Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer
Conditions
PRETEXT Stage 1 Hepatoblastoma - PRETEXT Stage 2 Hepatoblastoma - PRETEXT Stage 3 Hepatoblastoma - PRETEXT Stage 4 Hepatoblastoma
Conditions: official terms
Hepatoblastoma
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cisplatin Type: Drug
Name: Doxorubicin Hydrochloride Type: Drug
Name: Fluorouracil Type: Drug
Name: Irinotecan Hydrochloride Type: Drug
Name: Laboratory Biomarker Analysis Type: Other
Name: Liver Transplantation Type: Procedure
Name: Temsirolimus Type: Drug
Name: Therapeutic Conventional Surgery Type: Procedure
Name: Vincristine Sulfate Type: Drug
Overall Status
Recruiting
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 21 Years
Minimum Age: N/A
Gender: Both
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
Locations
Children's Hospital of Alabama
Birmingham, Alabama, United States
Status: Recruiting
Contact: Alyssa T. Reddy - 888-823-5923 - ctsucontact@westat.com
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Status: Withdrawn
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Status: Recruiting
Contact: Jessica Boklan - 602-546-0920
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States
Status: Recruiting
Contact: Lisa M. Kopp - 520-626-9008
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Status: Recruiting
Contact: David L. Becton - 501-364-7373
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Status: Withdrawn
Southern California Permanente Medical Group
Downey, California, United States
Status: Recruiting
Contact: Robert M. Cooper - 626-564-3455
Loma Linda University Medical Center
Loma Linda, California, United States
Status: Recruiting
Contact: Antranik A. Bedros - 909-558-3375
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States
Status: Recruiting
Contact: Theodore Zwerdling - 562-933-5600
Cedars-Sinai Medical Center
Los Angeles, California, United States
Status: Recruiting
Contact: Fataneh (Fae) Majlessipour - 310-423-8965
Children's Hospital Los Angeles
Los Angeles, California, United States
Status: Recruiting
Contact: Leo Mascarenhas - 323-361-4110
Children's Hospital Central California
Madera, California, United States
Status: Recruiting
Contact: Vonda L. Crouse - 866-353-5437
Children's Hospital and Research Center at Oakland
Oakland, California, United States
Status: Recruiting
Contact: Carla B. Golden - 510-450-7600
Kaiser Permanente-Oakland
Oakland, California, United States
Status: Recruiting
Contact: Steven K. Bergstrom - 626-564-3455
Childrens Hospital of Orange County
Orange, California, United States
Status: Recruiting
Contact: Violet Shen - 714-997-3000
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
Status: Recruiting
Contact: Neyssa M. Marina - 650-498-7061 - clinicaltrials@med.stanford.edu
Sutter General Hospital
Sacramento, California, United States
Status: Recruiting
Contact: Howard M. Katzenstein - 888-785-1112
Rady Children's Hospital - San Diego
San Diego, California, United States
Status: Recruiting
Contact: William D. Roberts - 858-966-5934
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Status: Recruiting
Contact: Robert E. Goldsby - 877-827-3222
UCSF Medical Center-Parnassus
San Francisco, California, United States
Status: Withdrawn
Children's Hospital Colorado
Aurora, Colorado, United States
Status: Recruiting
Contact: Brian S. Greffe - 720-777-6672
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States
Status: Recruiting
Contact: Jennifer J. Clark - 866-775-6246
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Status: Recruiting
Contact: Michael S. Isakoff - 860-545-9981
Yale University
New Haven, Connecticut, United States
Status: Recruiting
Contact: Nina S. Kadan-Lottick - 203-785-5702
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States
Status: Recruiting
Contact: Ramamoorthy Nagasubramanian - 407-650-7150
Children's National Medical Center
Washington, District of Columbia, United States
Status: Recruiting
Contact: Jeffrey S. Dome - 202-884-2549
MedStar Georgetown University Hospital
Washington, District of Columbia, United States
Status: Recruiting
Contact: Aziza T. Shad - 202-444-0381
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Status: Recruiting
Contact: Hector M. Rodriguez-Cortes - 954-355-5346
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Status: Recruiting
Contact: Emad K. Salman - 239-343-5333
Lee Memorial Health System
Fort Myers, Florida, United States
Status: Withdrawn
University of Florida
Gainesville, Florida, United States
Status: Recruiting
Contact: William B. Slayton - 352-273-8675 - trials@cancer.ufl.edu
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Status: Recruiting
Contact: Iftikhar Hanif - 954-265-2234
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States
Status: Recruiting
Contact: Ramamoorthy Nagasubramanian - 407-650-7150
Baptist Hospital of Miami
Miami, Florida, United States
Status: Recruiting
Contact: Doured Daghistani - 800-599-2456 - cancerinfo@baptisthealth.net
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Status: Recruiting
Contact: Julio C. Barredo - 866-574-5124 - Sylvester@emergingmed.com
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Status: Recruiting
Contact: Vincent F. Giusti - 321-841-7246 - CancerClinicalTrials@orlandohealth.com
Florida Hospital Orlando
Orlando, Florida, United States
Status: Recruiting
Contact: Fouad M. Hajjar - 407-303-5623
Nemours Children's Clinic - Orlando
Orlando, Florida, United States
Status: Withdrawn
Nemours Children's Hospital
Orlando, Florida, United States
Status: Recruiting
Contact: Ramamoorthy Nagasubramanian - 407-650-7150
UF Cancer Center at Orlando Health
Orlando, Florida, United States
Status: Withdrawn
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
Status: Recruiting
Contact: Ramamoorthy Nagasubramanian - 407-650-7150
All Children's Hospital
Saint Petersburg, Florida, United States
Status: Recruiting
Contact: Gregory A. Hale - 727-767-2423 - HamblinF@allkids.org
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States
Status: Recruiting
Contact: Dana A. Obzut - 800-882-4123
Saint Mary's Hospital
West Palm Beach, Florida, United States
Status: Recruiting
Contact: Narayana Gowda - 888-823-5923 - ctsucontact@westat.com
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States
Status: Recruiting
Contact: Glen Lew - 404-785-1112
Memorial University Medical Center
Savannah, Georgia, United States
Status: Recruiting
Contact: J. M. Johnston - 912-350-8568
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Robert W. Wilkinson - 808-983-6090
Tripler Army Medical Center
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeremy V. Edwards - 808-433-6336
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Status: Withdrawn
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Status: Recruiting
Contact: Eugenia Chang - 800-845-4624
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States
Status: Recruiting
Contact: Yasmin C. Gosiengfiao - 773-880-4562
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Status: Recruiting
Contact: Susan L. Cohn - 773-834-7424
University of Illinois
Chicago, Illinois, United States
Status: Recruiting
Contact: Mary L. Schmidt - 312-355-3046
Loyola University Medical Center
Maywood, Illinois, United States
Status: Recruiting
Contact: Eugene Suh - 708-226-4357
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States
Status: Recruiting
Contact: Rebecca E. McFall - 847-723-7570
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, United States
Status: Recruiting
Contact: Jong-Hyo Kwon - 847-384-3621
Advocate Lutheran General Hospital.
Park Ridge, Illinois, United States
Status: Withdrawn
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
Status: Recruiting
Contact: Karen S. Fernandez - 309-655-3258
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Status: Recruiting
Contact: Gregory P. Brandt - 217-545-7929
Riley Hospital for Children
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Robert J. Fallon - 888-823-5923 - ctsucontact@westat.com
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Bassem I. Razzouk - 317-338-2194
Blank Children's Hospital
Des Moines, Iowa, United States
Status: Recruiting
Contact: Wendy L. Woods-Swafford - 515-241-6729
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Status: Recruiting
Contact: Ayman A. El-Sheikh - 800-237-1225
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Status: Recruiting
Contact: Lars M. Wagner - 859-257-3379
Kosair Children's Hospital
Louisville, Kentucky, United States
Status: Recruiting
Contact: Kenneth G. Lucas - 866-530-5516
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Status: Recruiting
Contact: Lolie C. Yu - 504-894-5377
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Status: Recruiting
Contact: Craig Lotterman - 888-562-4763
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Status: Withdrawn
Eastern Maine Medical Center
Bangor, Maine, United States
Status: Active, not recruiting
Maine Children's Cancer Program
Scarborough, Maine, United States
Status: Recruiting
Contact: Eric C. Larsen - 207-396-8090 - wrighd@mmc.org
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Status: Recruiting
Contact: Joseph M. Wiley - 410-601-6120 - pridgely@lifebridgehealth.org
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Status: Recruiting
Contact: Anne B. Warwick - 301-319-2100
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Carlos Rodriguez-Galindo - 877-442-3324
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Status: Active, not recruiting
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Status: Recruiting
Contact: Christopher P. Keuker - 508-856-3216 - cancer.research@umassmed.edu
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Brenda J. Kitchen - 248-551-7695
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Status: Recruiting
Contact: Jeffrey W. Taub - 313-576-9363
Michigan State University Clinical Center
East Lansing, Michigan, United States
Status: Recruiting
Contact: Renuka Gera - 517-975-9547
Hurley Medical Center
Flint, Michigan, United States
Status: Recruiting
Contact: Susumu Inoue - 888-606-6556
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Status: Recruiting
Contact: David S. Dickens - 616-267-1925
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Status: Recruiting
Contact: Jeffrey S. Lobel - 800-227-2345
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, United States
Status: Recruiting
Contact: Jeffrey S. Lobel - 800-227-2345
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Bruce C. Bostrom - 612-813-5193
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Brenda J. Weigel - 612-624-2620
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Contact: Carola A. Arndt - 507-538-7623
University of Mississippi Medical Center
Jackson, Mississippi, United States
Status: Recruiting
Contact: Gail C. Megason - 601-815-6700
Columbia Regional
Columbia, Missouri, United States
Status: Recruiting
Contact: Thomas W. Loew - 573-882-7440
University of Missouri - Ellis Fischel
Columbia, Missouri, United States
Status: Withdrawn
The Childrens Mercy Hospital
Kansas City, Missouri, United States
Status: Recruiting
Contact: Maxine L. Hetherington - 816-234-3265
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Bethany G. Sleckman - 913-948-5588
Washington University School of Medicine
Saint Louis, Missouri, United States
Status: Recruiting
Contact: David B. Wilson - 800-600-3606 - info@siteman.wustl.edu
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States
Status: Recruiting
Contact: Minnie Abromowitch - 402-955-3949
University of Nebraska Medical Center
Omaha, Nebraska, United States
Status: Recruiting
Contact: Minnie Abromowitch - 402-955-3949
Children's Specialty Center of Nevada II
Las Vegas, Nevada, United States
Status: Recruiting
Contact: Jonathan Bernstein - 702-384-0013
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Status: Recruiting
Contact: Jonathan Bernstein - 702-384-0013
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States
Status: Recruiting
Contact: Jonathan Bernstein - 702-384-0013
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Status: Recruiting
Contact: Nik Farahana N. Rashid - 702-384-0013
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Status: Recruiting
Contact: Sara Chaffee - 800-639-6918 - cancer.research.nurse@dartmouth.edu
Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Contact: Michael B. Harris - 201-996-2879
Morristown Medical Center
Morristown, New Jersey, United States
Status: Recruiting
Contact: Steven L. Halpern - 973-971-5900
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Status: Recruiting
Contact: Stanley Calderwood - 732-745-8600 - kcovert@saintpetersuh.com
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Status: Recruiting
Contact: Richard A. Drachtman - 732-235-8675
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Status: Recruiting
Contact: Peri Kamalakar - 973-926-7230
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States
Status: Recruiting
Contact: Mary A. Bonilla - 973-754-2909
Overlook Hospital
Summit, New Jersey, United States
Status: Recruiting
Contact: Steven L. Halpern - 973-971-5900
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Status: Recruiting
Contact: Koh B. Boayue - 505-272-6972
Albany Medical Center
Albany, New York, United States
Status: Recruiting
Contact: Vikramjit S. Kanwar - 518-262-3368
Montefiore Medical Center - Moses Campus
Bronx, New York, United States
Status: Recruiting
Contact: Peter D. Cole - 718-904-2730 - aecc@aecom.yu.edu
Roswell Park Cancer Institute
Buffalo, New York, United States
Status: Recruiting
Contact: Martin L. Brecher - 877-275-7724
Winthrop University Hospital
Mineola, New York, United States
Status: Recruiting
Contact: Mark E. Weinblatt - 866-946-8476
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Status: Recruiting
Contact: Carolyn F. Levy - 718-470-3470
Columbia University Medical Center
New York, New York, United States
Status: Recruiting
Contact: Alice Lee - 212-305-8615
Laura and Issac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Status: Recruiting
Contact: Linda Granowetter - 212-263-4434 - prmc.coordinator@nyumc.org
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Peter G. Steinherz - 212-639-7202
Mount Sinai Medical Center
New York, New York, United States
Status: Recruiting
Contact: Birte Wistinghausen - 212-824-7320 - jenny.figueroa@mssm.edu
University of Rochester
Rochester, New York, United States
Status: Active, not recruiting
State University of New York Upstate Medical University
Syracuse, New York, United States
Status: Recruiting
Contact: Karol H. Kerr - 315-464-5476
New York Medical College
Valhalla, New York, United States
Status: Recruiting
Contact: Jessica C. Hochberg - 914-594-3794
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States
Status: Recruiting
Contact: Douglas J. Scothorn - 828-213-4150
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: Stuart H. Gold - 877-668-0683 - cancerclinicaltrials@med.unc.edu
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Status: Recruiting
Contact: Joel A. Kaplan - 704-355-2884
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Status: Recruiting
Contact: Paulette C. Bryant - 704-384-5369
Duke University Medical Center
Durham, North Carolina, United States
Status: Recruiting
Contact: Susan G. Kreissman - 888-275-3853
East Carolina University
Greenville, North Carolina, United States
Status: Recruiting
Contact: George E. Hucks - 252-744-2391
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Status: Recruiting
Contact: Thomas W. McLean - 336-713-6771
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Status: Recruiting
Contact: Steven J. Kuerbitz - 330-543-3193
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Status: Recruiting
Contact: John P. Perentesis - 513-636-2799
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Status: Recruiting
Contact: Margaret C. Thompson - 866-223-8100
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States
Status: Recruiting
Contact: Yousif (Joe) H. Matloub - 216-844-5437
Nationwide Children's Hospital
Columbus, Ohio, United States
Status: Recruiting
Contact: Mark A. Ranalli - 614-722-2708
Dayton Children's Hospital
Dayton, Ohio, United States
Status: Recruiting
Contact: Ayman A. El-Sheikh - 800-237-1225
Mercy Children's Hospital
Toledo, Ohio, United States
Status: Terminated
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Status: Recruiting
Contact: Rene Y. McNall-Knapp - 405-271-4272 - julie-traylor@ouhsc.edu
Legacy Emanuel Children's Hospital
Portland, Oregon, United States
Status: Recruiting
Contact: Janice F. Olson - 503-413-2560
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Status: Recruiting
Contact: Janice F. Olson - 503-413-2560
Oregon Health and Science University
Portland, Oregon, United States
Status: Recruiting
Contact: Suman Malempati - 503-494-1080 - trials@ohsu.edu
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Status: Recruiting
Contact: Lisa M. McGregor - 717-531-6012
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Edward F. Attiyeh - 215-590-2810
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Akash Nahar - 215-427-8991
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Arthur K. Ritchey - 412-692-5573
Rhode Island Hospital
Providence, Rhode Island, United States
Status: Recruiting
Contact: Jennifer J. Greene Welch - 401-444-1488
Palmetto Health Richland
Columbia, South Carolina, United States
Status: Recruiting
Contact: Ronnie W. Neuberg - 803-434-3680
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States
Status: Recruiting
Contact: Nichole L. Bryant - 864-241-6251
Greenville Cancer Treatment Center
Greenville, South Carolina, United States
Status: Recruiting
Contact: Cary E. Stroud - 864-241-6251
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States
Status: Active, not recruiting
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States
Status: Active, not recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Status: Recruiting
Contact: Wayne L. Furman - 866-278-5833 - info@stjude.org
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Scott C. Borinstein - 800-811-8480
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Status: Recruiting
Contact: Amy C. Fowler - 214-648-7097
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Status: Recruiting
Contact: M. C. Johnson - 361-694-5311
Medical City Dallas Hospital
Dallas, Texas, United States
Status: Recruiting
Contact: Stanton C. Goldman - 972-566-5588
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Status: Recruiting
Contact: Jonathan E. Wickiser - 214-648-7097
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Status: Active, not recruiting
Cook Children's Medical Center
Fort Worth, Texas, United States
Status: Recruiting
Contact: Mary Meaghan P. Granger - 682-885-2103
Baylor College of Medicine
Houston, Texas, United States
Status: Recruiting
Contact: Patrick A. Thompson - 877-668-0683 - cancerclinicaltrials@med.unc.edu
Children's Hospital of San Antonio
San Antonio, Texas, United States
Status: Recruiting
Contact: Timothy C. Griffin - 713-798-1354 - burton@bcm.edu
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
Status: Recruiting
Contact: Jaime Estrada - 210-575-7000
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Status: Recruiting
Contact: Anne-Marie R. Langevin - 210-450-3800 - CTO@uthscsa.edu
Scott and White Memorial Hospital
Temple, Texas, United States
Status: Recruiting
Contact: Guy H. Grayson - 254-724-5407
Primary Children's Hospital
Salt Lake City, Utah, United States
Status: Recruiting
Contact: Phillip E. Barnette - 801-585-5270
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Status: Recruiting
Contact: Kimberly P. Dunsmore - 434-243-6143
Inova Fairfax Hospital
Falls Church, Virginia, United States
Status: Recruiting
Contact: Marshall A. Schorin - 703-208-6650
Childrens Hospital-King's Daughters
Norfolk, Virginia, United States
Status: Recruiting
Contact: Eric J. Lowe - 757-668-7243
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Status: Recruiting
Contact: Gita V. Massey - 804-628-1939
Carilion Clinic Children's Hospital
Roanoke, Virginia, United States
Status: Recruiting
Contact: Mandy M. Atkinson - 540-981-7376
Seattle Children's Hospital
Seattle, Washington, United States
Status: Recruiting
Contact: Douglas S. Hawkins - 866-987-2000
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
Status: Recruiting
Contact: Judy L. Felgenhauer - 800-228-6618 - HopeBeginsHere@providence.org
Madigan Army Medical Center
Tacoma, Washington, United States
Status: Recruiting
Contact: Melissa A. Forouhar - 253-968-0129 - mamcdci@amedd.army.mil
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States
Status: Recruiting
Contact: Robert G. Irwin - 253-403-3229
West Virginia University Charleston
Charleston, West Virginia, United States
Status: Recruiting
Contact: Howard M. Grodman - 304-388-9944
West Virginia University Healthcare
Morgantown, West Virginia, United States
Status: Recruiting
Contact: Stephan R. Paul - 304-293-2745 - sfilburn@hsc.wvu.edu
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Status: Recruiting
Contact: Kenneth B. DeSantes - 608-262-5223
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Sachin S. Jogal - 414-805-4380
John Hunter Children's Hospital
Hunter Regional Mail Centre, New South Wales, Australia
Status: Active, not recruiting
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Status: Recruiting
Contact: Geoffrey B. McCowage - 61-2-9845 1400
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, Australia
Status: Active, not recruiting
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Status: Active, not recruiting
Instituto De Oncologia Pediatrica
Sao Paulo, Brazil
Status: Terminated
Alberta Children's Hospital
Calgary, Alberta, Canada
Status: Recruiting
Contact: Douglas R. Strother - 403-220-6898 - research4kids@ucalgary.ca
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Status: Recruiting
Contact: Caron Strahlendorf - 604-875-2345
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Status: Recruiting
Contact: Rochelle A. Yanofsky - 866-561-1026 - CIO_Web@cancercare.mb.ca
IWK Health Centre
Halifax, Nova Scotia, Canada
Status: Recruiting
Contact: Conrad V. Fernandez - 902-470-8394
Chedoke Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Status: Recruiting
Contact: Carol Portwine - 905-521-2100
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Status: Recruiting
Contact: Carol Portwine - 905-521-2100
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Status: Recruiting
Contact: Mariana P. Silva - 613-544-2630
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Status: Recruiting
Contact: Jacqueline M. Halton - 613-738-3931
Hospital for Sick Children
Toronto, Ontario, Canada
Status: Active, not recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Status: Recruiting
Contact: Yvan Samson - 514-345-4931
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada
Status: Recruiting
Contact: Sharon B. Abish - 514-412-4445 - info@thechildren.com
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Status: Recruiting
Contact: Christopher Mpofu - 306-655-2914
Centre Hospitalier Universitaire de Quebec
Quebec, Canada
Status: Recruiting
Contact: Bruno Michon - 418-525-4444
San Jorge Children's Hospital
San Juan, Puerto Rico
Status: Recruiting
Contact: Luis A. Clavell - 787-765-2363
Start Date
September 2009
Sponsors
National Cancer Institute (NCI)
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page