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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIITissue collection/Repository, Treatment21 and underAHEP0731
NCI-2011-01975, CDR0000654889, COG-AHEP0731, NCT02265692, PAHEP0731_A08PAMDREVW01, NCT00980460

Trial Description

Summary

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

Further Study Information

PRIMARY OBJECTIVES:

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

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

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

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

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

SECONDARY OBJECTIVES:

I. To estimate the EFS of patients with stage I PFH treated with surgery alone.

II. To determine whether orthotopic liver transplantation (OLT) can be accomplished after successful referral and completion of 4 cycles of initial chemotherapy.

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

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

V. To determine if pretreatment extent of disease (PRETEXT) grouping can predict tumor resectability.

VI. To monitor the concordance between institutional assessment of PRETEXT grouping and PRETEXT grouping as performed by expert panel review.

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

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

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

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

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

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

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

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

Eligibility Criteria

Inclusion Criteria:

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)

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

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

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

All patients and/or their parents or legal guardians must sign a written informed consent

Prothrombin time (PT) < 1.2 x ULN

Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and if seizures are well controlled

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

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

Serum cholesterol level =< 300 mg/dL (7.75 mmol/L)

Serum triglyceride level =< 300 mg/dL (=< 3.42 mmol/L)

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

Shortening fraction >= 27% by echocardiogram

Platelet count > 75,000/uL

Absolute neutrophil count (ANC) > 750/uL

Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x ULN for age

Total bilirubin < 1.5 x upper limit of normal (ULN) for age

Organ function requirements are not required for enrolled patients who are stage I, PFH and will not be receiving chemotherapy

Patients may have had surgical resection of some or all sites of hepatoblastoma prior to enrollment

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 will be staged for risk classification and treatment at diagnosis using Children's Oncology Group (COG) staging guidelines

Patients must be newly diagnosed with histologically-proven hepatoblastoma

All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

Patients who are currently receiving angiotensin-converting enzymes (ACE) inhibitors are not eligible

Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, warfarin and others) 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 enzyme inducing anticonvulsants are not eligible

Patients receiving corticosteroids are not eligible; patients must have been off corticosteroids for 7 days prior to start of chemotherapy

Males and females of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method

Female patients of childbearing potential are not eligible unless a negative pregnancy text result has been obtained

Females who are pregnant or breast feeding are not eligible for this study

Patients who have an uncontrolled infection are not eligible

Patients who are currently receiving other anticancer agents are not eligible

Patients who are currently receiving another investigational drug are not eligible

Patients who have received any prior chemotherapy are not eligible

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 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 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

Patients who have previously received a solid organ transplant are not eligible

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

National Cancer Institute

  • National Cancer Institute
Howard Mark Katzenstein, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

Children's Hospital of Alabama

Alyssa Terry Reddy
Ph: 888-823-5923
Email: ctsucontact@westat.com

Alyssa Terry Reddy
Principal Investigator

Arizona
Phoenix

Phoenix Childrens Hospital

Jessica Boklan
Ph: 602-546-0920

Jessica Boklan
Principal Investigator

Tucson

The University of Arizona Medical Center-University Campus

Lisa M. Kopp
Ph: 520-626-9008

Lisa M. Kopp
Principal Investigator

Arkansas
Little Rock

Arkansas Children's Hospital

David L. Becton
Ph: 501-364-7373

David L. Becton
Principal Investigator

California
Downey

Southern California Permanente Medical Group

Robert Michael Cooper
Ph: 626-564-3455

Robert Michael Cooper
Principal Investigator

Loma Linda

Loma Linda University Medical Center

Antranik A. Bedros
Ph: 909-558-3375

Antranik A. Bedros
Principal Investigator

Long Beach

Miller Children's and Women's Hospital Long Beach

Theodore Zwerdling
Ph: 562-933-5600

Theodore Zwerdling
Principal Investigator

Los Angeles

Cedars-Sinai Medical Center

Fataneh (Fae) Majlessipour
Ph: 310-423-8965

Fataneh (Fae) Majlessipour
Principal Investigator

Children's Hospital Los Angeles

Leo Mascarenhas
Ph: 323-361-4110

Leo Mascarenhas
Principal Investigator

Madera

Children's Hospital Central California

Vonda Lee Crouse
Ph: 866-353-5437

Vonda Lee Crouse
Principal Investigator

Oakland

Children's Hospital and Research Center at Oakland

Carla Barbara Golden
Ph: 510-450-7600

Carla Barbara Golden
Principal Investigator

Kaiser Permanente-Oakland

Steven K. Bergstrom
Ph: 626-564-3455

Steven K. Bergstrom
Principal Investigator

Orange

Childrens Hospital of Orange County

Violet Shen
Ph: 714-997-3000

Violet Shen
Principal Investigator

Palo Alto

Lucile Packard Children's Hospital Stanford University

Neyssa Maria Marina
Ph: 650-498-7061
Email: clinicaltrials@med.stanford.edu

Neyssa Maria Marina
Principal Investigator

Sacramento

Sutter General Hospital

Howard Mark Katzenstein
Ph: 888-785-1112

Howard Mark Katzenstein
Principal Investigator

San Diego

Rady Children's Hospital - San Diego

William D. Roberts
Ph: 858-966-5934

William D. Roberts
Principal Investigator

San Francisco

UCSF Medical Center-Mission Bay

Robert Edward Goldsby
Ph: 877-827-3222

Robert Edward Goldsby
Principal Investigator

Colorado
Aurora

Children's Hospital Colorado

Brian Scott Greffe
Ph: 720-777-6672

Brian Scott Greffe
Principal Investigator

Denver

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Jennifer Jocelyn Clark
Ph: 866-775-6246

Jennifer Jocelyn Clark
Principal Investigator

Connecticut
Hartford

Connecticut Children's Medical Center

Michael Scott Isakoff
Ph: 860-545-9981

Michael Scott Isakoff
Principal Investigator

New Haven

Yale University

Nina Singh Kadan-Lottick
Ph: 203-785-5702

Nina Singh Kadan-Lottick
Principal Investigator

Delaware
Wilmington

Alfred I duPont Hospital for Children

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Ramamoorthy Nagasubramanian
Principal Investigator

District of Columbia
Washington

Children's National Medical Center

Jeffrey Stuart Dome
Ph: 202-884-2549

Jeffrey Stuart Dome
Principal Investigator

MedStar Georgetown University Hospital

Aziza Tahir Shad
Ph: 202-444-0381

Aziza Tahir Shad
Principal Investigator

Florida
Fort Lauderdale

Broward Health Medical Center

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

Hector M. Rodriguez-Cortes
Principal Investigator

Fort Myers

Golisano Children's Hospital of Southwest Florida

Emad K. Salman
Ph: 239-343-5333

Emad K. Salman
Principal Investigator

Gainesville

University of Florida

William Birdsall Slayton
Ph: 352-273-8675
Email: trials@cancer.ufl.edu

William Birdsall Slayton
Principal Investigator

Hollywood

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Iftikhar Hanif
Ph: 954-265-2234

Iftikhar Hanif
Principal Investigator

Jacksonville

Nemours Children's Clinic-Jacksonville

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Ramamoorthy Nagasubramanian
Principal Investigator

Miami

Baptist Hospital of Miami

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

Doured Daghistani
Principal Investigator

University of Miami Miller School of Medicine-Sylvester Cancer Center

Julio Cesar Barredo
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Julio Cesar Barredo
Principal Investigator

Orlando

Arnold Palmer Hospital for Children

Vincent Ferdinando Giusti
Ph: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com

Vincent Ferdinando Giusti
Principal Investigator

Florida Hospital Orlando

Fouad M. Hajjar
Ph: 407-303-5623

Fouad M. Hajjar
Principal Investigator

Nemours Children's Hospital

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Ramamoorthy Nagasubramanian
Principal Investigator

Pensacola

Nemours Children's Clinic - Pensacola

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Ramamoorthy Nagasubramanian
Principal Investigator

Saint Petersburg

All Children's Hospital

Gregory Alan Hale
Ph: 727-767-2423
Email: HamblinF@allkids.org

Gregory Alan Hale
Principal Investigator

Tampa

Saint Joseph's Hospital/Children's Hospital-Tampa

Dana Ann Obzut
Ph: 800-882-4123

Dana Ann Obzut
Principal Investigator

West Palm Beach

Saint Mary's Hospital

Narayana Gowda
Ph: 888-823-5923
Email: ctsucontact@westat.com

Narayana Gowda
Principal Investigator

Georgia
Atlanta

Children's Healthcare of Atlanta - Egleston

Glen Lew
Ph: 404-785-1112

Glen Lew
Principal Investigator

Savannah

Memorial University Medical Center

J. Martin Johnston
Ph: 912-350-8568

J. Martin Johnston
Principal Investigator

Hawaii
Honolulu

Kapiolani Medical Center for Women and Children

Robert W. Wilkinson
Ph: 808-983-6090

Robert W. Wilkinson
Principal Investigator

Tripler Army Medical Center

Jeremy Vaughan Edwards
Ph: 808-433-6336

Jeremy Vaughan Edwards
Principal Investigator

Idaho
Boise

Saint Luke's Mountain States Tumor Institute

Eugenia Chang
Ph: 800-845-4624

Eugenia Chang
Principal Investigator

Illinois
Chicago

Lurie Children's Hospital-Chicago

Yasmin Castellanes Gosiengfiao
Ph: 773-880-4562

Yasmin Castellanes Gosiengfiao
Principal Investigator

University of Chicago Comprehensive Cancer Center

Susan Lerner Cohn
Ph: 773-834-7424

Susan Lerner Cohn
Principal Investigator

University of Illinois

Mary Lou Schmidt
Ph: 312-355-3046

Mary Lou Schmidt
Principal Investigator

Maywood

Loyola University Medical Center

Eugene Suh
Ph: 708-226-4357

Eugene Suh
Principal Investigator

Oak Lawn

Advocate Children's Hospital-Oak Lawn

Rebecca Erin McFall
Ph: 847-723-7570

Rebecca Erin McFall
Principal Investigator

Park Ridge

Advocate Children's Hospital-Park Ridge

Jong-Hyo Kwon
Ph: 847-384-3621

Jong-Hyo Kwon
Principal Investigator

Peoria

Saint Jude Midwest Affiliate

Karen Sofia Fernandez
Ph: 309-655-3258

Karen Sofia Fernandez
Principal Investigator

Springfield

Southern Illinois University School of Medicine

Gregory P. Brandt
Ph: 217-545-7929

Gregory P. Brandt
Principal Investigator

Indiana
Indianapolis

Riley Hospital for Children

Robert J. Fallon
Ph: 888-823-5923
Email: ctsucontact@westat.com

Robert J. Fallon
Principal Investigator

Saint Vincent Hospital and Health Services

Bassem I. Razzouk
Ph: 317-338-2194

Bassem I. Razzouk
Principal Investigator

Iowa
Des Moines

Blank Children's Hospital

Wendy Leigh Woods-Swafford
Ph: 515-241-6729

Wendy Leigh Woods-Swafford
Principal Investigator

Iowa City

University of Iowa/Holden Comprehensive Cancer Center

Mariko Sato
Ph: 800-237-1225

Mariko Sato
Principal Investigator

Kentucky
Lexington

University of Kentucky/Markey Cancer Center

Lars Martin Wagner
Ph: 859-257-3379

Lars Martin Wagner
Principal Investigator

Louisville

Kosair Children's Hospital

Kenneth G. Lucas
Ph: 866-530-5516

Kenneth G. Lucas
Principal Investigator

Louisiana
New Orleans

Children's Hospital New Orleans

Lolie C. Yu
Ph: 504-894-5377

Lolie C. Yu
Principal Investigator

Ochsner Medical Center Jefferson

Craig Lotterman
Ph: 888-562-4763

Craig Lotterman
Principal Investigator

Maine
Scarborough

Maine Children's Cancer Program

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

Eric C. Larsen
Principal Investigator

Maryland
Baltimore

Sinai Hospital of Baltimore

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

Joseph M. Wiley
Principal Investigator

Bethesda

Walter Reed National Military Medical Center

Anne Benedicta Warwick
Ph: 301-319-2100

Anne Benedicta Warwick
Principal Investigator

Massachusetts
Boston

Dana-Farber Cancer Institute

Carlos Rodriguez-Galindo
Ph: 877-442-3324

Carlos Rodriguez-Galindo
Principal Investigator

Worcester

University of Massachusetts Medical School

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

Christopher P. Keuker
Principal Investigator

Michigan
Ann Arbor

C S Mott Children's Hospital

Brenda Joyce Kitchen
Ph: 248-551-7695

Brenda Joyce Kitchen
Principal Investigator

Detroit

Wayne State University/Karmanos Cancer Institute

Jeffrey Warren Taub
Ph: 313-576-9363

Jeffrey Warren Taub
Principal Investigator

East Lansing

Michigan State University Clinical Center

Renuka Gera
Ph: 517-975-9547

Renuka Gera
Principal Investigator

Flint

Hurley Medical Center

Susumu Inoue
Ph: 888-606-6556

Susumu Inoue
Principal Investigator

Grand Rapids

Helen DeVos Children's Hospital at Spectrum Health

David Scott Dickens
Ph: 616-267-1925

David Scott Dickens
Principal Investigator

Kalamazoo

Bronson Methodist Hospital

Jeffrey S. Lobel
Ph: 800-227-2345

Jeffrey S. Lobel
Principal Investigator

Kalamazoo Center for Medical Studies

Jeffrey S. Lobel
Ph: 800-227-2345

Jeffrey S. Lobel
Principal Investigator

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

Bruce Charles Bostrom
Ph: 612-813-5193

Bruce Charles Bostrom
Principal Investigator

University of Minnesota Medical Center-Fairview

Brenda J. Weigel
Ph: 612-624-2620

Brenda J. Weigel
Principal Investigator

Rochester

Mayo Clinic

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

Carola A. S. Arndt
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center

Gail Cranshaw Megason
Ph: 601-815-6700

Gail Cranshaw Megason
Principal Investigator

Missouri
Columbia

Columbia Regional

Thomas W. Loew
Ph: 573-882-7440

Thomas W. Loew
Principal Investigator

Kansas City

The Childrens Mercy Hospital

Maxine Lorraine Hetherington
Ph: 816-234-3265

Maxine Lorraine Hetherington
Principal Investigator

Saint Louis

Mercy Hospital Saint Louis

Bethany Graham Sleckman
Ph: 913-948-5588

Bethany Graham Sleckman
Principal Investigator

Washington University School of Medicine

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

David Brian Wilson
Principal Investigator

Nebraska
Omaha

Children's Hospital and Medical Center of Omaha

Minnie Abromowitch
Ph: 402-955-3949

Minnie Abromowitch
Principal Investigator

University of Nebraska Medical Center

Minnie Abromowitch
Ph: 402-955-3949

Minnie Abromowitch
Principal Investigator

Nevada
Las Vegas

Children's Specialty Center of Nevada II

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Nevada Cancer Research Foundation CCOP

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Summerlin Hospital Medical Center

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Sunrise Hospital and Medical Center

Nik Farahana Nik Abdul Rashid
Ph: 702-384-0013

Nik Farahana Nik Abdul Rashid
Principal Investigator

New Hampshire
Lebanon

Dartmouth Hitchcock Medical Center

Sara Chaffee
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

Sara Chaffee
Principal Investigator

New Jersey
Hackensack

Hackensack University Medical Center

Michael Bertram Harris
Ph: 201-996-2879

Michael Bertram Harris
Principal Investigator

Morristown

Morristown Medical Center

Steven Lon Halpern
Ph: 973-971-5900

Steven Lon Halpern
Principal Investigator

New Brunswick

Saint Peter's University Hospital

Stanley Calderwood
Ph: 732-745-8600ext6163
Email: kcovert@saintpetersuh.com

Stanley Calderwood
Principal Investigator

UMDNJ - Robert Wood Johnson University Hospital

Richard A. Drachtman
Ph: 732-235-8675

Richard A. Drachtman
Principal Investigator

Newark

Newark Beth Israel Medical Center

Peri Kamalakar
Ph: 973-926-7230

Peri Kamalakar
Principal Investigator

Paterson

Saint Joseph's Regional Medical Center

Mary Ann Bonilla
Ph: 973-754-2909

Mary Ann Bonilla
Principal Investigator

Summit

Overlook Hospital

Steven Lon Halpern
Ph: 973-971-5900

Steven Lon Halpern
Principal Investigator

New Mexico
Albuquerque

University of New Mexico Cancer Center

Koh B. Boayue
Ph: 505-272-6972

Koh B. Boayue
Principal Investigator

New York
Albany

Albany Medical Center

Vikramjit Singh Kanwar
Ph: 518-262-3368

Vikramjit Singh Kanwar
Principal Investigator

Bronx

Montefiore Medical Center - Moses Campus

Peter David Cole
Ph: 718-904-2730
Email: aecc@aecom.yu.edu

Peter David Cole
Principal Investigator

Buffalo

Roswell Park Cancer Institute

Martin Louis Brecher
Ph: 877-275-7724

Martin Louis Brecher
Principal Investigator

Mineola

Winthrop University Hospital

Mark E. Weinblatt
Ph: 866-946-8476

Mark E. Weinblatt
Principal Investigator

New Hyde Park

The Steven and Alexandra Cohen Children's Medical Center of New York

Carolyn Fein Levy
Ph: 718-470-3470

Carolyn Fein Levy
Principal Investigator

New York

Columbia University Medical Center

Alice Lee
Ph: 212-305-8615

Alice Lee
Principal Investigator

Laura and Issac Perlmutter Cancer Center at NYU Langone

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

Linda Granowetter
Principal Investigator

Memorial Sloan-Kettering Cancer Center

Peter Gustav Steinherz
Ph: 212-639-7202

Peter Gustav Steinherz
Principal Investigator

Mount Sinai Medical Center

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

Birte Wistinghausen
Principal Investigator

Syracuse

State University of New York Upstate Medical University

Karol Hicks Kerr
Ph: 315-464-5476

Karol Hicks Kerr
Principal Investigator

Valhalla

New York Medical College

Jessica Cassara Hochberg
Ph: 914-594-3794

Jessica Cassara Hochberg
Principal Investigator

North Carolina
Asheville

Mission Hospital-Memorial Campus

Douglas James Scothorn
Ph: 828-213-4150

Douglas James Scothorn
Principal Investigator

Chapel Hill

University of North Carolina at Chapel Hill

Stuart Harrison Gold
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Stuart Harrison Gold
Principal Investigator

Charlotte

Carolinas Medical Center/Levine Cancer Institute

Joel A. Kaplan
Ph: 704-355-2884

Joel A. Kaplan
Principal Investigator

Novant Health Presbyterian Medical Center

Paulette Charese Bryant
Ph: 704-384-5369

Paulette Charese Bryant
Principal Investigator

Durham

Duke University Medical Center

Susan G. Kreissman
Ph: 888-275-3853

Susan G. Kreissman
Principal Investigator

Greenville

East Carolina University

George Edward Hucks
Ph: 252-744-2391

George Edward Hucks
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

Thomas Williams McLean
Ph: 336-713-6771

Thomas Williams McLean
Principal Investigator

Ohio
Akron

Children's Hospital Medical Center of Akron

Steven J. Kuerbitz
Ph: 330-543-3193

Steven J. Kuerbitz
Principal Investigator

Cincinnati

Cincinnati Children's Hospital Medical Center

John Peter Perentesis
Ph: 513-636-2799

John Peter Perentesis
Principal Investigator

Cleveland

Cleveland Clinic Foundation

Margaret C. Thompson
Ph: 866-223-8100

Margaret C. Thompson
Principal Investigator

Rainbow Babies and Childrens Hospital

Yousif (Joe) H. Matloub
Ph: 216-844-5437

Yousif (Joe) H. Matloub
Principal Investigator

Columbus

Nationwide Children's Hospital

Mark Anthony Ranalli
Ph: 614-722-2708

Mark Anthony Ranalli
Principal Investigator

Dayton

Dayton Children's Hospital

Ayman Ali El-Sheikh
Ph: 800-237-1225

Ayman Ali El-Sheikh
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Rene Yvonne McNall-Knapp
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Rene Yvonne McNall-Knapp
Principal Investigator

Oregon
Portland

Legacy Emanuel Children's Hospital

Janice Faye Olson
Ph: 503-413-2560

Janice Faye Olson
Principal Investigator

Legacy Emanuel Hospital and Health Center

Janice Faye Olson
Ph: 503-413-2560

Janice Faye Olson
Principal Investigator

Oregon Health and Science University

Suman Malempati
Ph: 503-494-1080
Email: trials@ohsu.edu

Suman Malempati
Principal Investigator

Pennsylvania
Hershey

Penn State Hershey Children's Hospital

Lisa MacNabb McGregor
Ph: 717-531-6012

Lisa MacNabb McGregor
Principal Investigator

Philadelphia

Children's Hospital of Philadelphia

Edward F. Attiyeh
Ph: 215-590-2810

Edward F. Attiyeh
Principal Investigator

Saint Christopher's Hospital for Children

Akash Nahar
Ph: 215-427-8991

Akash Nahar
Principal Investigator

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Arthur Kim Ritchey
Ph: 412-692-5573

Arthur Kim Ritchey
Principal Investigator

PR
San Juan

San Jorge Children's Hospital

Luis A. Clavell
Ph: 787-765-2363

Luis A. Clavell
Principal Investigator

Rhode Island
Providence

Rhode Island Hospital

Jennifer J. Greene Welch
Ph: 401-444-1488

Jennifer J. Greene Welch
Principal Investigator

South Carolina
Columbia

Palmetto Health Richland

Ronnie W. Neuberg
Ph: 803-434-3680

Ronnie W. Neuberg
Principal Investigator

Greenville

BI-LO Charities Children's Cancer Center

Nichole Leigh Bryant
Ph: 864-241-6251

Nichole Leigh Bryant
Principal Investigator

Greenville Cancer Treatment Center

Cary E. Stroud
Ph: 864-241-6251

Cary E. Stroud
Principal Investigator

Tennessee
Memphis

St. Jude Children's Research Hospital

Wayne Lee Furman
Ph: 866-278-5833
Email: info@stjude.org

Wayne Lee Furman
Principal Investigator

Nashville

Vanderbilt University/Ingram Cancer Center

Scott C. Borinstein
Ph: 800-811-8480

Scott C. Borinstein
Principal Investigator

Texas
Austin

Dell Children's Medical Center of Central Texas

Amy Catherine Fowler
Ph: 214-648-7097

Amy Catherine Fowler
Principal Investigator

Corpus Christi

Driscoll Children's Hospital

M. Cris Johnson
Ph: 361-694-5311

M. Cris Johnson
Principal Investigator

Dallas

Medical City Dallas Hospital

Stanton Carl Goldman
Ph: 972-566-5588

Stanton Carl Goldman
Principal Investigator

UT Southwestern/Simmons Cancer Center-Dallas

Jonathan Eric Wickiser
Ph: 214-648-7097

Jonathan Eric Wickiser
Principal Investigator

Fort Worth

Cook Children's Medical Center

Mary Meaghan Petty Granger
Ph: 682-885-2103

Mary Meaghan Petty Granger
Principal Investigator

Houston

Baylor College of Medicine

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

Patrick Andrew Thompson
Principal Investigator

San Antonio

Children's Hospital of San Antonio

Timothy C. Griffin
Ph: 713-798-1354
Email: burton@bcm.edu

Timothy C. Griffin
Principal Investigator

Methodist Children's Hospital of South Texas

Jaime Estrada
Ph: 210-575-7000

Jaime Estrada
Principal Investigator

University of Texas Health Science Center at San Antonio

Anne-Marie R. Langevin
Ph: 210-450-3800
Email: CTO@uthscsa.edu

Anne-Marie R. Langevin
Principal Investigator

Temple

Scott and White Memorial Hospital

Guy Howard Grayson
Ph: 254-724-5407

Guy Howard Grayson
Principal Investigator

Utah
Salt Lake City

Primary Children's Hospital

Phillip Evan Barnette
Ph: 801-585-5270

Phillip Evan Barnette
Principal Investigator

Virginia
Charlottesville

University of Virginia Cancer Center

Kimberly Panter Dunsmore
Ph: 434-243-6143

Kimberly Panter Dunsmore
Principal Investigator

Falls Church

Inova Fairfax Hospital

Marshall A. Schorin
Ph: 703-208-6650

Marshall A. Schorin
Principal Investigator

Norfolk

Childrens Hospital-King's Daughters

Eric Jeffrey Lowe
Ph: 757-668-7243

Eric Jeffrey Lowe
Principal Investigator

Richmond

Virginia Commonwealth University/Massey Cancer Center

Gita Vasers Massey
Ph: 804-628-1939

Gita Vasers Massey
Principal Investigator

Roanoke

Carilion Clinic Children's Hospital

Mandy Meck Atkinson
Ph: 540-981-7376

Mandy Meck Atkinson
Principal Investigator

Washington
Seattle

Seattle Children's Hospital

Douglas S. Hawkins
Ph: 866-987-2000

Douglas S. Hawkins
Principal Investigator

Spokane

Providence Sacred Heart Medical Center and Children's Hospital

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

Judy L. Felgenhauer
Principal Investigator

Tacoma

Madigan Army Medical Center

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

Melissa Anne Forouhar
Principal Investigator

Mary Bridge Children's Hospital and Health Center

Robert G. Irwin
Ph: 253-403-3229

Robert G. Irwin
Principal Investigator

West Virginia
Charleston

West Virginia University Charleston

Howard Michael Grodman
Ph: 304-388-9944

Howard Michael Grodman
Principal Investigator

Morgantown

West Virginia University Healthcare

Stephan R. Paul
Ph: 304-293-2745
Email: sfilburn@hsc.wvu.edu

Stephan R. Paul
Principal Investigator

Wisconsin
Madison

University of Wisconsin Hospital and Clinics

Kenneth Brian DeSantes
Ph: 608-262-5223

Kenneth Brian DeSantes
Principal Investigator

Milwaukee

Midwest Children's Cancer Center

Sachin S. Jogal
Ph: 414-805-4380

Sachin S. Jogal
Principal Investigator

Australia

Westmead

The Children's Hospital at Westmead

Geoffrey Brian McCowage
Ph: 61-2-9845 1400

Geoffrey Brian McCowage
Principal Investigator

Canada

Alberta
Calgary

Alberta Children's Hospital

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

Douglas R. Strother
Principal Investigator

British Columbia
Vancouver

British Columbia Children's Hospital

Caron Strahlendorf
Ph: 604-875-2345ext6477

Caron Strahlendorf
Principal Investigator

Manitoba
Winnipeg

CancerCare Manitoba

Rochelle Avis Yanofsky
Ph: 866-561-1026
Email: CIO_Web@cancercare.mb.ca

Rochelle Avis Yanofsky
Principal Investigator

Nova Scotia
Halifax

IWK Health Centre

Conrad Vincent Fernandez
Ph: 902-470-8394

Conrad Vincent Fernandez
Principal Investigator

Ontario
Hamilton

Chedoke Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100ext74595

Carol Portwine
Principal Investigator

McMaster Children's Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100ext74595

Carol Portwine
Principal Investigator

Kingston

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Mariana Pradier Silva
Ph: 613-544-2630

Mariana Pradier Silva
Principal Investigator

Ottawa

Children's Hospital of Eastern Ontario

Jacqueline Mary Lewis Halton
Ph: 613-738-3931

Jacqueline Mary Lewis Halton
Principal Investigator

Quebec
Montreal

Centre Hospitalier Universitaire Sainte-Justine

Yvan Samson
Ph: 514-345-4931

Yvan Samson
Principal Investigator

The Montreal Children's Hospital of the MUHC

Sharon Barbara Abish
Ph: 514-412-4445
Email: info@thechildren.com

Sharon Barbara Abish
Principal Investigator

Quebec

Centre Hospitalier Universitaire de Quebec

Bruno Michon
Ph: 418-525-4444

Bruno Michon
Principal Investigator

Saskatchewan
Saskatoon

Saskatoon Cancer Centre

Christopher Mpofu
Ph: 306-655-2914

Christopher Mpofu
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00980460

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.