteria at the time of emergent treatment
  • Patient must be enrolled on AHEP0731 prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP0731 enrollment
  • If the patient receives AHEP0731 chemotherapy PRIOR to undergoing a diagnostic biopsy, pathologic review of material obtained in the future during either biopsy or surgical resection must either confirm the diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be included in the analysis of the study aims
  • Patients will be staged for risk classification and treatment at diagnosis using Children's Oncology Group (COG) staging guidelines
  • At the time of study enrollment, the patient's treatment regimen must be identified; if the patient's primary tumor was resected prior to the day of enrollment and a blood specimen for the determination of serum alpha fetoprotein was not obtained prior to that surgery, the patient will be considered to have alpha fetoprotein of greater than 100 ng/mL for the purpose of treatment assignment; if tumor samples obtained prior to the date of enrollment were not sufficient to determine whether small cell undifferentiated (SCU) histology was present, treatment assignment will be made assuming SCU is not present in the tumor
  • For patients with stage I or II disease, specimens for rapid central review have been submitted and the rapid central review diagnosis and staging must be available to be provided on the AHEP0731 eligibility case report form (CRF)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Patients may have had surgical resection of some or all sites of hepatoblastoma prior to enrollment
  • Organ function requirements are not required for enrolled patients who are stage I, PFH and will not be receiving chemotherapy
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR serum creatinine based on age/gender as follows:
  • 1 month to < 6 months: 0.4 mg/dL
  • 6 months to < 1 year: 0.5 mg/dL
  • 1 to < 2 years: 0.6 mg/dL
  • 2 to < 6 years: 0.8 mg/dL
  • 6 to < 10 years: 1 mg/dL
  • 10 to < 13 years: 1.2 mg/dL
  • 13 to < 16 years: 1.5 mg/dL (male) or 1.4 mg/dL (female)
  • >= 16 years: 1.7 mg/dL (male) 1.4 mg/dL (female)
  • Total bilirubin < 1.5 x upper limit of normal (ULN) for age
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x ULN for age
  • Absolute neutrophil count (ANC) > 750/uL
  • Platelet count > 75,000/uL
  • Shortening fraction >= 27% by echocardiogram
  • Ejection fraction >= 47% by radionuclide angiogram (multi gated acquisition scan [MUGA]); Note: the echocardiogram (or MUGA) may be done within 28 days prior to enrollment
  • Serum triglyceride level =< 300 mg/dL (=< 3.42 mmol/L)
  • Serum cholesterol level =< 300 mg/dL (7.75 mmol/L)
  • Random or fasting blood glucose within the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then a follow-up fasting blood glucose can be obtained and must be within the upper normal limits for age
  • Normal pulmonary function tests (including diffusing capacity of the lungs for carbon monoxide [DLCO]) if there is clinical indication for determination (e.g. dyspnea at rest, known requirement for supplemental oxygen); Note: for patients who do not have respiratory symptoms or requirement for supplemental oxygen, pulmonary function tests (PFTs) are NOT required
  • Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and if seizures are well controlled
  • Prothrombin time (PT) < 1.2 x ULN
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Patients with stage I or II disease who do not have specimens submitted for rapid central pathology review by day 14 after initial surgical resection
  • Patients that have been previously treated with chemotherapy for hepatoblastoma or other hepatoblastoma-directed therapy (eg, radiation therapy, biologic agents, local therapy [embolization, radiofrequency ablation, laser]) are not eligible
  • Patients who have received any prior chemotherapy are not eligible
  • Patients who are currently receiving another investigational drug are not eligible
  • Patients who are currently receiving other anticancer agents are not eligible
  • Patients who have previously received a solid organ transplant are not eligible
  • Patients who have an uncontrolled infection are not eligible
  • Females who are pregnant or breast feeding are not eligible for this study
  • Female patients of childbearing potential are not eligible unless a negative pregnancy text result has been obtained
  • Males and females of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method
  • Patients receiving corticosteroids are not eligible; patients must have been off corticosteroids for 7 days prior to start of chemotherapy
  • Patients who are currently receiving enzyme inducing anticonvulsants are not eligible
  • Patients must not be receiving any of the following potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors: erythromycin, clarithromycin, azithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, grapefruit juice or St. John's wort
  • Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, warfarin and others) are not eligible
  • Patients who are currently receiving angiotensin-converting enzymes (ACE) inhibitors are not eligible
  • Patients must not have had major surgery within 6 weeks prior to enrollment on the high risk stratum; patients with history of recent minor surgical procedures (vascular catheter placement, bone marrow evaluation, laparoscopic surgery, liver tumor biopsy) will be eligible

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

    Howard Katzenstein, Principal 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

    Arizona
    Phoenix

    Phoenix Children's Hospital

    Jessica Boklan
    Ph: 602-546-0920

    Tucson

    Arizona Cancer Center at University of Arizona Health Sciences Center

    Lisa M Kopp
    Ph: 520-626-9008

    Arkansas
    Little Rock

    Arkansas Children's Hospital at the University of Arkansas for Medical Sciences

    David L Becton
    Ph: 501-364-7373

    California
    Downey

    Southern California Permanente Medical Group

    Robert M Cooper
    Ph: 626-564-3455

    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

    Theodore Zwerdling
    Ph: 562-933-5600

    Los Angeles

    Children's Hospital Los Angeles

    Leo Mascarenhas
    Ph: 323-361-4110

    Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Fataneh (Fae) Majlessipour
    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

    Carla B Golden
    Ph: 510-450-7600

    Kaiser Permanente-Oakland

    Steven K Bergstrom
    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

    Sutter Cancer Center

    Howard M Katzenstein
    Ph: 888-785-1112

    San Diego

    Rady Children's Hospital - San Diego

    William D Roberts
    Ph: 858-966-5934

    San Francisco

    UCSF Helen Diller Family Comprehensive Cancer Center

    Robert E Goldsby
    Ph: 877-827-3222

    Colorado
    Aurora

    Children's Hospital Colorado Center for Cancer and Blood Disorders

    Brian S Greffe
    Ph: 720-777-6672

    Denver

    Presbyterian - St. Luke's Medical Center

    Jennifer J Clark
    Ph: 866-775-6246

    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

    Ramamoorthy Nagasubramanian
    Ph: 407-650-7150

    District of Columbia
    Washington

    Children's National Medical Center

    Jeffrey S Dome
    Ph: 202-884-2549

    Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Aziza T Shad
    Ph: 202-444-0381

    Florida
    Fort Lauderdale

    Broward General Medical Center Cancer Center

    Hector M Rodriguez-Cortes
    Ph: 954-355-5346

    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

    Ramamoorthy Nagasubramanian
    Ph: 407-650-7150

    Miami

    Baptist-South Miami Regional Cancer Program

    Doured Daghistani
    Ph: 800-599-2456
    Email: cancerinfo@baptisthealth.net

    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

    Ramamoorthy Nagasubramanian
    Ph: 407-650-7150

    Pensacola

    Nemours Children's Clinic - Pensacola

    Ramamoorthy Nagasubramanian
    Ph: 407-650-7150

    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

    Dana A Obzut
    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

    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

    Tripler Army Medical Center

    Jeremy V Edwards
    Ph: 808-433-6336

    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

    Yasmin C Gosiengfiao
    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

    Park Ridge

    Advocate Children's Hospital-Park Ridge

    Rebecca E McFall
    Ph: 847-723-7570

    Peoria

    Saint Jude Midwest Affiliate

    Karen S Fernandez
    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: 515-241-6729

    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

    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

    Ochsner Cancer Institute at Ochsner Clinic Foundation

    Craig Lotterman
    Ph: 888-562-4763

    Maine
    Scarborough

    Maine Children's Cancer Program at Barbara Bush Children's Hospital

    Eric C Larsen
    Ph: 207-396-8090
    Email: wrighd@mmc.org

    Maryland
    Baltimore

    Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

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

    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

    Worcester

    UMASS Memorial Cancer Center - University Campus

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

    Michigan
    Ann Arbor

    C.S. Mott Children's Hospital at University of Michigan Medical Center

    Brenda J Kitchen
    Ph: 248-551-7695

    Detroit

    Wayne State University

    Jeffrey W Taub
    Ph: 313-576-9363

    East Lansing

    Breslin Cancer Center at Ingham Regional Medical Center

    Renuka Gera
    Ph: 517-975-9547

    Flint

    Hurley Medical Center

    Susumu Inoue
    Ph: 888-606-6556

    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

    Brenda J Weigel
    Ph: 612-624-2620

    Rochester

    Mayo Clinic Cancer Center

    Carola A. S. Arndt
    Ph: 507-538-7623

    Mississippi
    Jackson

    University of Mississippi Cancer Clinic

    Gail C Megason
    Ph: 601-815-6700

    Missouri
    Columbia

    Columbia Regional Hospital

    Thomas W Loew
    Ph: 573-882-7440

    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

    David B Wilson
    Ph: 800-600-3606
    Email: info@siteman.wustl.edu

    Nebraska
    Omaha

    Children's Hospital

    Minnie Abromowitch
    Ph: 402-955-3949

    Fred and Pamela Buffett Cancer Center

    Minnie Abromowitch
    Ph: 402-955-3949

    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

    Sunrise Hospital and Medical Center

    Nik Farahana N Rashid
    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

    Michael B Harris
    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

    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

    Peter D Cole
    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 Hyde Park

    Schneider Children's Hospital

    Carolyn F Levy
    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

    Mount Sinai Medical Center

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

    New York University Medical Center

    Linda Granowetter
    Ph: 212-263-4434
    Email: prmc.coordinator@nyumc.org

    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
    Asheville

    Mission Hospitals - Memorial Campus

    Douglas J Scothorn
    Ph: 828-213-4150

    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

    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

    Greenville

    Leo W. Jenkins Cancer Center at ECU Medical School

    George E Hucks
    Ph: 252-744-2391

    Winston-Salem

    Wake Forest University Comprehensive Cancer Center

    Thomas W McLean
    Ph: 336-713-6771

    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

    Toledo

    Mercy Children's Hospital

    Rama Jasty
    Ph: 419-251-8210

    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

    Suman Malempati
    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
    Hershey

    Penn State Children's Hospital

    Lisa M McGregor
    Ph: 717-531-6012

    Philadelphia

    Children's Hospital of Philadelphia

    Edward F Attiyeh
    Ph: 215-590-2810

    St. Christopher's Hospital for Children

    Akash Nahar
    Ph: 215-427-8991

    Pittsburgh

    Children's Hospital of Pittsburgh of UPMC

    Arthur K Ritchey
    Ph: 412-692-5573

    PR
    San Juan

    San Jorge Children's Hospital

    Luis A Clavell
    Ph: 888-823-5923
    Email: ctsucontact@westat.com

    Rhode Island
    Providence

    Rhode Island Hospital Comprehensive Cancer Center

    Jennifer J Greene Welch
    Ph: 401-444-1488

    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

    Cary E Stroud
    Ph: 864-241-6251

    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

    Scott C Borinstein
    Ph: 800-811-8480

    Texas
    Austin

    Dell Children's Medical Center of Central Texas

    Amy C Fowler
    Ph: 214-648-7097

    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

    Jonathan E Wickiser
    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

    Patrick A Thompson
    Ph: 877-668-0683
    Email: cancerclinicaltrials@med.unc.edu

    San Antonio

    Children's Hospital of San Antonio

    Patrick A Thompson
    Ph: 877-668-0683
    Email: cancerclinicaltrials@med.unc.edu

    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: 210-450-3800
    Email: CTO@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

    Virginia
    Charlottesville

    University of Virginia Cancer Center

    Kimberly P Dunsmore
    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

    Gita V Massey
    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

    Douglas S Hawkins
    Ph: 866-987-2000

    Spokane

    Providence Cancer Center at Sacred Heart Medical Center

    Judy L Felgenhauer
    Ph: 800-228-6618
    Email: HopeBeginsHere@providence.org

    Tacoma

    Madigan Army Medical Center - Tacoma

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

    Mary Bridge Children's Hospital and Health Center - Tacoma

    Robert G Irwin
    Ph: 253-403-3229

    West Virginia
    Charleston

    West Virginia University Medical School - Charleston

    Howard M Grodman
    Ph: 304-388-9944

    Wisconsin
    Madison

    University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Kenneth B DeSantes
    Ph: 608-262-5223

    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

    Geoffrey B McCowage
    Ph: 61-2-9845 1400

    Westmead

    Children's Hospital at Westmead

    Geoffrey B McCowage
    Ph: 61-2-9845 1400

    Canada

    Alberta
    Calgary

    Alberta Children's Hospital

    Douglas R Strother
    Ph: 403-220-6898
    Email: research4kids@ucalgary.ca

    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

    Carol Portwine
    Ph: 905-521-2100ext74595

    Kingston

    Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Mariana P Silva
    Ph: 613-544-2630

    Ottawa

    Children's Hospital of Eastern Ontario

    Jacqueline M Halton
    Ph: 613-738-3931

    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

    Quebec

    Centre de Recherche du Centre Hospitalier de l'Universite Laval

    Bruno Michon
    Ph: 418-525-4444

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00980460
    ClinicalTrials.gov processed this data on May 11, 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.