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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00980460
First received: September 18, 2009
Last updated: June 30, 2016
Last verified: April 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disease status at the end of 2 courses of therapy [ Time Frame: Up to 42 days ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: Time from patient enrollment to progression, treatment failure, death from any cause, diagnosis of a second malignant neoplasm, or last follow-up, assessed up to 7 years ] [ Designated as safety issue: No ]
    Estimated by the method of Kaplan and Meier.

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

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


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


Estimated Enrollment: 253
Study Start Date: September 2009
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be newly diagnosed with histologically-proven hepatoblastoma
  • In emergency situations when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled on AHEP0731 without a biopsy

    • Clinical situations in which such emergent treatment may be indicated include, but are not limited to, the following circumstances:

      • Anatomic or mechanical compromise of critical organ function by tumor (eg, respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc)
      • Uncorrectable coagulopathy
    • For a patient to maintain eligibility for AHEP0731 when emergent treatment is given, the following must occur:

      • The patient must have a clinical diagnosis of hepatoblastoma, including an elevated alpha fetoprotein, and must meet all AHEP0731 eligibility criteria at the time of emergent treatment
      • Patient must be enrolled on AHEP0731 prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP0731 enrollment
      • If the patient receives AHEP0731 chemotherapy PRIOR to undergoing a diagnostic biopsy, pathologic review of material obtained in the future during either biopsy or surgical resection must either confirm the diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be included in the analysis of the study aims
  • Patients will be staged for risk classification and treatment at diagnosis using Children's Oncology Group (COG) staging guidelines
  • At the time of study enrollment, the patient's treatment regimen must be identified; if the patient's primary tumor was resected prior to the day of enrollment and a blood specimen for the determination of serum alpha fetoprotein was not obtained prior to that surgery, the patient will be considered to have alpha fetoprotein of greater than 100 ng/mL for the purpose of treatment assignment; if tumor samples obtained prior to the date of enrollment were not sufficient to determine whether small cell undifferentiated (SCU) histology was present, treatment assignment will be made assuming SCU is not present in the tumor
  • For patients with stage I or II disease, specimens for rapid central review have been submitted and the rapid central review diagnosis and staging must be available to be provided on the AHEP0731 eligibility case report form (CRF)
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Alyssa T. Reddy    205-638-9285    areddy@peds.uab.edu   
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    jboklan@phoenixchildrens.com   
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    lkopp@peds.arizona.edu   
Principal Investigator: Lisa M. Kopp         
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: David L. Becton    501-364-7373      
Principal Investigator: David L. Becton         
University of Arkansas for Medical Sciences Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90242
Contact: Robert M. Cooper    626-564-3455    robert.m.cooper@kp.org   
Principal Investigator: Robert M. Cooper         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Albert Kheradpour       unknown@example.com   
Principal Investigator: Albert Kheradpour         
Miller Children's and Women's Hospital Long Beach Recruiting
Long Beach, California, United States, 90806
Contact: Pamela H. Kempert    562-933-5600    pkempert@memorialcare.org   
Principal Investigator: Pamela H. Kempert         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas    323-361-4110    lmascarenhas@chla.usc.edu   
Principal Investigator: Leo Mascarenhas         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Fataneh (Fae) Majlessipour    310-423-8965    majlessipour@cshs.org   
Principal Investigator: Fataneh (Fae) Majlessipour         
Children's Hospital Central California Recruiting
Madera, California, United States, 93636-8762
Contact: Vonda L. Crouse    866-353-5437    vcrouse@valleychildrens.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    510-450-7600    cgolden@mail.cho.org   
Principal Investigator: Carla B. Golden         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Steven K. Bergstrom    626-564-3455    steven.k.bergstrom@kp.org   
Principal Investigator: Steven K. Bergstrom         
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Violet Shen    714-997-3000    vshen@choc.org   
Principal Investigator: Violet Shen         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Neyssa M. Marina    650-498-7061    clinicaltrials@med.stanford.edu   
Principal Investigator: Neyssa M. Marina         
Sutter General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Yung S. Yim    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Yung S. Yim         
University of California Davis Comprehensive Cancer Center Suspended
Sacramento, California, United States, 95817
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: William D. Roberts    858-966-5934    wroberts@rchsd.org   
Principal Investigator: William D. Roberts         
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    goldsbyr@ucsf.edu   
Principal Investigator: Robert E. Goldsby         
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93102
Contact: Daniel J. Greenfield    805-682-7300    dgreenfield@sbch.org   
Principal Investigator: Daniel J. Greenfield         
United States, Colorado
Children's Hospital Colorado Suspended
Aurora, Colorado, United States, 80045
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Jennifer J. Clark    866-775-6246    jennifer.clark5@hcahealthcare.com   
Principal Investigator: Jennifer J. Clark         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michael S. Isakoff    860-545-9981    misakoff@connecticutchildrens.org   
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Nina S. Kadan-Lottick    203-785-5702    nina.kadan-lottick@yale.edu   
Principal Investigator: Nina S. Kadan-Lottick         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Ramamoorthy Nagasubramanian    407-650-7150    rnagasub@nemours.org   
Principal Investigator: Ramamoorthy Nagasubramanian         
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Aziza T. Shad    202-444-0381    shada@georgetown.edu   
Principal Investigator: Aziza T. Shad         
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jeffrey S. Dome    202-884-2549    jdome@childrensnational.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    hrodriguez-cort@browardhealth.org   
Principal Investigator: Hector M. Rodriguez-Cortes         
Lee Memorial Health System Withdrawn
Fort Myers, Florida, United States, 33901
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Emad K. Salman    239-343-5333    emad.salman@leememorial.org   
Principal Investigator: Emad K. Salman         
University of Florida Active, not recruiting
Gainesville, Florida, United States, 32610
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Iftikhar Hanif    954-265-2234    ihanif@mhs.net   
Principal Investigator: Iftikhar Hanif         
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Ramamoorthy Nagasubramanian    407-650-7150    rnagasub@nemours.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    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Julio C. Barredo         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Enrique A. Escalon    888-624-2778    enrique.escalon@mch.com   
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    407-303-5623    fouad.hajjar.md@flhosp.org   
Principal Investigator: Fouad M. Hajjar         
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti    321-841-7743    vincent.giusti@orlandohealth.com   
Principal Investigator: Vincent F. Giusti         
Nemours Children's Clinic - Orlando Withdrawn
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    407-650-7150    rnagasub@nemours.org   
Principal Investigator: Ramamoorthy Nagasubramanian         
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Ramamoorthy Nagasubramanian    407-650-7150    rnagasub@nemours.org   
Principal Investigator: Ramamoorthy Nagasubramanian         
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Gregory A. Hale    727-767-4176    ghale4@jhmi.edu   
Principal Investigator: Gregory A. Hale         
Saint Joseph's Hospital/Children's Hospital-Tampa Recruiting
Tampa, Florida, United States, 33607
Contact: Dana A. Obzut    800-882-4123      
Principal Investigator: Dana A. Obzut         
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Glen Lew    404-785-1112      
Principal Investigator: Glen Lew         
Memorial University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: J. M. Johnston    912-350-8568    martinjohnston@memorialhealth.com   
Principal Investigator: J. M. Johnston         
United States, Hawaii
University of Hawaii Cancer Center Withdrawn
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Wade T. Kyono    808-983-6090    kyono@hawaii.edu   
Principal Investigator: Wade T. Kyono         
Tripler Army Medical Center Terminated
Honolulu, Hawaii, United States, 96859
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Eugenia Chang    800-845-4624      
Principal Investigator: Eugenia Chang         
United States, Illinois
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Yasmin C. Gosiengfiao    773-880-4562    ygosiengfiao@luriechildrens.org   
Principal Investigator: Yasmin C. Gosiengfiao         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary L. Schmidt    312-355-3046    mls3@uic.edu   
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    esuh@lumc.edu   
Principal Investigator: Eugene Suh         
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Rebecca E. McFall    847-723-7570    rebecca.mcfall@advocatehealth.com   
Principal Investigator: Rebecca E. McFall         
Advocate Children's Hospital-Park Ridge Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Jong-Hyo Kwon    847-384-3621    jong-hyo.kwon@advocatehealth.com   
Principal Investigator: Jong-Hyo Kwon         
Advocate Lutheran General Hospital Withdrawn
Park Ridge, Illinois, United States, 60068
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Karen S. Fernandez    309-655-3258      
Principal Investigator: Karen S. Fernandez         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Gregory P. Brandt    217-545-7929    gbrandt@siumed.edu   
Principal Investigator: Gregory P. Brandt         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robert J. Fallon    317-944-8784    rfallon@iupui.edu   
Principal Investigator: Robert J. Fallon         
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    515-241-6729    wendy.woods-swafford@unitypoint.org   
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    lars.wagner@uky.edu   
Principal Investigator: Lars M. Wagner         
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kenneth G. Lucas    866-530-5516      
Principal Investigator: Kenneth G. Lucas         
United States, Louisiana
Tulane University Health Sciences Center Withdrawn
New Orleans, Louisiana, United States, 70112
Children's Hospital New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Lolie C. Yu    504-894-5377    lyu@lsuhsc.edu   
Principal Investigator: Lolie C. Yu         
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Craig Lotterman    888-562-4763    clotterman@ochsner.org   
Principal Investigator: Craig Lotterman         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Sam W. Lew    800-987-3005    slew@emhs.org   
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: Joseph M. Wiley    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Joseph M. Wiley         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Anne B. Warwick    301-400-1662    anne.warwick@usuhs.edu   
Principal Investigator: Anne B. Warwick         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Active, not recruiting
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Carlos Rodriguez-Galindo    877-442-3324      
Principal Investigator: Carlos Rodriguez-Galindo         
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Christopher P. Keuker    508-856-3216    cancer.research@umassmed.edu   
Principal Investigator: Christopher P. Keuker         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Rama Jasty    800-865-1125    rjasty@med.umich.edu   
Principal Investigator: Rama Jasty         
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Jeffrey W. Taub    313-576-9363      
Principal Investigator: Jeffrey W. Taub         
Michigan State University Clinical Center Recruiting
East Lansing, Michigan, United States, 48824-7016
Contact: Renuka Gera    517-975-9547    renuka.gera@hc.msu.edu   
Principal Investigator: Renuka Gera         
Hurley Medical Center Suspended
Flint, Michigan, United States, 48502
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: David S. Dickens    616-267-1925    David.Dickens@helendevoschildrens.org   
Principal Investigator: David S. Dickens         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Katharina E. Elliott    800-227-2345    elliottk@bronsonhg.org   
Principal Investigator: Katharina E. Elliott         
Kalamazoo Center for Medical Studies Recruiting
Kalamazoo, Michigan, United States, 49008
Contact: Jeffrey S. Lobel    800-227-2345      
Principal Investigator: Jeffrey S. Lobel         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Michael K. Richards    612-813-5193      
Principal Investigator: Michael K. Richards         
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Brenda J. Weigel    612-624-2620    weige007@umn.edu   
Principal Investigator: Brenda J. Weigel         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Carola A. Arndt    507-538-7623    carndt@mayo.edu   
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: Thomas W. Loew    573-884-4277    loewt@health.missouri.edu   
Principal Investigator: Thomas W. Loew         
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    816-234-3265    kjaugust@cmh.edu   
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    913-948-5588    Bethany.Sleckman@Mercy.Net   
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    402-955-3949    mabromowitch@childrensomaha.org   
Principal Investigator: Minnie Abromowitch         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Minnie Abromowitch    402-955-3949    mabromowitch@childrensomaha.org   
Principal Investigator: Minnie Abromowitch         
United States, Nevada
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    aikeda@cure4thekids.org   
Principal Investigator: Alan K. Ikeda         
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Alan K. Ikeda    702-384-0013    aikeda@cure4thekids.org   
Principal Investigator: Alan K. Ikeda         
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Alan K. Ikeda    702-384-0013    aikeda@cure4thekids.org   
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    mbharris@hackensackumc.org   
Principal Investigator: Michael B. Harris         
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Steven L. Halpern    973-971-5900    steven.halpern@atlantichealth.org   
Principal Investigator: Steven L. Halpern         
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Nibal A. Zaghloul    732-745-8600 ext 6163    kcovert@saintpetersuh.com   
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    drachtri@cinj.rutgers.edu   
Principal Investigator: Richard A. Drachtman         
Newark Beth Israel Medical Center Active, not recruiting
Newark, New Jersey, United States, 07112
Saint Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary A. Bonilla    973-754-2909    bonillam@sjhmc.org   
Principal Investigator: Mary A. Bonilla         
Overlook Hospital Recruiting
Summit, New Jersey, United States, 07902
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Koh B. Boayue    505-272-6972    kboayue@salud.unm.edu   
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    kanwarv@mail.amc.edu   
Principal Investigator: Vikramjit S. Kanwar         
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467-2490
Contact: Jonathan B. Gill    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Jonathan B. Gill         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Denise A. Rokitka    716-845-8003    denise.rokitka@roswellpark.org   
Principal Investigator: Denise A. Rokitka         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mark E. Weinblatt    866-946-8476    mweinbla@winthrop.org   
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    718-343-4642    clevy4@nshs.edu   
Principal Investigator: Carolyn F. Levy         
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Linda Granowetter    212-263-8410    prmc.coordinator@nyumc.org   
Principal Investigator: Linda Granowetter         
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Birte Wistinghausen    212-824-7320    jenny.figueroa@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    al2041@cumc.columbia.edu   
Principal Investigator: Alice Lee         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Peter G. Steinherz    212-639-7202    steinhep@mskcc.org   
Principal Investigator: Peter G. Steinherz         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Jeffrey R. Andolina    585-275-5830    jeffrey_andolina@urmc.rochester.edu   
Principal Investigator: Jeffrey R. Andolina         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Karol H. Kerr    315-464-5476    kerrk@upstate.edu   
Principal Investigator: Karol H. Kerr         
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Jessica C. Hochberg    914-594-3794    jessica_hochberg@nymc.edu   
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    douglas.scothorn@msj.org   
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: Paulette C. Bryant    704-384-5369      
Principal Investigator: Paulette C. Bryant         
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: George E. Hucks    252-744-2391      
Principal Investigator: George E. Hucks         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Thomas B. Russell    336-713-6771    trussell@wakehealth.edu   
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    330-543-3193    skuerbitz@chmca.org   
Principal Investigator: Steven J. Kuerbitz         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: James I. Geller    513-636-2799    james.geller@cchmc.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    yousif.matloub@uhhospitals.org   
Principal Investigator: Yousif (Joe) H. Matloub         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Margaret C. Thompson    866-223-8100    thompsm12@ccf.org   
Principal Investigator: Margaret C. Thompson         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark A. Ranalli    614-722-2708    mark.ranalli@nationwidechildrens.org   
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Ayman A. El-Sheikh    800-228-4055    elsheikha@childrensdayton.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    503-413-2560    jfolson@lhs.org   
Principal Investigator: Janice F. Olson         
Legacy Emanuel Hospital and Health Center Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-2560      
Principal Investigator: Janice F. Olson         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Linda C. Stork    503-494-1080    trials@ohsu.edu   
Principal Investigator: Linda C. Stork         
United States, Pennsylvania
Penn State Hershey Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Lisa M. McGregor    717-531-6012    lmcgregor@hmc.psu.edu   
Principal Investigator: Lisa M. McGregor         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elizabeth Fox    215-590-2810    foxe@email.chop.edu   
Principal Investigator: Elizabeth Fox         
Saint Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Akash Nahar    215-427-8991      
Principal Investigator: Akash Nahar         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Arthur K. Ritchey    412-692-5573    kim.ritchey@chp.edu   
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    jwelch@lifespan.org   
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    kravekjm@musc.edu   
Principal Investigator: Jacqueline M. Kraveka         
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Ronnie W. Neuberg    803-434-3680    ronnie.neuberg@palmettohealth.org   
Principal Investigator: Ronnie W. Neuberg         
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Nichole L. Bryant    864-241-6251    nbryant@ghs.org   
Principal Investigator: Nichole L. Bryant         
Greenville Cancer Treatment Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Cary E. Stroud    864-241-6251      
Principal Investigator: Cary E. Stroud         
United States, Tennessee
T C Thompson Children's Hospital Suspended
Chattanooga, Tennessee, United States, 37403
East Tennessee Childrens Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Ray C. Pais    865-541-8553    raycpais@knology.net   
Principal Investigator: Ray C. Pais         
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Wayne L. Furman    866-278-5833    info@stjude.org   
Principal Investigator: Wayne L. Furman         
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Scott C. Borinstein    800-811-8480    scott.c.borinstein@vanderbilt.edu   
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    214-648-7097    acFowler@seton.org   
Principal Investigator: Amy C. Fowler         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: M. C. Johnson    361-694-5311    cris.johnson@dchstx.org   
Principal Investigator: M. C. Johnson         
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    jonathan.wickiser@utsouthwestern.edu   
Principal Investigator: Jonathan E. Wickiser         
El Paso Children's Hospital Recruiting
El Paso, Texas, United States, 79905
Contact: Lisa L. Hartman    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Lisa L. Hartman         
Brooke Army Medical Center Terminated
Fort Sam Houston, Texas, United States, 78234
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Lauren J. Akers    682-885-2103    lauren.akers@cookchildrens.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         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Timothy C. Griffin    800-248-1199      
Principal Investigator: Timothy C. Griffin         
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Gerardo Quezada    210-575-7000    Gerardo.Quezada@mhshealth.com   
Principal Investigator: Gerardo Quezada         
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    801-585-5270      
Principal Investigator: Phillip E. Barnette         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kimberly P. Dunsmore    434-243-6322    JME3D@hscmail.mcc.virginia.edu   
Principal Investigator: Kimberly P. Dunsmore         
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    757-668-7243    eric.lowe@chkd.org   
Principal Investigator: Eric J. Lowe         
Virginia Commonwealth University/Massey Cancer Center Withdrawn
Richmond, Virginia, United States, 23298
Carilion Clinic Children's Hospital Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mandy M. Atkinson    540-981-7376    mmatkinson@carilionclinic.org   
Principal Investigator: Mandy M. Atkinson         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas S. Hawkins    866-987-2000    doug.hawkins@seattlechildrens.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    800-228-6618    HopeBeginsHere@providence.org   
Principal Investigator: Judy L. Felgenhauer         
Mary Bridge Children's Hospital and Health Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Robert G. Irwin    800-552-1419 ext 3481    robert.irwin@multicare.org   
Principal Investigator: Robert G. Irwin         
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Melissa A. Forouhar    253-968-0129    mamcdci@amedd.army.mil   
Principal Investigator: Melissa A. Forouhar         
United States, West Virginia
West Virginia University Charleston Recruiting
Charleston, West Virginia, United States, 25304
Contact: Chibuzo C. O'Suoji    304-388-9944    ccosuoji@hsc.wvu.edu   
Principal Investigator: Chibuzo C. O'Suoji         
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Stephan R. Paul    304-293-2745    sfilburn@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    715-422-7718      
Principal Investigator: Kenneth B. De Santes         
Midwest Children's Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Paul D. Harker-Murray    414-805-4380    pharker@mcw.edu   
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: Elizabeth L. Hesketh    61-2-49855605    elizabeth.hesketh@hnehealth.nsw.gov.au   
Principal Investigator: Elizabeth L. Hesketh         
The Children's Hospital at Westmead Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Geoffrey B. McCowage    61-2-9845-2171    geoff.mccowage@health.nsw.gov.au   
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    (08) 8161 7327    cywhs.oncsec@health.sa.gov.au   
Principal Investigator: Maria L. Kirby         
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6008
Contact: Catherine H. Cole    08-9340-8222    catherine.cole@health.wa.gov.au   
Principal Investigator: Catherine H. Cole         
Brazil
Instituto De Oncologia Pediatrica Terminated
Sao Paulo, Brazil, 04023-062
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Douglas R. Strother    403-220-6898    research4kids@ucalgary.ca   
Principal Investigator: Douglas R. Strother         
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: David B. Dix    604-875-2345    ddix@cw.bc.ca   
Principal Investigator: David B. Dix         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Rochelle A. Yanofsky    866-561-1026    CIO_Web@cancercare.mb.ca   
Principal Investigator: Rochelle A. Yanofsky         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Conrad V. Fernandez    902-470-7216    conrad.fernandez@iwk.nshealth.ca   
Principal Investigator: Conrad V. Fernandez         
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine    905-521-1703    portwc@mcmaster.ca   
Principal Investigator: Carol Portwine         
Chedoke Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8S 4L8
Contact: Carol Portwine    905-521-2100 ext 74595      
Principal Investigator: Carol Portwine         
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 5P9
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: Jacqueline M. Halton    613-738-3931      
Principal Investigator: Jacqueline M. Halton         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sarah W. Alexander    416-813-5327    jason.mcguire@sickkids.ca   
Principal Investigator: Sarah W. Alexander         
Canada, Quebec
The Montreal Children's Hospital of the MUHC Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon B. Abish    514-412-4301    info@thechildren.com   
Principal Investigator: Sharon B. Abish         
Centre Hospitalier Universitaire Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson    514-345-4792    yvan.samson@umontreal.ca   
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    888-823-5923    ctsucontact@westat.com   
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    81-99-265-7196    okamoto@m2.kufm.kagoshima-u.ac.jp   
Principal Investigator: Yasuhiro Okamoto         
Shizuoka Cancer Center Recruiting
Shizuoka City, Suntou, Japan, 411-8777
Contact: Yuji Ishida    81-55-989-5551    y.ishida@scchr.jp   
Principal Investigator: Yuji Ishida         
Nihon University Itabashi Hospital Recruiting
Itabashi-ku, Tokyo, Japan, 173-8610
Contact: Tsugumichi Koshinaga    81-3-3554-1321    koshinaga.tsugumichi@nihon-u.ac.jp   
Principal Investigator: Tsugumichi Koshinaga         
Hiroshima University Hospital Recruiting
Hiroshima City, Japan, 734-8551
Contact: Eiso Hiyama    82-424-6042      
Principal Investigator: Eiso Hiyama         
National Cancer Center Hospital Recruiting
Tokyo, Japan, 104 0045
Contact: Chitose Ogawa    81-3-6800-5232    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    787-727-1000    luisclavell@sjcms.com   
Principal Investigator: Luis A. Clavell         
University Pediatric Hospital Recruiting
San Juan, Puerto Rico, 00926
Contact: Luis A. Clavell    787-727-1000    luisclavell@sjcms.com   
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  CDR0000654889  COG-AHEP0731  AHEP0731  AHEP0731  U10CA180886  U10CA098543 
Study First Received: September 18, 2009
Last Updated: June 30, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatoblastoma
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Liposomal doxorubicin
Irinotecan
Cisplatin
Doxorubicin
Fluorouracil
Vincristine
Sirolimus
Everolimus
Camptothecin
Liver Extracts
Succinylcholine
Antineoplastic Agents
Hematinics
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

ClinicalTrials.gov processed this record on August 30, 2016