Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00980460
First received: September 18, 2009
Last updated: November 21, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Hepatoblastoma
Stage I Childhood Hepatocellular Carcinoma
Stage II Childhood Hepatocellular Carcinoma
Stage III Childhood Hepatocellular Carcinoma
Stage IV Childhood Hepatocellular Carcinoma
Procedure: Therapeutic Conventional Surgery
Drug: Cisplatin
Drug: Fluorouracil
Drug: Vincristine Sulfate
Drug: Doxorubicin Hydrochloride
Drug: Irinotecan Hydrochloride
Drug: Temsirolimus
Procedure: Liver Transplantation
Other: Laboratory Biomarker Analysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Time Frame: Time from patient enrollment to progression, treatment failure, death from any cause, diagnosis of a second malignant neoplasm, or last follow-up, assessed up to 7 years ] [ Designated as safety issue: No ]
    Estimated by the method of Kaplan and Meier.

  • Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 7 years ] [ Designated as safety issue: Yes ]
    All Grade 3 or 4 or greater non-hematological toxicities as well as any toxicity that requires submission of an Cancer Therapy Evaluation Program Adverse Event Reporting System report will be reported while the patient is on protocol therapy. The frequency of each toxicity type will be quantified as the percent of reporting periods on which the toxicity of the relevant grade is reported.

  • Rate of death [ Time Frame: Possibly, probably or likely related to systemic chemotherapy assessed up to 7 years ] [ Designated as safety issue: No ]
    The estimated on-protocol-therapy death rate and its 95% confidence interval will be reported as the cumulative incidence of on-treatment death and the 95% confidence intervals at four and six month.

  • Disease status at the end of 2 courses of therapy [ Time Frame: Up to 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility of referral for liver transplantation [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    A patient for whom referral is considered appropriate who receives a consultation after enrollment will be considered a success with respect to feasibility.


Estimated Enrollment: 253
Study Start Date: September 2009
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Very low-risk group
Patients undergo surgery and then receive no further treatment.
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: Low-risk group (regimen T)
Patients undergo surgery and then receive adjuvant cisplatin 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.
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Drug: Cisplatin
Given IV
Drug: Fluorouracil
Given IV
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: 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.
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Drug: Cisplatin
Given IV
Drug: Fluorouracil
Given IV
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Drug: Doxorubicin Hydrochloride
Given IV
Procedure: Liver Transplantation
Undergo liver transplant
Other Names:
  • Hepatic Transplantation
  • Liver Grafting
  • Liver Transplant
  • Transplantation of Liver
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: 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. Responding patients then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block and non-responding patients 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.
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Drug: Cisplatin
Given IV
Drug: Fluorouracil
Given IV
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Drug: Doxorubicin Hydrochloride
Given IV
Drug: Irinotecan Hydrochloride
Given IV
Drug: Temsirolimus
Given IV
Other Names:
  • CCI-779
  • Torisel
Procedure: Liver Transplantation
Undergo liver transplant
Other Names:
  • Hepatic Transplantation
  • Liver Grafting
  • Liver Transplant
  • Transplantation of Liver
Other: Laboratory Biomarker Analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980460

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Alyssa T. Reddy    205-934-0309      
Principal Investigator: Alyssa T. Reddy         
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Alyssa T. Reddy    205-934-0309      
Principal Investigator: Alyssa T. Reddy         
United States, Arizona
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Jessica Boklan    602-546-0920      
Principal Investigator: Jessica Boklan         
University of Arizona Health Sciences Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Lisa M. Kopp    520-626-9008      
Principal Investigator: Lisa M. Kopp         
United States, Arkansas
Arkansas Children's Hospital Active, not recruiting
Little Rock, Arkansas, United States, 72202-3591
University of Arkansas for Medical Sciences Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90242
Contact: Robert M. Cooper    626-564-3455      
Principal Investigator: Robert M. Cooper         
Loma Linda University Medical Center Active, not recruiting
Loma Linda, California, United States, 92354
Miller Children's Hospital Recruiting
Long Beach, California, United States, 90806
Contact: Theodore Zwerdling    562-933-5437      
Principal Investigator: Theodore Zwerdling         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Fataneh (Fae) Majlessipour    310-423-8965      
Principal Investigator: Fataneh (Fae) Majlessipour         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas    323-361-4110      
Principal Investigator: Leo Mascarenhas         
Children's Hospital Central California Recruiting
Madera, California, United States, 93636-8762
Contact: Vonda L. Crouse    866-353-5437      
Principal Investigator: Vonda L. Crouse         
Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609-1809
Contact: Carla B. Golden    510-450-7600      
Principal Investigator: Carla B. Golden         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Steven K. Bergstrom    626-564-3455      
Principal Investigator: Steven K. Bergstrom         
Childrens Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Violet Shen    714-997-3000      
Principal Investigator: Violet Shen         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Neyssa M. Marina    650-498-7061    clinicaltrials@med.stanford.edu   
Principal Investigator: Neyssa M. Marina         
Sutter General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Howard M. Katzenstein    888-785-1112      
Principal Investigator: Howard M. Katzenstein         
Rady Children's Hospital - San Diego Active, not recruiting
San Diego, California, United States, 92123
University of California San Francisco Medical Center-Parnassus Recruiting
San Francisco, California, United States, 94143
Contact: Robert E. Goldsby    877-827-3222      
Principal Investigator: Robert E. Goldsby         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Brian S. Greffe    720-777-6672      
Principal Investigator: Brian S. Greffe         
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Jennifer J. Clark    866-775-6246      
Principal Investigator: Jennifer J. Clark         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michael S. Isakoff    860-545-9981      
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Nina S. Kadan-Lottick    203-785-5702      
Principal Investigator: Nina S. Kadan-Lottick         
United States, Delaware
Alfred I duPont Hospital for Children Active, not recruiting
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jeffrey S. Dome    202-884-2549      
Principal Investigator: Jeffrey S. Dome         
Lombardi Comprehensive Cancer Center at Georgetown University Recruiting
Washington, District of Columbia, United States, 20057
Contact: Aziza T. Shad    202-444-0381      
Principal Investigator: Aziza T. Shad         
United States, Florida
Broward Health Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Hector M. Rodriguez-Cortes    954-355-5346      
Principal Investigator: Hector M. Rodriguez-Cortes         
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Emad K. Salman    239-343-5333      
Principal Investigator: Emad K. Salman         
Lee Memorial Health System Withdrawn
Fort Myers, Florida, United States, 33901
University of Florida Active, not recruiting
Gainesville, Florida, United States, 32610
Memorial Healthcare System - Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Iftikhar Hanif    954-265-2234      
Principal Investigator: Iftikhar Hanif         
Nemours Children's Clinic-Jacksonville South Active, not recruiting
Jacksonville, Florida, United States, 32207
Baptist Hospital of Miami Active, not recruiting
Miami, Florida, United States, 33176
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Julio C. Barredo    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Julio C. Barredo         
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti    321-841-7246    CancerClinicalTrials@orlandohealth.com   
Principal Investigator: Vincent F. Giusti         
Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Fouad M. Hajjar    407-303-5623      
Principal Investigator: Fouad M. Hajjar         
Nemours Children's Clinic - Orlando Withdrawn
Orlando, Florida, United States, 32806
Nemours Children's Hospital Active, not recruiting
Orlando, Florida, United States, 32827
UF Cancer Center at Orlando Health Withdrawn
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Pensacola Active, not recruiting
Pensacola, Florida, United States, 32504
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Gregory A. Hale    727-767-2423    HamblinF@allkids.org   
Principal Investigator: Gregory A. Hale         
Saint Joseph Children's Hospital of Tampa Active, not recruiting
Tampa, Florida, United States, 33607
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Glen Lew    404-785-1112      
Principal Investigator: Glen Lew         
Memorial University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: J. M. Johnston    912-350-8568      
Principal Investigator: J. M. Johnston         
United States, Hawaii
Kapiolani Medical Center for Women and Children Active, not recruiting
Honolulu, Hawaii, United States, 96826
Tripler Army Medical Center Active, not recruiting
Honolulu, Hawaii, United States, 96859
University of Hawaii Cancer Center Withdrawn
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Luke's Mountain States Tumor Institute Active, not recruiting
Boise, Idaho, United States, 83712
United States, Illinois
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Yasmin C. Gosiengfiao    773-880-4562      
Principal Investigator: Yasmin C. Gosiengfiao         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Susan L. Cohn    773-834-7424      
Principal Investigator: Susan L. Cohn         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary L. Schmidt    312-355-3046      
Principal Investigator: Mary L. Schmidt         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Ricarchito B. Manera    708-226-4357      
Principal Investigator: Ricarchito B. Manera         
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Rebecca E. McFall    847-723-7570      
Principal Investigator: Rebecca E. McFall         
Advocate Lutheran General Hospital. Withdrawn
Park Ridge, Illinois, United States, 60068
Advocate Children's Hospital-Park Ridge Active, not recruiting
Park Ridge, Illinois, United States, 60068
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61602
Contact: Karen S. Fernandez    309-655-3258      
Principal Investigator: Karen S. Fernandez         
Southern Illinois University Recruiting
Springfield, Illinois, United States, 62702
Contact: Gregory P. Brandt    217-545-7929      
Principal Investigator: Gregory P. Brandt         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robert J. Fallon    317-274-2552      
Principal Investigator: Robert J. Fallon         
Saint Vincent Hospital and Health Services Active, not recruiting
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Wendy L. Woods-Swafford    515-241-6729      
Principal Investigator: Wendy L. Woods-Swafford         
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Ayman A. El-Sheikh    800-237-1225      
Principal Investigator: Ayman A. El-Sheikh         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Lars M. Wagner    859-257-3379      
Principal Investigator: Lars M. Wagner         
Kosair Children's Hospital Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Children's Hospital New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Lolie C. Yu    504-894-5377      
Principal Investigator: Lolie C. Yu         
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Craig Lotterman    888-562-4763      
Principal Investigator: Craig Lotterman         
Tulane University Health Sciences Center Withdrawn
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center Active, not recruiting
Bangor, Maine, United States, 04401
Maine Children's Cancer Program Recruiting
Scarborough, Maine, United States, 04074
Contact: Eric C. Larsen    207-396-8090    wrighd@mmc.org   
Principal Investigator: Eric C. Larsen         
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Joseph M. Wiley    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Joseph M. Wiley         
Walter Reed National Military Medical Center Active, not recruiting
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Dana-Farber Cancer Institute Active, not recruiting
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center Active, not recruiting
Boston, Massachusetts, United States, 02114
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Christopher P. Keuker    508-856-3216    cancer.research@umassmed.edu   
Principal Investigator: Christopher P. Keuker         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Brenda J. Kitchen    248-551-7695      
Principal Investigator: Brenda J. Kitchen         
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Jeffrey W. Taub    313-576-9363      
Principal Investigator: Jeffrey W. Taub         
Michigan State University Clinical Center Recruiting
East Lansing, Michigan, United States, 48824-7016
Contact: Renuka Gera    517-975-9547      
Principal Investigator: Renuka Gera         
Hurley Medical Center Active, not recruiting
Flint, Michigan, United States, 48502
Helen DeVos Children's Hospital at Spectrum Health Active, not recruiting
Grand Rapids, Michigan, United States, 49503
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Jeffrey S. Lobel    800-227-2345      
Principal Investigator: Jeffrey S. Lobel         
Kalamazoo Center for Medical Studies Recruiting
Kalamazoo, Michigan, United States, 49008
Contact: Jeffrey S. Lobel    800-227-2345      
Principal Investigator: Jeffrey S. Lobel         
United States, Minnesota
University of Minnesota Medical Center-Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Brenda J. Weigel    612-624-2620      
Principal Investigator: Brenda J. Weigel         
Children's Hospitals and Clinics of Minnesota - Minneapolis Active, not recruiting
Minneapolis, Minnesota, United States, 55404
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Carola A. Arndt    507-538-7623      
Principal Investigator: Carola A. Arndt         
United States, Mississippi
University of Mississippi Medical Center Active, not recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
University of Missouri - Ellis Fischel Withdrawn
Columbia, Missouri, United States, 65212
Columbia Regional Active, not recruiting
Columbia, Missouri, United States, 65201
The Childrens Mercy Hospital Active, not recruiting
Kansas City, Missouri, United States, 64108
Saint John's Mercy Medical Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman    913-948-5588      
Principal Investigator: Bethany G. Sleckman         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: David B. Wilson    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: David B. Wilson         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Minnie Abromowitch    402-955-3949      
Principal Investigator: Minnie Abromowitch         
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Minnie Abromowitch    402-955-3949      
Principal Investigator: Minnie Abromowitch         
United States, Nevada
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Nik Farahana N. Rashid    702-384-0013      
Principal Investigator: Nik Farahana N. Rashid         
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
Children's Specialty Center of Nevada II Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Sara Chaffee    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Sara Chaffee         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Michael B. Harris    201-996-2879      
Principal Investigator: Michael B. Harris         
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Stanley Calderwood    732-745-8600ext6163    kcovert@saintpetersuh.com   
Principal Investigator: Stanley Calderwood         
UMDNJ - Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Richard A. Drachtman    732-235-8675      
Principal Investigator: Richard A. Drachtman         
Newark Beth Israel Medical Center Active, not recruiting
Newark, New Jersey, United States, 07112
Saint Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary A. Bonilla    973-754-2909      
Principal Investigator: Mary A. Bonilla         
Overlook Hospital Recruiting
Summit, New Jersey, United States, 07902
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Koh B. Boayue    505-272-6972      
Principal Investigator: Koh B. Boayue         
United States, New York
Albany Medical Center Active, not recruiting
Albany, New York, United States, 12208
Montefiore Medical Center - Moses Campus Active, not recruiting
Bronx, New York, United States, 10467-2490
Roswell Park Cancer Institute Active, not recruiting
Buffalo, New York, United States, 14263
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mark E. Weinblatt    866-946-8476      
Principal Investigator: Mark E. Weinblatt         
The Steven and Alexandra Cohen Children's Medical Center of New York Active, not recruiting
New Hyde Park, New York, United States, 11040
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Alice Lee    212-305-8615      
Principal Investigator: Alice Lee         
Memorial Sloan-Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
New York University Langone Medical Center Active, not recruiting
New York, New York, United States, 10016
University of Rochester Active, not recruiting
Rochester, New York, United States, 14642
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Karol H. Kerr    315-464-5476      
Principal Investigator: Karol H. Kerr         
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mehmet F. Ozkaynak    914-594-3794      
Principal Investigator: Mehmet F. Ozkaynak         
United States, North Carolina
Mission Hospital-Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Douglas J. Scothorn    828-213-4150      
Principal Investigator: Douglas J. Scothorn         
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Stuart H. Gold    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Stuart H. Gold         
Carolinas Medical Center Active, not recruiting
Charlotte, North Carolina, United States, 28203
Novant Health Presbyterian Medical Center Active, not recruiting
Charlotte, North Carolina, United States, 28204
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Thomas W. McLean    336-713-6771      
Principal Investigator: Thomas W. McLean         
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Steven J. Kuerbitz    330-543-3193      
Principal Investigator: Steven J. Kuerbitz         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: John P. Perentesis    513-636-2799      
Principal Investigator: John P. Perentesis         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Margaret C. Thompson    866-223-8100      
Principal Investigator: Margaret C. Thompson         
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Yousif (Joe) H. Matloub    216-844-5437      
Principal Investigator: Yousif (Joe) H. Matloub         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark A. Ranalli    614-722-2708      
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Emmett H. Broxson    800-228-4055      
Principal Investigator: Emmett H. Broxson         
Mercy Children's Hospital Active, not recruiting
Toledo, Ohio, United States, 43608
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-2560      
Principal Investigator: Janice F. Olson         
Legacy Emanuel Hospital and Health Center Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-2560      
Principal Investigator: Janice F. Olson         
Oregon Health and Science University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Hershey Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Lisa M. McGregor    717-531-3779    CTO@hmc.psu.edu   
Principal Investigator: Lisa M. McGregor         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Edward F. Attiyeh    215-590-2810      
Principal Investigator: Edward F. Attiyeh         
Saint Christopher's Hospital for Children Active, not recruiting
Philadelphia, Pennsylvania, United States, 19134
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Arthur K. Ritchey    412-692-5573      
Principal Investigator: Arthur K. Ritchey         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Jennifer J. Greene Welch    401-444-1488      
Principal Investigator: Jennifer J. Greene Welch         
United States, South Carolina
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Ronnie W. Neuberg    803-434-3680      
Principal Investigator: Ronnie W. Neuberg         
BI-LO Charities Children's Cancer Center Active, not recruiting
Greenville, South Carolina, United States, 29605
Greenville Cancer Treatment Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Cary E. Stroud    864-241-6251      
Principal Investigator: Cary E. Stroud         
United States, Tennessee
T C Thompson Children's Hospital Active, not recruiting
Chattanooga, Tennessee, United States, 37403
East Tennessee Childrens Hospital Active, not recruiting
Knoxville, Tennessee, United States, 37916
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Wayne L. Furman    901-595-4644      
Principal Investigator: Wayne L. Furman         
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Scott C. Borinstein    800-811-8480      
Principal Investigator: Scott C. Borinstein         
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Sharon K. Lockhart    512-324-8022      
Principal Investigator: Sharon K. Lockhart         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: M. C. Johnson    361-694-5311      
Principal Investigator: M. C. Johnson         
Medical City Dallas Hospital Active, not recruiting
Dallas, Texas, United States, 75230
University of Texas Southwestern Medical Center Active, not recruiting
Dallas, Texas, United States, 75390
Brooke Army Medical Center Active, not recruiting
Fort Sam Houston, Texas, United States, 78234
Cook Children's Medical Center Active, not recruiting
Fort Worth, Texas, United States, 76104
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Patrick A. Thompson    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Patrick A. Thompson         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Patrick A. Thompson    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Patrick A. Thompson         
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Jaime Estrada    210-575-7000      
Principal Investigator: Jaime Estrada         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Anne-Marie R. Langevin    210-450-3800    CTO@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
Scott and White Memorial Hospital Active, not recruiting
Temple, Texas, United States, 76508
United States, Utah
Primary Children's Hospital Active, not recruiting
Salt Lake City, Utah, United States, 84113
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kimberly P. Dunsmore    434-243-6143      
Principal Investigator: Kimberly P. Dunsmore         
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Marshall A. Schorin    703-208-6650      
Principal Investigator: Marshall A. Schorin         
Childrens Hospital-King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Eric J. Lowe    757-668-7243      
Principal Investigator: Eric J. Lowe         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Gita V. Massey    804-628-1939      
Principal Investigator: Gita V. Massey         
Carilion Clinic Children's Hospital Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mandy M. Atkinson    540-981-7376      
Principal Investigator: Mandy M. Atkinson         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas S. Hawkins    866-987-2000      
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Judy L. Felgenhauer    800-228-6618    HopeBeginsHere@providence.org   
Principal Investigator: Judy L. Felgenhauer         
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Melissa A. Forouhar    253-968-0129    mamcdci@amedd.army.mil   
Principal Investigator: Melissa A. Forouhar         
Mary Bridge Children's Hospital and Health Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Robert G. Irwin    253-403-3229      
Principal Investigator: Robert G. Irwin         
United States, West Virginia
West Virginia University Charleston Recruiting
Charleston, West Virginia, United States, 25304
Contact: Howard M. Grodman    304-388-9944      
Principal Investigator: Howard M. Grodman         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Active, not recruiting
Madison, Wisconsin, United States, 53792
Midwest Children's Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Sachin S. Jogal    414-805-4380      
Principal Investigator: Sachin S. Jogal         
Australia, New South Wales
John Hunter Children's Hospital Recruiting
Hunter Regional Mail Centre, New South Wales, Australia, 2310
Contact: Elizabeth L. Hesketh    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Elizabeth L. Hesketh         
The Children's Hospital at Westmead Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Geoffrey B. McCowage    61-2-9845 1400      
Principal Investigator: Geoffrey B. McCowage         
Australia, South Australia
Women's and Children's Hospital-Adelaide Active, not recruiting
North Adelaide, South Australia, Australia, 5006
Australia, Western Australia
Princess Margaret Hospital for Children Active, not recruiting
Perth, Western Australia, Australia, 6008
Brazil
Instituto De Oncologia Pediatrica Terminated
Sao Paulo, Brazil, 04023-062
Canada, Alberta
Alberta Children's Hospital Active, not recruiting
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
British Columbia Children's Hospital Active, not recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba Active, not recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
IWK Health Centre Active, not recruiting
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Chedoke-McMaster Hospitals Recruiting
Hamilton, Ontario, Canada, L8S 4L8
Contact: Carol Portwine    905-521-2100ext74595      
Principal Investigator: Carol Portwine         
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine    905-521-2100ext74595      
Principal Investigator: Carol Portwine         
Cancer Centre of Southeastern Ontario at Kingston General Hospital Active, not recruiting
Kingston, Ontario, Canada, K7L 5P9
Children's Hospital of Eastern Ontario Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children Active, not recruiting
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Centre Hospitalier Universitaire Sainte-Justine Active, not recruiting
Montreal, Quebec, Canada, H3T 1C5
The Montreal Children's Hospital of the MUHC Active, not recruiting
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire de Quebec Active, not recruiting
Ste-Foy, Quebec, Canada, G1V 4G2
Canada, Saskatchewan
Saskatoon Cancer Centre Active, not recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Puerto Rico
San Jorge Children's Hospital Active, not recruiting
San Juan, Puerto Rico, 00912
Sponsors and Collaborators
Investigators
Principal Investigator: Howard Katzenstein Children's Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00980460     History of Changes
Obsolete Identifiers: NCT02265692
Other Study ID Numbers: NCI-2011-01975, NCI-2011-01975, CDR0000654889, COG-AHEP0731, AHEP0731, AHEP0731, U10CA098543, U10CA180886
Study First Received: September 18, 2009
Last Updated: November 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatoblastoma
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Camptothecin
Cisplatin
Doxorubicin
Everolimus
Fluorouracil
Irinotecan
Liposomal doxorubicin
Liver Extracts
Sirolimus
Vincristine
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents

ClinicalTrials.gov processed this record on November 25, 2014