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Trial record 2 of 19 for:    hepatoblastoma | Recruiting, Not yet recruiting, Available Studies

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00980460
Recruitment Status : Recruiting
First Posted : September 21, 2009
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
PRETEXT Stage 1 Hepatoblastoma PRETEXT Stage 2 Hepatoblastoma PRETEXT Stage 3 Hepatoblastoma PRETEXT Stage 4 Hepatoblastoma Drug: Cisplatin Drug: Doxorubicin Hydrochloride Drug: Fluorouracil Drug: Irinotecan Hydrochloride Other: Laboratory Biomarker Analysis Procedure: Liver Transplantation Drug: Temsirolimus Procedure: Therapeutic Conventional Surgery Drug: Vincristine Sulfate Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 253 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : September 14, 2009
Estimated Primary Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fluracil
  • 5-FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluracil
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Drug: Irinotecan Hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • Camptothecin 11
  • Camptothecin-11
  • CPT 11
  • CPT-11
  • Irinomedac
  • U-101440E
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Liver Transplantation
Undergo liver transplant
Other Names:
  • Hepatic Transplantation
  • Liver Grafting
  • Liver Transplant
  • Transplantation of Liver
Drug: Temsirolimus
Given IV
Other Names:
  • CCI-779
  • CCI-779 Rapamycin Analog
  • Cell Cycle Inhibitor 779
  • Rapamycin Analog
  • Rapamycin Analog CCI-779
  • Torisel
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate
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. (closed to accrual as of 3/12/2012)
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fluracil
  • 5-FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluracil
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Liver Transplantation
Undergo liver transplant
Other Names:
  • Hepatic Transplantation
  • Liver Grafting
  • Liver Transplant
  • Transplantation of Liver
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate
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.
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fluracil
  • 5-FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluracil
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate
Experimental: Very low-risk group
Patients undergo surgery and then receive no further treatment.
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Therapeutic Conventional Surgery
Undergo surgery



Primary Outcome Measures :
  1. 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 ]
    Estimated by the method of Kaplan and Meier.

  2. Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 7 years ]
    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.

  3. Rate of death [ Time Frame: Possibly, probably or likely related to systemic chemotherapy assessed up to 7 years ]
    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.

  4. Disease status at the end of 2 courses of therapy [ Time Frame: Up to 42 days ]

Secondary Outcome Measures :
  1. Feasibility of referral for liver transplantation [ Time Frame: Up to 7 years ]
    A patient for whom referral is considered appropriate who receives a consultation after enrollment will be considered a success with respect to feasibility.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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)
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores 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) or 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980460


  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Suspended
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham Cancer Center Active, not recruiting
Birmingham, Alabama, United States, 35233
University of South Alabama Suspended
Mobile, Alabama, United States, 36604
United States, Arizona
Phoenix Childrens Hospital Suspended
Phoenix, Arizona, United States, 85016
The University of Arizona Medical Center-University Campus Suspended
Tucson, Arizona, United States, 85724
United States, Arkansas
Arkansas Children's Hospital Suspended
Little Rock, Arkansas, United States, 72202-3591
University of Arkansas for Medical Sciences Active, not recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group Suspended
Downey, California, United States, 90242
Loma Linda University Medical Center Suspended
Loma Linda, California, United States, 92354
Miller Children's and Women's Hospital Long Beach Suspended
Long Beach, California, United States, 90806
Children's Hospital Los Angeles Suspended
Los Angeles, California, United States, 90027
Cedars Sinai Medical Center Suspended
Los Angeles, California, United States, 90048
Children's Hospital Central California Suspended
Madera, California, United States, 93636-8762
Children's Hospital and Research Center at Oakland Suspended
Oakland, California, United States, 94609-1809
Kaiser Permanente-Oakland Suspended
Oakland, California, United States, 94611
Children's Hospital of Orange County Suspended
Orange, California, United States, 92868
Lucile Packard Children's Hospital Stanford University Suspended
Palo Alto, California, United States, 94304
Sutter Medical Center Sacramento Suspended
Sacramento, California, United States, 95816
University of California Davis Comprehensive Cancer Center Suspended
Sacramento, California, United States, 95817
Rady Children's Hospital - San Diego Suspended
San Diego, California, United States, 92123
Naval Medical Center -San Diego Suspended
San Diego, California, United States, 92134
UCSF Medical Center-Parnassus Active, not recruiting
San Francisco, California, United States, 94143
UCSF Medical Center-Mission Bay Suspended
San Francisco, California, United States, 94158
Santa Barbara Cottage Hospital Suspended
Santa Barbara, California, United States, 93102
United States, Colorado
Children's Hospital Colorado Suspended
Aurora, Colorado, United States, 80045
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Suspended
Denver, Colorado, United States, 80218
United States, Connecticut
Connecticut Children's Medical Center Suspended
Hartford, Connecticut, United States, 06106
Yale University Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, Delaware
Alfred I duPont Hospital for Children Suspended
Wilmington, Delaware, United States, 19803
United States, District of Columbia
MedStar Georgetown University Hospital Suspended
Washington, District of Columbia, United States, 20007
Children's National Medical Center Suspended
Washington, District of Columbia, United States, 20010
United States, Florida
Broward Health Medical Center Suspended
Fort Lauderdale, Florida, United States, 33316
Lee Memorial Health System Active, not recruiting
Fort Myers, Florida, United States, 33901
Golisano Children's Hospital of Southwest Florida Suspended
Fort Myers, Florida, United States, 33908
University of Florida Health Science Center - Gainesville Active, not recruiting
Gainesville, Florida, United States, 32610
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Suspended
Hollywood, Florida, United States, 33021
Nemours Children's Clinic-Jacksonville Suspended
Jacksonville, Florida, United States, 32207
University of Miami Miller School of Medicine-Sylvester Cancer Center Suspended
Miami, Florida, United States, 33136
Nicklaus Children's Hospital Suspended
Miami, Florida, United States, 33155
Miami Cancer Institute Suspended
Miami, Florida, United States, 33176
Florida Hospital Orlando Suspended
Orlando, Florida, United States, 32803
Arnold Palmer Hospital for Children Suspended
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Orlando Active, not recruiting
Orlando, Florida, United States, 32806
UF Cancer Center at Orlando Health Active, not recruiting
Orlando, Florida, United States, 32806
Nemours Children's Hospital Suspended
Orlando, Florida, United States, 32827
Nemours Children's Clinic - Pensacola Suspended
Pensacola, Florida, United States, 32504
Johns Hopkins All Children's Hospital Suspended
Saint Petersburg, Florida, United States, 33701
Saint Joseph's Hospital/Children's Hospital-Tampa Suspended
Tampa, Florida, United States, 33607
Saint Mary's Hospital Suspended
West Palm Beach, Florida, United States, 33407
United States, Georgia
Children's Healthcare of Atlanta - Egleston Suspended
Atlanta, Georgia, United States, 30322
Memorial Health University Medical Center Suspended
Savannah, Georgia, United States, 31404
United States, Hawaii
University of Hawaii Cancer Center Active, not recruiting
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children Suspended
Honolulu, Hawaii, United States, 96826
Tripler Army Medical Center Active, not recruiting
Honolulu, Hawaii, United States, 96859
United States, Idaho
Saint Luke's Mountain States Tumor Institute Suspended
Boise, Idaho, United States, 83712
United States, Illinois
Lurie Children's Hospital-Chicago Suspended
Chicago, Illinois, United States, 60611
University of Illinois Suspended
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center Suspended
Chicago, Illinois, United States, 60637
Loyola University Medical Center Suspended
Maywood, Illinois, United States, 60153
Advocate Children's Hospital-Oak Lawn Suspended
Oak Lawn, Illinois, United States, 60453
Advocate Children's Hospital-Park Ridge Suspended
Park Ridge, Illinois, United States, 60068
Advocate Lutheran General Hospital Active, not recruiting
Park Ridge, Illinois, United States, 60068
Saint Jude Midwest Affiliate Suspended
Peoria, Illinois, United States, 61637
Southern Illinois University School of Medicine Suspended
Springfield, Illinois, United States, 62702
United States, Indiana
Riley Hospital for Children Suspended
Indianapolis, Indiana, United States, 46202
Saint Vincent Hospital and Health Care Center Suspended
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital Suspended
Des Moines, Iowa, United States, 50309
University of Iowa/Holden Comprehensive Cancer Center Suspended
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky/Markey Cancer Center Suspended
Lexington, Kentucky, United States, 40536
Norton Children's Hospital Suspended
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Health Sciences Center Active, not recruiting
New Orleans, Louisiana, United States, 70112
Children's Hospital New Orleans Suspended
New Orleans, Louisiana, United States, 70118
Ochsner Medical Center Jefferson Suspended
New Orleans, Louisiana, United States, 70121
United States, Maine
Eastern Maine Medical Center Suspended
Bangor, Maine, United States, 04401
Maine Children's Cancer Program Suspended
Scarborough, Maine, United States, 04074
United States, Maryland
Sinai Hospital of Baltimore Suspended
Baltimore, Maryland, United States, 21215
Walter Reed National Military Medical Center Suspended
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Massachusetts General Hospital Cancer Center Suspended
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute Suspended
Boston, Massachusetts, United States, 02215
University of Massachusetts Medical School Suspended
Worcester, Massachusetts, United States, 01655
United States, Michigan
C S Mott Children's Hospital Suspended
Ann Arbor, Michigan, United States, 48109
Wayne State University/Karmanos Cancer Institute Suspended
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center Suspended
Detroit, Michigan, United States, 48236
Michigan State University Clinical Center Suspended
East Lansing, Michigan, United States, 48824-7016
Hurley Medical Center Active, not recruiting
Flint, Michigan, United States, 48503
Helen DeVos Children's Hospital at Spectrum Health Suspended
Grand Rapids, Michigan, United States, 49503
Bronson Methodist Hospital Suspended
Kalamazoo, Michigan, United States, 49007
Kalamazoo Center for Medical Studies Active, not recruiting
Kalamazoo, Michigan, United States, 49008
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Suspended
Minneapolis, Minnesota, United States, 55404
University of Minnesota/Masonic Cancer Center Suspended
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Suspended
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center Suspended
Jackson, Mississippi, United States, 39216
United States, Missouri
Columbia Regional Suspended
Columbia, Missouri, United States, 65201
University of Missouri - Ellis Fischel Withdrawn
Columbia, Missouri, United States, 65212
The Childrens Mercy Hospital Suspended
Kansas City, Missouri, United States, 64108
Washington University School of Medicine Suspended
Saint Louis, Missouri, United States, 63110
Mercy Hospital Saint Louis Suspended
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Children's Hospital and Medical Center of Omaha Suspended
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center Suspended
Omaha, Nebraska, United States, 68198
United States, Nevada
University Medical Center of Southern Nevada Suspended
Las Vegas, Nevada, United States, 89102
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
Children's Specialty Center of Nevada II Suspended
Las Vegas, Nevada, United States, 89109
Sunrise Hospital and Medical Center Suspended
Las Vegas, Nevada, United States, 89109
Summerlin Hospital Medical Center Suspended
Las Vegas, Nevada, United States, 89144
United States, New Hampshire
Dartmouth Hitchcock Medical Center Suspended
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center Suspended
Hackensack, New Jersey, United States, 07601
Morristown Medical Center Suspended
Morristown, New Jersey, United States, 07960
Saint Peter's University Hospital Suspended
New Brunswick, New Jersey, United States, 08901
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Suspended
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center Suspended
Newark, New Jersey, United States, 07112
Saint Joseph's Regional Medical Center Suspended
Paterson, New Jersey, United States, 07503
Overlook Hospital Active, not recruiting
Summit, New Jersey, United States, 07902
United States, New Mexico
University of New Mexico Cancer Center Suspended
Albuquerque, New Mexico, United States, 87102
United States, New York
Albany Medical Center Suspended
Albany, New York, United States, 12208
Montefiore Medical Center - Moses Campus Suspended
Bronx, New York, United States, 10467
Roswell Park Cancer Institute Suspended
Buffalo, New York, United States, 14263
NYU Winthrop Hospital Suspended
Mineola, New York, United States, 11501
The Steven and Alexandra Cohen Children's Medical Center of New York Suspended
New Hyde Park, New York, United States, 11040
Laura and Isaac Perlmutter Cancer Center at NYU Langone Suspended
New York, New York, United States, 10016
Mount Sinai Hospital Suspended
New York, New York, United States, 10029
Columbia University/Herbert Irving Cancer Center Suspended
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center Suspended
New York, New York, United States, 10065
University of Rochester Suspended
Rochester, New York, United States, 14642
State University of New York Upstate Medical University Suspended
Syracuse, New York, United States, 13210
New York Medical College Suspended
Valhalla, New York, United States, 10595
United States, North Carolina
Mission Hospital-Memorial Campus Suspended
Asheville, North Carolina, United States, 28801
UNC Lineberger Comprehensive Cancer Center Suspended
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center/Levine Cancer Institute Suspended
Charlotte, North Carolina, United States, 28203
Novant Health Presbyterian Medical Center Suspended
Charlotte, North Carolina, United States, 28204
Duke University Medical Center Suspended
Durham, North Carolina, United States, 27710
East Carolina University Suspended
Greenville, North Carolina, United States, 27858
Wake Forest University Health Sciences Suspended
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Children's Hospital Medical Center of Akron Suspended
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center Suspended
Cincinnati, Ohio, United States, 45229
Rainbow Babies and Childrens Hospital Suspended
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation Suspended
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital Suspended
Columbus, Ohio, United States, 43205
Dayton Children's Hospital Suspended
Dayton, Ohio, United States, 45404
Mercy Children's Hospital Suspended
Toledo, Ohio, United States, 43608
United States, Oklahoma
University of Oklahoma Health Sciences Center Suspended
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Emanuel Children's Hospital Suspended
Portland, Oregon, United States, 97227
Legacy Emanuel Hospital and Health Center Active, not recruiting
Portland, Oregon, United States, 97227
Oregon Health and Science University Suspended
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Children's Hospital Suspended
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Philadelphia Suspended
Philadelphia, Pennsylvania, United States, 19104
Saint Christopher's Hospital for Children Suspended
Philadelphia, Pennsylvania, United States, 19134
Children's Hospital of Pittsburgh of UPMC Suspended
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Rhode Island Hospital Suspended
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina Suspended
Charleston, South Carolina, United States, 29425
Palmetto Health Richland Suspended
Columbia, South Carolina, United States, 29203
BI-LO Charities Children's Cancer Center Suspended
Greenville, South Carolina, United States, 29605
Greenville Cancer Treatment Center Active, not recruiting
Greenville, South Carolina, United States, 29605
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Suspended
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
T C Thompson Children's Hospital Active, not recruiting
Chattanooga, Tennessee, United States, 37403
East Tennessee Childrens Hospital Suspended
Knoxville, Tennessee, United States, 37916
St. Jude Children's Research Hospital Suspended
Memphis, Tennessee, United States, 38105
The Children's Hospital at TriStar Centennial Suspended
Nashville, Tennessee, United States, 37203
Vanderbilt University/Ingram Cancer Center Suspended
Nashville, Tennessee, United States, 37232
United States, Texas
Dell Children's Medical Center of Central Texas Suspended
Austin, Texas, United States, 78723
Driscoll Children's Hospital Suspended
Corpus Christi, Texas, United States, 78411
Medical City Dallas Hospital Suspended
Dallas, Texas, United States, 75230
UT Southwestern/Simmons Cancer Center-Dallas Suspended
Dallas, Texas, United States, 75390
El Paso Children's Hospital Suspended
El Paso, Texas, United States, 79905
Brooke Army Medical Center Suspended
Fort Sam Houston, Texas, United States, 78234
Cook Children's Medical Center Suspended
Fort Worth, Texas, United States, 76104
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Suspended
Houston, Texas, United States, 77030
University Medical Center Suspended
Lubbock, Texas, United States, 79415
Children's Hospital of San Antonio Suspended
San Antonio, Texas, United States, 78207
Methodist Children's Hospital of South Texas Suspended
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio Suspended
San Antonio, Texas, United States, 78229
Scott and White Memorial Hospital Suspended
Temple, Texas, United States, 76508
United States, Utah
Primary Children's Hospital Suspended
Salt Lake City, Utah, United States, 84113
United States, Virginia
University of Virginia Cancer Center Suspended
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital Suspended
Falls Church, Virginia, United States, 22042
Childrens Hospital-King's Daughters Suspended
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University/Massey Cancer Center Suspended
Richmond, Virginia, United States, 23298
Carilion Clinic Children's Hospital Suspended
Roanoke, Virginia, United States, 24014
United States, Washington
Seattle Children's Hospital Suspended
Seattle, Washington, United States, 98105
Providence Sacred Heart Medical Center and Children's Hospital Suspended
Spokane, Washington, United States, 99204
Mary Bridge Children's Hospital and Health Center Suspended
Tacoma, Washington, United States, 98405
Madigan Army Medical Center Suspended
Tacoma, Washington, United States, 98431
United States, West Virginia
West Virginia University Charleston Suspended
Charleston, West Virginia, United States, 25304
West Virginia University Healthcare Suspended
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
University of Wisconsin Hospital and Clinics Active, not recruiting
Madison, Wisconsin, United States, 53792
Children's Hospital of Wisconsin Suspended
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
John Hunter Children's Hospital Suspended
Hunter Regional Mail Centre, New South Wales, Australia, 2310
The Children's Hospital at Westmead Suspended
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Women's and Children's Hospital-Adelaide Suspended
North Adelaide, South Australia, Australia, 5006
Australia, Western Australia
Princess Margaret Hospital for Children Suspended
Perth, Western Australia, Australia, 6008
Brazil
Instituto De Oncologia Pediatrica Suspended
Sao Paulo, Brazil, 04023-062
Canada, Alberta
Alberta Children's Hospital Suspended
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
British Columbia Children's Hospital Suspended
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba Suspended
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
IWK Health Centre Suspended
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Suspended
Hamilton, Ontario, Canada, L8N 3Z5
Kingston Health Sciences Centre Suspended
Kingston, Ontario, Canada, K7L 2V7
Children's Hospital of Eastern Ontario Suspended
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children Suspended
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
The Montreal Children's Hospital of the MUHC Suspended
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire Sainte-Justine Suspended
Montreal, Quebec, Canada, H3T 1C5
Canada, Saskatchewan
Saskatoon Cancer Centre Suspended
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
Centre Hospitalier Universitaire de Quebec Suspended
Quebec, Canada, G1V 4G2
Japan
Fukushima Medical University Hospital Suspended
Fukushima City, Fukushima Prefecture, Japan, 960-1295
Kagoshima University Medical Dental Hospital Suspended
Kagoshima City, Kagoshima, Japan, 890-8520
Shizuoka Cancer Center Suspended
Shizuoka City, Suntou, Japan, 411-8777
Nihon University Itabashi Hospital Suspended
Itabashi-ku, Tokyo, Japan, 173-8610
Hiroshima University Hospital Suspended
Hiroshima City, Japan, 734-8551
National Cancer Center Hospital Suspended
Tokyo, Japan, 104 0045
Puerto Rico
San Jorge Children's Hospital Suspended
San Juan, Puerto Rico, 00912
University Pediatric Hospital Suspended
San Juan, Puerto Rico, 00926
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Howard Katzenstein Children's Oncology Group

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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000654889
10-00098
AHEP0731
COG-AHEP0731
AHEP0731 ( Other Identifier: Childrens Oncology Group )
AHEP0731 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
UG1CA189958 ( U.S. NIH Grant/Contract )
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: November 2017

Additional relevant MeSH terms:
Hepatoblastoma
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Liver Extracts
Liposomal doxorubicin
Irinotecan
Cisplatin
Doxorubicin
Fluorouracil
Vincristine
Everolimus
Sirolimus
Camptothecin
Hematinics
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents