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

This study is currently recruiting participants.
Verified September 2017 by National Cancer Institute (NCI)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00980460
First Posted: September 21, 2009
Last Update Posted: October 18, 2017
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  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
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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disease status at the end of 2 courses of therapy [ Time Frame: Up to 42 days ]
  • 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.

  • 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.

  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 253
Actual Study Start Date: September 14, 2009
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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
  Contacts and Locations
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 Recruiting
Birmingham, Alabama, United States, 35233
Contact: Alyssa T. Reddy       helpdesk@childrensoncologygroup.org   
Principal Investigator: Alyssa T. Reddy         
University of Alabama at Birmingham Cancer Center Suspended
Birmingham, Alabama, United States, 35233
United States, Arizona
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Jessica Boklan    602-546-0920      
Principal Investigator: Jessica Boklan         
The University of Arizona Medical Center-University Campus 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 Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: David L. Becton    501-686-8274      
Principal Investigator: David L. Becton         
University of Arkansas for Medical Sciences Suspended
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 Recruiting
Loma Linda, California, United States, 92354
Contact: Albert Kheradpour    909-558-3375      
Principal Investigator: Albert Kheradpour         
Miller Children's and Women's Hospital Long Beach Recruiting
Long Beach, California, United States, 90806
Contact: Pamela H. Kempert       helpdesk@childrensoncologygroup.org   
Principal Investigator: Pamela H. Kempert         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas       helpdesk@childrensoncologygroup.org   
Principal Investigator: Leo Mascarenhas         
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 Central California Recruiting
Madera, California, United States, 93636-8762
Contact: Vonda L. Crouse       helpdesk@childrensoncologygroup.org   
Principal Investigator: Vonda L. Crouse         
Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609-1809
Contact: Carla B. Golden       helpdesk@childrensoncologygroup.org   
Principal Investigator: Carla B. Golden         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Steven K. Bergstrom    510-891-3400      
Principal Investigator: Steven K. Bergstrom         
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Elyssa M. Rubin       helpdesk@childrensoncologygroup.org   
Principal Investigator: Elyssa M. Rubin         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Sheri L. Spunt    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Sheri L. Spunt         
Sutter Medical Center Sacramento Recruiting
Sacramento, California, United States, 95816
Contact: Yung S. Yim    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Yung S. Yim         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Marcio H. Malogolowkin    916-734-3089      
Principal Investigator: Marcio H. Malogolowkin         
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: William D. Roberts       helpdesk@childrensoncologygroup.org   
Principal Investigator: William D. Roberts         
Naval Medical Center -San Diego Recruiting
San Diego, California, United States, 92134
Contact: Shelton A. Viola    619-532-8712      
Principal Investigator: Shelton A. Viola         
UCSF Medical Center-Parnassus Suspended
San Francisco, California, United States, 94143
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Robert E. Goldsby    877-827-3222      
Principal Investigator: Robert E. Goldsby         
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93102
Contact: Daniel J. Greenfield    805-682-7300      
Principal Investigator: Daniel J. Greenfield         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Brian S. Greffe       helpdesk@childrensoncologygroup.org   
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       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jennifer J. Clark         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michael S. Isakoff    800-579-7822      
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 Recruiting
Wilmington, Delaware, United States, 19803
Contact: Ramamoorthy Nagasubramanian       helpdesk@childrensoncologygroup.org   
Principal Investigator: Ramamoorthy Nagasubramanian         
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, D.C., District of Columbia, United States, 20007
Contact: Corina E. Gonzalez    202-444-2223      
Principal Investigator: Corina E. Gonzalez         
Children's National Medical Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Jeffrey S. Dome       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jeffrey S. Dome         
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         
Lee Memorial Health System Suspended
Fort Myers, Florida, United States, 33901
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Emad K. Salman    877-680-0008      
Principal Investigator: Emad K. Salman         
University of Florida Health Science Center �� Gainesville Suspended
Gainesville, Florida, United States, 32610
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Iftikhar Hanif       helpdesk@childrensoncologygroup.org   
Principal Investigator: Iftikhar Hanif         
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Ramamoorthy Nagasubramanian       helpdesk@childrensoncologygroup.org   
Principal Investigator: Ramamoorthy Nagasubramanian         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Julio C. Barredo    305-243-2647      
Principal Investigator: Julio C. Barredo         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Enrique A. Escalon       helpdesk@childrensoncologygroup.org   
Principal Investigator: Enrique A. Escalon         
Baptist Hospital of Miami Recruiting
Miami, Florida, United States, 33176
Contact: Doured Daghistani    800-599-2456    cancerinfo@baptisthealth.net   
Principal Investigator: Doured Daghistani         
Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Fouad M. Hajjar    407-303-2090    FH.Cancer.Research@flhosp.org   
Principal Investigator: Fouad M. Hajjar         
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         
Nemours Children's Clinic - Orlando Suspended
Orlando, Florida, United States, 32806
UF Cancer Center at Orlando Health Suspended
Orlando, Florida, United States, 32806
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Ramamoorthy Nagasubramanian       helpdesk@childrensoncologygroup.org   
Principal Investigator: Ramamoorthy Nagasubramanian         
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Ramamoorthy Nagasubramanian       helpdesk@childrensoncologygroup.org   
Principal Investigator: Ramamoorthy Nagasubramanian         
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Jennifer L. Mayer    212-639-7202      
Principal Investigator: Jennifer L. Mayer         
Saint Joseph's Hospital/Children's Hospital-Tampa Recruiting
Tampa, Florida, United States, 33607
Contact: Mark J. Mogul    704-384-5369      
Principal Investigator: Mark J. Mogul         
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda       helpdesk@childrensoncologygroup.org   
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Muna Qayed       helpdesk@childrensoncologygroup.org   
Principal Investigator: Muna Qayed         
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
University of Hawaii Cancer Center Suspended
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Wade T. Kyono    808-586-2979      
Principal Investigator: Wade T. Kyono         
Tripler Army Medical Center Suspended
Honolulu, Hawaii, United States, 96859
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Eugenia Chang       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eugenia Chang         
United States, Illinois
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Yasmin C. Gosiengfiao       helpdesk@childrensoncologygroup.org   
Principal Investigator: Yasmin C. Gosiengfiao         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary L. Schmidt    312-355-3046      
Principal Investigator: Mary L. Schmidt         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Susan L. Cohn    773-834-7424      
Principal Investigator: Susan L. Cohn         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Eugene Suh    708-226-4357      
Principal Investigator: Eugene Suh         
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Rebecca E. McFall       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rebecca E. McFall         
Advocate Children's Hospital-Park Ridge Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Rebecca E. McFall       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rebecca E. McFall         
Advocate Lutheran General Hospital Suspended
Park Ridge, Illinois, United States, 60068
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Pedro A. De Alarcon    888-226-4343      
Principal Investigator: Pedro A. De Alarcon         
Southern Illinois University School of Medicine 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: Kamnesh R. Pradhan    800-248-1199      
Principal Investigator: Kamnesh R. Pradhan         
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Bassem I. Razzouk    317-338-2194    research@stvincent.org   
Principal Investigator: Bassem I. Razzouk         
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Wendy L. Woods-Swafford    515-241-3305    rbehrens@cancercenterofiowa.com   
Principal Investigator: Wendy L. Woods-Swafford         
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mariko Sato    800-237-1225      
Principal Investigator: Mariko Sato         
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Lars M. Wagner    859-257-3379      
Principal Investigator: Lars M. Wagner         
Norton Children's Hospital Suspended
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Health Sciences Center Suspended
New Orleans, Louisiana, United States, 70112
Children's Hospital New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Lolie C. Yu       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lolie C. Yu         
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Craig Lotterman    504-842-3708      
Principal Investigator: Craig Lotterman         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Sam W. Lew    207-973-4274      
Principal Investigator: Sam W. Lew         
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: Jason M. Fixler    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Jason M. Fixler         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Anne B. Warwick    619-532-8712      
Principal Investigator: Anne B. Warwick         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alison M. Friedmann    877-726-5130      
Principal Investigator: Alison M. Friedmann         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Suzanne Shusterman    877-442-3324      
Principal Investigator: Suzanne Shusterman         
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Christopher P. Keuker    508-856-6265      
Principal Investigator: Christopher P. Keuker         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Rama Jasty       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rama Jasty         
Wayne State University/Karmanos Cancer Institute Suspended
Detroit, Michigan, United States, 48201
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 Recruiting
Flint, Michigan, United States, 48502
Contact: Nkechi Onwuzurike    810-762-8057      
Principal Investigator: Nkechi Onwuzurike         
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: David S. Dickens    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: David S. Dickens         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Katharina E. Elliott    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Katharina E. Elliott         
Kalamazoo Center for Medical Studies Suspended
Kalamazoo, Michigan, United States, 49008
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Michael K. Richards       helpdesk@childrensoncologygroup.org   
Principal Investigator: Michael K. Richards         
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Brenda J. Weigel       helpdesk@childrensoncologygroup.org   
Principal Investigator: Brenda J. Weigel         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Carola A. Arndt    855-776-0015      
Principal Investigator: Carola A. Arndt         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Gail C. Megason    601-815-6700      
Principal Investigator: Gail C. Megason         
United States, Missouri
Columbia Regional Recruiting
Columbia, Missouri, United States, 65201
Contact: Barbara A. Gruner       helpdesk@childrensoncologygroup.org   
Principal Investigator: Barbara A. Gruner         
University of Missouri - Ellis Fischel Withdrawn
Columbia, Missouri, United States, 65212
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Keith J. August       helpdesk@childrensoncologygroup.org   
Principal Investigator: Keith J. August         
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         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Bethany G. Sleckman         
United States, Nebraska
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Minnie Abromowitch       helpdesk@childrensoncologygroup.org   
Principal Investigator: Minnie Abromowitch         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Minnie Abromowitch       helpdesk@childrensoncologygroup.org   
Principal Investigator: Minnie Abromowitch         
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
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 Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
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 Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Steven L. Halpern    201-996-2879      
Principal Investigator: Steven L. Halpern         
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Nibal A. Zaghloul       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nibal A. Zaghloul         
Rutgers Cancer Institute of New Jersey-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 Recruiting
Newark, New Jersey, United States, 07112
Contact: Peri Kamalakar    973-926-7230      
Principal Investigator: Peri Kamalakar         
Saint Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary A. Bonilla       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mary A. Bonilla         
Overlook Hospital Suspended
Summit, New Jersey, United States, 07902
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Koh B. Boayue    505-925-0366    LByatt@nmcca.org   
Principal Investigator: Koh B. Boayue         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Vikramjit S. Kanwar    518-262-3368      
Principal Investigator: Vikramjit S. Kanwar         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Denise A. Rokitka    877-275-7724      
Principal Investigator: Denise A. Rokitka         
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mark E. Weinblatt    516-663-3115      
Principal Investigator: Mark E. Weinblatt         
The Steven and Alexandra Cohen Children's Medical Center of New York Recruiting
New Hyde Park, New York, United States, 11040
Contact: Carolyn F. Levy       helpdesk@childrensoncologygroup.org   
Principal Investigator: Carolyn F. Levy         
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Sharon L. Gardner    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Sharon L. Gardner         
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Birte Wistinghausen    212-824-7309    CCTO@mssm.edu   
Principal Investigator: Birte Wistinghausen         
Columbia University/Herbert Irving Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Alice Lee    212-305-8615      
Principal Investigator: Alice Lee         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Peter G. Steinherz    212-639-7202      
Principal Investigator: Peter G. Steinherz         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Jeffrey R. Andolina    585-275-5830      
Principal Investigator: Jeffrey R. Andolina         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Philip M. Monteleone    315-464-5476      
Principal Investigator: Philip M. Monteleone         
Montefiore Medical Center - Moses Campus Suspended
The Bronx, New York, United States, 10467-2490
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Jessica C. Hochberg    914-594-3794      
Principal Investigator: Jessica C. Hochberg         
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         
UNC Lineberger Comprehensive Cancer Center 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/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Joel A. Kaplan    704-355-2884      
Principal Investigator: Joel A. Kaplan         
Novant Health Presbyterian Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Jessica A. Bell    704-384-5369      
Principal Investigator: Jessica A. Bell         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Susan G. Kreissman    888-275-3853      
Principal Investigator: Susan G. Kreissman         
East Carolina University Recruiting
Greenville, North Carolina, United States, 27858
Contact: Beng R. Fuh    252-744-2391      
Principal Investigator: Beng R. Fuh         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Thomas B. Russell    336-713-6771      
Principal Investigator: Thomas B. Russell         
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Steven J. Kuerbitz       helpdesk@childrensoncologygroup.org   
Principal Investigator: Steven J. Kuerbitz         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: James I. Geller       helpdesk@childrensoncologygroup.org   
Principal Investigator: James I. Geller         
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         
Cleveland Clinic Foundation Suspended
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark A. Ranalli       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Ayman A. El-Sheikh       helpdesk@childrensoncologygroup.org   
Principal Investigator: Ayman A. El-Sheikh         
Mercy Children's Hospital Suspended
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    405-271-8777    ou-clinical-trials@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    503-413-8199      
Principal Investigator: Janice F. Olson         
Legacy Emanuel Hospital and Health Center Suspended
Portland, Oregon, United States, 97227
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Suman Malempati    503-494-1080    trials@ohsu.edu   
Principal Investigator: Suman Malempati         
United States, Pennsylvania
Penn State Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Lisa M. McGregor       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lisa M. McGregor         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elizabeth Fox    800-411-1222      
Principal Investigator: Elizabeth Fox         
Saint Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Gregory E. Halligan       helpdesk@childrensoncologygroup.org   
Principal Investigator: Gregory E. Halligan         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Arthur K. Ritchey       helpdesk@childrensoncologygroup.org   
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
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jacqueline M. Kraveka    843-792-9321      
Principal Investigator: Jacqueline M. Kraveka         
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Stuart L. Cramer    803-434-3680      
Principal Investigator: Stuart L. Cramer         
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Nichole L. Bryant       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nichole L. Bryant         
Greenville Cancer Treatment Center Suspended
Greenville, South Carolina, United States, 29605
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Kayelyn J. Wagner    605-328-1367      
Principal Investigator: Kayelyn J. Wagner         
United States, Tennessee
T C Thompson Children's Hospital Suspended
Chattanooga, Tennessee, United States, 37403
East Tennessee Childrens Hospital Suspended
Knoxville, Tennessee, United States, 37916
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Wayne L. Furman       helpdesk@childrensoncologygroup.org   
Principal Investigator: Wayne L. Furman         
The Children's Hospital at TriStar Centennial Recruiting
Nashville, Tennessee, United States, 37203
Contact: Haydar A. Frangoul    800-811-8480      
Principal Investigator: Haydar A. Frangoul         
Vanderbilt University/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: Amy C. Fowler       helpdesk@childrensoncologygroup.org   
Principal Investigator: Amy C. Fowler         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Nkechi I. Mba       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nkechi I. Mba         
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Stanton C. Goldman    972-566-5588      
Principal Investigator: Stanton C. Goldman         
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Jonathan E. Wickiser    214-648-7097      
Principal Investigator: Jonathan E. Wickiser         
El Paso Children's Hospital Recruiting
El Paso, Texas, United States, 79905
Contact: Lisa L. Hartman       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lisa L. Hartman         
Brooke Army Medical Center Suspended
Fort Sam Houston, Texas, United States, 78234
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Lauren J. Akers       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lauren J. Akers         
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Patrick A. Thompson    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Patrick A. Thompson         
University Medical Center Recruiting
Lubbock, Texas, United States, 79415
Contact: Mohamad M. Al-Rahawan    309-655-3258      
Principal Investigator: Mohamad M. Al-Rahawan         
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: Vinod K. Gidvani-Diaz       helpdesk@childrensoncologygroup.org   
Principal Investigator: Vinod K. Gidvani-Diaz         
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 Recruiting
Temple, Texas, United States, 76508
Contact: Guy H. Grayson    254-724-5407      
Principal Investigator: Guy H. Grayson         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Phillip E. Barnette       helpdesk@childrensoncologygroup.org   
Principal Investigator: Phillip E. Barnette         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: William C. Petersen    434-243-6322    JME3D@hscmail.mcc.virginia.edu   
Principal Investigator: William C. Petersen         
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Marshall A. Schorin    703-208-6650    Stephanie.VanBebber@inova.org   
Principal Investigator: Marshall A. Schorin         
Childrens Hospital-King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Eric J. Lowe       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eric J. Lowe         
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Gita V. Massey       helpdesk@childrensoncologygroup.org   
Principal Investigator: Gita V. Massey         
Carilion Clinic Children's Hospital Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mandy M. Atkinson       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mandy M. Atkinson         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas S. Hawkins       helpdesk@childrensoncologygroup.org   
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Judy L. Felgenhauer       helpdesk@childrensoncologygroup.org   
Principal Investigator: Judy L. Felgenhauer         
Mary Bridge Children's Hospital and Health Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Robert G. Irwin       helpdesk@childrensoncologygroup.org   
Principal Investigator: Robert G. Irwin         
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Melissa A. Forouhar    301-319-2100      
Principal Investigator: Melissa A. Forouhar         
United States, West Virginia
West Virginia University Charleston Recruiting
Charleston, West Virginia, United States, 25304
Contact: Ashley E. Meyer    304-388-9944      
Principal Investigator: Ashley E. Meyer         
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Stephan R. Paul    304-293-7374    cancertrialsinfo@hsc.wvu.edu   
Principal Investigator: Stephan R. Paul         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Kenneth B. De Santes    800-622-8922      
Principal Investigator: Kenneth B. De Santes         
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Paul D. Harker-Murray    214-648-7097      
Principal Investigator: Paul D. Harker-Murray         
Australia, New South Wales
John Hunter Children's Hospital Recruiting
Hunter Regional Mail Centre, New South Wales, Australia, 2310
Contact: Geoffrey B. McCowage    (02) 9845 8183      
Principal Investigator: Geoffrey B. McCowage         
The Children's Hospital at Westmead Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Geoffrey B. McCowage    (02) 9845 8183      
Principal Investigator: Geoffrey B. McCowage         
Australia, South Australia
Women's and Children's Hospital-Adelaide Recruiting
North Adelaide, South Australia, Australia, 5006
Contact: Maria L. Kirby       helpdesk@childrensoncologygroup.org   
Principal Investigator: Maria L. Kirby         
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6008
Contact: Marianne B. Phillips    (08) 9340 8222    catherine.cole@health.wa.gov.au   
Principal Investigator: Marianne B. Phillips         
Brazil
Instituto De Oncologia Pediatrica Suspended
Sao Paulo, Brazil, 04023-062
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Douglas R. Strother       helpdesk@childrensoncologygroup.org   
Principal Investigator: Douglas R. Strother         
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: David B. Dix       helpdesk@childrensoncologygroup.org   
Principal Investigator: David B. Dix         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Tanya R. Brown    306-766-2213      
Principal Investigator: Tanya R. Brown         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Conrad V. Fernandez    902-470-8394      
Principal Investigator: Conrad V. Fernandez         
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine       helpdesk@childrensoncologygroup.org   
Principal Investigator: Carol Portwine         
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Mariana P. Silva    613-544-2630      
Principal Investigator: Mariana P. Silva         
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Donna L. Johnston       helpdesk@childrensoncologygroup.org   
Principal Investigator: Donna L. Johnston         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Meredith S. Irwin    416-813-7654 ext 2027    jason.mcguire@sickkids.ca   
Principal Investigator: Meredith S. Irwin         
Canada, Quebec
The Montreal Children's Hospital of the MUHC Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon B. Abish       helpdesk@childrensoncologygroup.org   
Principal Investigator: Sharon B. Abish         
Centre Hospitalier Universitaire Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson    514-345-4931      
Principal Investigator: Yvan Samson         
Canada, Saskatchewan
Saskatoon Cancer Centre Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Christopher Mpofu    306-655-2914      
Principal Investigator: Christopher Mpofu         
Canada
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Bruno Michon       helpdesk@childrensoncologygroup.org   
Principal Investigator: Bruno Michon         
Japan
Fukushima Medical University Hospital Recruiting
Fukushima City, Fukushima Prefecture, Japan, 960-1295
Contact: Atsushi Kikuta    813 5791 6398    global@insti.kitasato-u.ac.jp   
Principal Investigator: Atsushi Kikuta         
Kagoshima University Medical Dental Hospital Recruiting
Kagoshima City, Kagoshima, Japan, 890-8520
Contact: Yasuhiro Okamoto    81-99-275-5111      
Principal Investigator: Yasuhiro Okamoto         
Shizuoka Cancer Center Recruiting
Shizuoka City, Suntou, Japan, 411-8777
Contact: Yuji Ishida    81-55-989-5222      
Principal Investigator: Yuji Ishida         
Nihon University Itabashi Hospital Recruiting
Itabashi-ku, Tokyo, Japan, 173-8610
Contact: Tsugumichi Koshinaga    03-3972-8111      
Principal Investigator: Tsugumichi Koshinaga         
Hiroshima University Hospital Recruiting
Hiroshima City, Japan, 734-8551
Contact: Eiso Hiyama    81-3-3542-2511    www-admin@ncc.go.jp   
Principal Investigator: Eiso Hiyama         
National Cancer Center Hospital Recruiting
Tokyo, Japan, 104 0045
Contact: Chitose Ogawa    81-3-3542-2511    www-admin@ncc.go.jp   
Principal Investigator: Chitose Ogawa         
Puerto Rico
San Jorge Children's Hospital Recruiting
San Juan, Puerto Rico, 00912
Contact: Luis A. Clavell       helpdesk@childrensoncologygroup.org   
Principal Investigator: Luis A. Clavell         
University Pediatric Hospital Recruiting
San Juan, Puerto Rico, 00926
Contact: Luis A. Clavell       helpdesk@childrensoncologygroup.org   
Principal Investigator: Luis A. Clavell         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Howard Katzenstein Children's Oncology Group
  More Information

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
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 Submitted: September 18, 2009
First Posted: September 21, 2009
Last Update Posted: October 18, 2017
Last Verified: September 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