Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Who is this study for? Patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors or favorable histology Wilms tumors that have come back
Status: Recruiting
Location: See all (182) locations...
Intervention Type: Radiation, Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).

Eligibility
Participation Requirements
Sex: All
Maximum Age: 30
Healthy Volunteers: No
View:

• Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN03B2 and have received an initial risk assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a delayed nephrectomy classification showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on AREN03B2 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor.

• Patients must be =< 30 years old at study enrollment

• Patients with the following diagnoses are eligible for this study:

• Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review

• Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as follows, regardless of radiation therapy:

• Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine

• High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan

• Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations

• Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required

• Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of protocol therapy

• Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at initial diagnostic procedure or delayed nephrectomy (such surgery/biopsy is day 0). For patients who received prior therapy for presumed favorable histology Wilms tumor, later confirmed to have diffuse anaplastic Wilms tumor at subsequent review of the initial biopsy

• Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment

• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

• Patients must have a life expectancy of >= 8 weeks

• Diffuse Anaplastic Wilms Tumor: Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations:

• Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor, subsequently confirmed to be diffuse anaplastic Wilms tumor at delayed nephrectomy

• Patients with diffuse anaplastic Wilms tumor who received no more than 6 weeks of chemotherapy following upfront biopsy, initiated within 14 days of biopsy, for presumed favorable histology Wilms tumor based on institutional review, but subsequently corrected to diffuse anaplastic Wilms tumor based on the AREN03B2 initial risk assignment results (if available per current version of AREN03B2)

• Treatment consisting of vincristine/doxorubicin/cyclophosphamide initiated on an emergent basis and within allowed timing as described

• Note: Patients who received prior therapy for presumed favorable histology Wilms tumor, later identified to have diffuse anaplastic Wilms tumor as per above, must begin study treatment starting at cycle 3 (week 7) of regimen UH 3. Patients who received emergency radiation to preserve organ function are eligible as noted. Patients who received radiation as part of standard of care for presumed newly diagnosed favorable histology Wilms tumor, along with chemotherapy as noted above, prior to identification of diffuse anaplasia, are also eligible

• Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis. In addition, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

• Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study

• Radiation therapy (RT): >= 2 weeks (wks) must have elapsed for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial bone marrow (BM) radiation. Patients with relapsed favorable histology Wilms tumor who received emergency radiation to preserve organ function are eligible and do not need to washout with the above criteria

• Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)

• Peripheral absolute neutrophil count (ANC) >= 750/uL (performed within 7 days prior to enrollment)

• Platelet count >= 75,000/uL (transfusion independent) (performed within 7 days prior to enrollment)

• Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (performed within 7 days prior to enrollment)

• Patients with high-risk or very high-risk relapsed FHWT who will be treated with regimen ICE/Cyclo/Topo, must have renal function assessed by creatinine clearance or radioisotope glomerular filtration rate (GFR) and meet the following requirement:

• Creatinine clearance or radioisotope GFR >= 60 mL/min/1.73 m^2 (performed within 7 days prior to enrollment)

• Patients diagnosed with stage 2-4 DAWT or standard risk relapsed FHWT, who will be treated with regimen UH 3, may either obtain a creatinine clearance, radioisotope GFR (meeting the above criteria of GFR >= 60 mL/min/1.73 m^2), or an adequate serum creatinine as per the following table:

• Age: Maximum Serum Creatinine (mg/dL)

• 1 month to < 6 months: 0.4 (male and female)

• 6 months to < 1 year: 0.5 (male and female)

• 1 to < 2 years: 0.6 (male and female)

• 13 to < 16 years: 1.5 (male), 1.4 (female)

• >= 16 years: 1.7 (male), 1.4 (female)

• Total bilirubin =< 1.5 x upper limit of normal (ULN) for age or direct bilirubin =< ULN for patients whose total bilirubin > 1.5 x ULN (performed within 7 days prior to enrollment)

• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age or =< 5 x ULN for patients with liver metastases (performed within 7 days prior to enrollment)

• Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram (obtained within 21 days prior to enrollment and start of protocol therapy)

Locations
United States
Alaska
Providence Alaska Medical Center
Recruiting
Anchorage
Alabama
Children's Hospital of Alabama
Recruiting
Birmingham
USA Health Strada Patient Care Center
Recruiting
Mobile
Arkansas
Arkansas Children's Hospital
Recruiting
Little Rock
Arizona
Banner Children's at Desert
Recruiting
Mesa
Banner University Medical Center - Tucson
Recruiting
Tucson
California
Kaiser Permanente Downey Medical Center
Recruiting
Downey
Loma Linda University Medical Center
Recruiting
Loma Linda
Miller Children's and Women's Hospital Long Beach
Recruiting
Long Beach
Children's Hospital Los Angeles
Recruiting
Los Angeles
Mattel Children's Hospital UCLA
Recruiting
Los Angeles
Valley Children's Hospital
Recruiting
Madera
Kaiser Permanente-Oakland
Recruiting
Oakland
UCSF Benioff Children's Hospital Oakland
Recruiting
Oakland
Children's Hospital of Orange County
Recruiting
Orange
Lucile Packard Children's Hospital Stanford University
Recruiting
Palo Alto
University of California Davis Comprehensive Cancer Center
Recruiting
Sacramento
Rady Children's Hospital - San Diego
Recruiting
San Diego
UCSF Medical Center-Mission Bay
Recruiting
San Francisco
Colorado
Children's Hospital Colorado
Recruiting
Aurora
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Recruiting
Denver
Connecticut
Connecticut Children's Medical Center
Recruiting
Hartford
Washington, D.c.
Children's National Medical Center
Recruiting
Washington
MedStar Georgetown University Hospital
Recruiting
Washington
Delaware
Alfred I duPont Hospital for Children
Recruiting
Wilmington
Florida
Golisano Children's Hospital of Southwest Florida
Recruiting
Fort Myers
University of Florida Health Science Center - Gainesville
Recruiting
Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Recruiting
Hollywood
Nemours Children's Clinic-Jacksonville
Recruiting
Jacksonville
University of Miami Miller School of Medicine-Sylvester Cancer Center
Not yet recruiting
Miami
Arnold Palmer Hospital for Children
Recruiting
Orlando
Nemours Children's Hospital
Recruiting
Orlando
Sacred Heart Hospital
Recruiting
Pensacola
Johns Hopkins All Children's Hospital
Recruiting
Saint Petersburg
Saint Joseph's Hospital/Children's Hospital-Tampa
Recruiting
Tampa
Tampa General Hospital
Recruiting
Tampa
Saint Mary's Hospital
Recruiting
West Palm Beach
Georgia
Children's Healthcare of Atlanta - Egleston
Recruiting
Atlanta
Medical Center of Central Georgia
Recruiting
Macon
Memorial Health University Medical Center
Recruiting
Savannah
Hawaii
Kapiolani Medical Center for Women and Children
Recruiting
Honolulu
Iowa
Blank Children's Hospital
Recruiting
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Recruiting
Iowa City
Idaho
Saint Luke's Cancer Institute - Boise
Recruiting
Boise
Illinois
Lurie Children's Hospital-Chicago
Recruiting
Chicago
University of Chicago Comprehensive Cancer Center
Recruiting
Chicago
University of Illinois
Recruiting
Chicago
Loyola University Medical Center
Recruiting
Maywood
Advocate Children's Hospital-Oak Lawn
Recruiting
Oak Lawn
Advocate Children's Hospital-Park Ridge
Recruiting
Park Ridge
Saint Jude Midwest Affiliate
Recruiting
Peoria
Southern Illinois University School of Medicine
Recruiting
Springfield
Indiana
Riley Hospital for Children
Recruiting
Indianapolis
Kentucky
University of Kentucky/Markey Cancer Center
Recruiting
Lexington
Norton Children's Hospital
Recruiting
Louisville
Louisiana
Children's Hospital New Orleans
Recruiting
New Orleans
Ochsner Medical Center Jefferson
Recruiting
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Recruiting
Boston
Tufts Children's Hospital
Active, not recruiting
Boston
UMass Memorial Medical Center - University Campus
Recruiting
Worcester
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Recruiting
Baltimore
Sinai Hospital of Baltimore
Recruiting
Baltimore
Maine
Eastern Maine Medical Center
Recruiting
Bangor
Maine Children's Cancer Program
Recruiting
Scarborough
Michigan
C S Mott Children's Hospital
Recruiting
Ann Arbor
Michigan State University Clinical Center
Recruiting
East Lansing
Helen DeVos Children's Hospital at Spectrum Health
Recruiting
Grand Rapids
Bronson Methodist Hospital
Recruiting
Kalamazoo
Beaumont Children's Hospital-Royal Oak
Recruiting
Royal Oak
Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Recruiting
Minneapolis
University of Minnesota/Masonic Cancer Center
Recruiting
Minneapolis
Mayo Clinic in Rochester
Recruiting
Rochester
Missouri
Columbia Regional
Recruiting
Columbia
Children's Mercy Hospitals and Clinics
Recruiting
Kansas City
Cardinal Glennon Children's Medical Center
Recruiting
Saint Louis
Mercy Hospital Saint Louis
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Mississippi
University of Mississippi Medical Center
Recruiting
Jackson
North Carolina
Mission Hospital
Recruiting
Asheville
Carolinas Medical Center/Levine Cancer Institute
Recruiting
Charlotte
Novant Health Presbyterian Medical Center
Recruiting
Charlotte
Duke University Medical Center
Recruiting
Durham
East Carolina University
Recruiting
Greenville
Wake Forest University Health Sciences
Recruiting
Winston-salem
North Dakota
Sanford Broadway Medical Center
Recruiting
Fargo
Nebraska
Children's Hospital and Medical Center of Omaha
Recruiting
Omaha
University of Nebraska Medical Center
Recruiting
Omaha
New Jersey
Hackensack University Medical Center
Recruiting
Hackensack
Morristown Medical Center
Recruiting
Morristown
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Recruiting
New Brunswick
Saint Joseph's Regional Medical Center
Recruiting
Paterson
Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Recruiting
Las Vegas
Summerlin Hospital Medical Center
Recruiting
Las Vegas
Sunrise Hospital and Medical Center
Recruiting
Las Vegas
University Medical Center of Southern Nevada
Recruiting
Las Vegas
Renown Regional Medical Center
Recruiting
Reno
New York
Albany Medical Center
Recruiting
Albany
Montefiore Medical Center - Moses Campus
Recruiting
Bronx
Roswell Park Cancer Institute
Recruiting
Buffalo
The Steven and Alexandra Cohen Children's Medical Center of New York
Recruiting
New Hyde Park
Memorial Sloan Kettering Cancer Center
Recruiting
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Recruiting
New York
NYP/Weill Cornell Medical Center
Recruiting
New York
Stony Brook University Medical Center
Recruiting
Stony Brook
State University of New York Upstate Medical University
Recruiting
Syracuse
New York Medical College
Recruiting
Valhalla
Ohio
Children's Hospital Medical Center of Akron
Recruiting
Akron
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati
Cleveland Clinic Foundation
Recruiting
Cleveland
Rainbow Babies and Childrens Hospital
Recruiting
Cleveland
Nationwide Children's Hospital
Recruiting
Columbus
Dayton Children's Hospital
Recruiting
Dayton
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Recruiting
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Oregon
Legacy Emanuel Children's Hospital
Recruiting
Portland
Oregon Health and Science University
Recruiting
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Recruiting
Allentown
Geisinger Medical Center
Recruiting
Danville
Penn State Children's Hospital
Recruiting
Hershey
Children's Hospital of Philadelphia
Recruiting
Philadelphia
Saint Christopher's Hospital for Children
Recruiting
Philadelphia
Children's Hospital of Pittsburgh of UPMC
Recruiting
Pittsburgh
Rhode Island
Rhode Island Hospital
Recruiting
Providence
South Carolina
Medical University of South Carolina
Recruiting
Charleston
Prisma Health Richland Hospital
Recruiting
Columbia
BI-LO Charities Children's Cancer Center
Recruiting
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
Recruiting
Sioux Falls
Tennessee
T C Thompson Children's Hospital
Suspended
Chattanooga
East Tennessee Childrens Hospital
Recruiting
Knoxville
Saint Jude Children's Research Hospital
Recruiting
Memphis
The Children's Hospital at TriStar Centennial
Recruiting
Nashville
Vanderbilt University/Ingram Cancer Center
Recruiting
Nashville
Texas
Texas Tech University Health Sciences Center-Amarillo
Recruiting
Amarillo
Dell Children's Medical Center of Central Texas
Recruiting
Austin
Driscoll Children's Hospital
Recruiting
Corpus Christi
Medical City Dallas Hospital
Recruiting
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Recruiting
Dallas
El Paso Children's Hospital
Recruiting
El Paso
Cook Children's Medical Center
Recruiting
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Recruiting
Houston
M D Anderson Cancer Center
Recruiting
Houston
Covenant Children's Hospital
Recruiting
Lubbock
UMC Cancer Center / UMC Health System
Recruiting
Lubbock
Children's Hospital of San Antonio
Recruiting
San Antonio
Methodist Children's Hospital of South Texas
Recruiting
San Antonio
University of Texas Health Science Center at San Antonio
Not yet recruiting
San Antonio
Utah
Primary Children's Hospital
Recruiting
Salt Lake City
Virginia
Inova Fairfax Hospital
Recruiting
Falls Church
Children's Hospital of The King's Daughters
Recruiting
Norfolk
Virginia Commonwealth University/Massey Cancer Center
Recruiting
Richmond
Carilion Children's
Recruiting
Roanoke
Washington
Seattle Children's Hospital
Recruiting
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
Recruiting
Spokane
Madigan Army Medical Center
Recruiting
Tacoma
Mary Bridge Children's Hospital and Health Center
Recruiting
Tacoma
Wisconsin
University of Wisconsin Carbone Cancer Center
Recruiting
Madison
Marshfield Medical Center-Marshfield
Recruiting
Marshfield
Children's Hospital of Wisconsin
Recruiting
Milwaukee
West Virginia
West Virginia University Charleston Division
Recruiting
Charleston
Other Locations
Australia
Monash Medical Center-Clayton Campus
Recruiting
Clayton
John Hunter Children's Hospital
Recruiting
Hunter Regional Mail Centre
Royal Children's Hospital
Suspended
Parkville
Perth Children's Hospital
Suspended
Perth
Sydney Children's Hospital
Recruiting
Randwick
Queensland Children's Hospital
Suspended
South Brisbane
The Children's Hospital at Westmead
Recruiting
Westmead
Canada
Alberta Children's Hospital
Recruiting
Calgary
University of Alberta Hospital
Recruiting
Edmonton
IWK Health Centre
Recruiting
Halifax
McMaster Children's Hospital at Hamilton Health Sciences
Recruiting
Hamilton
Children's Hospital
Recruiting
London
Centre Hospitalier Universitaire Sainte-Justine
Recruiting
Montreal
The Montreal Children's Hospital of the MUHC
Recruiting
Montreal
Children's Hospital of Eastern Ontario
Recruiting
Ottawa
Centre Hospitalier Universitaire de Quebec
Recruiting
Quebec
Hospital for Sick Children
Recruiting
Toronto
British Columbia Children's Hospital
Suspended
Vancouver
CancerCare Manitoba
Recruiting
Winnipeg
New Zealand
Christchurch Hospital
Recruiting
Christchurch
Starship Children's Hospital
Recruiting
Grafton
Puerto Rico
HIMA San Pablo Oncologic Hospital
Recruiting
Caguas
University Pediatric Hospital
Recruiting
San Juan
Time Frame
Start Date: September 18, 2020
Estimated Completion Date: July 1, 2027
Participants
Target number of participants: 221
Treatments
Experimental: Arm I (Regimen UH-3)
See outline in detailed description section.
Experimental: Arm II (Regimen ICE/Cyclo/Topo)
CYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.~CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity.~Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Authors
Craig Erker, Valeria Smith, Hamayun Imran, Kelly L. Vallance, Elyssa M. Rubin, Robin Y. Dulman, Haydar A. Frangoul, Nina S. Kadan-Lottick, Alissa Kahn, Sarah B. Whittle, Kathryn L. Laurie, Marcio H. Malogolowkin, Jessica C. Hochberg, Mary L. Schmidt, Julio C. Barredo, Eric J. Lowe, Michael W. Bishop, Nadine P. SantaCruz, Mariko Sato, Ashok B. Raj, Frances Austin, Keith J. August, Kishor M. Bhende, Lisa Gennarini, Stanton C. Goldman, Sushmita Nair, Thomas W. McLean, Michael S. Isakoff, Justine M. Kahn, Kayelyn J. Wagner, Mukund G. Dole, David L. Becton, Laura E. Agresta, Lars M. Wagner, Phillip E. Barnette, Matthew Dietz, Rabi Hanna, Timothy C. Griffin, Katrina Winsnes, Robin D. Hanson, Juan F. Rico, Erwood G. Edwards, Ranjan Bista, Jennifer A. Domm, Don E. Eslin, William B. Slayton, Lolie C. Yu, Iftikhar Hanif, Mark A. Ranalli, David S. Dickens, Pooja Hingorani, Erin K. Barr, Leo Mascarenhas, Erin Wright, Laura E. Hogan, Jamie L. Dargart, Jason Law, Duncan S. Stearns, Andrew L. Pendleton, Barbara A. Gruner, Lisa G. Roth, Jose M. Esquilin, Aarati V. Rao, Joseph C. Torkildson, Michelle A. Manalang, Clare J. Twist, Craig Lotterman, Erlyn C. Smith, Aniket Saha, Maria E. Echevarria, Noah C. Federman, Elizabeth A. Mullen, Eugenia Chang, Aghiad Chamdin, Emily G. Greengard, Victor A. Lewis, Meghann P. McManus, James T. Badgett, Robert G. Irwin, Carla B. Golden, Elizabeth D. Alva, Susan E. Spiller, Douglas J. Scothorn, Eugene Suh, Ami V. Desai, Jonathan L. Metts, Aaron R. Weiss, Judy L. Felgenhauer, Jacob A. Troutman, Minnie Abromowitch, Wade T. Kyono, Amy A. Smith, William D. Roberts, Gregory P. Brandt, William S. Ferguson, Alan D. Friedman, Lisa M. McGregor, Neha G. Vaghasia, Laura A. Campbell, Jennifer J. Welch, Jagadeesh Ramdas, Philip M. Monteleone, Stuart L. Cramer, Andrea R. Whitfield, Jay Michael S. Balagtas, Joel A. Kaplan, Jean M. Tersak, Daniel J. Benedetti, Gregory E. Halligan, Brenda J. Wittman, Samuel J. Milanovich, Katharine Offer, Alan K. Ikeda, Samantha L. Mallory, Nkechi I. Mba, Amy L. Walz, Janice F. Olson, Laura K. Gowans, Rebecca E. McFall, Narayana Gowda, Michael K. Richards, Steven J. Kuerbitz, Meghen B. Browning, James I Geller, Alice Lee, Lauren R. Weintraub, Jeffrey H. Schwartz, Wendy Allen-Rhoades, Jason M. Fixler, Jill C. Beck, Jonathan E. Wickiser, Jennifer J. Clark, Melissa K. Bear, Jessica A. Bell, Frank M. Balis, Albert Kheradpour, Jeffrey S. Dome, Melissa A. Forouhar, Mohamad H. Badawi, Stefanie R. Lowas, John J. Gregory, Arun A. Rangaswami, Emad K. Salman, Douglas R. Strother, Jhon A. Guerra, Kenneth B. De Santes, Steven A. Foresto, Elizabeth L. Hesketh, Michael V. Ortiz, Karen S. Fernandez, Amy Armstrong, Andrew L. Hong, Michelina de la Maza, Timothy P. Garrington, Martin A. Campbell, Jacqueline N. Casillas, Mandy PohLui de Silva, Jane E. Skeen, Paul J. Wood, Ashley Chopek, Sharon B. Abish, Carolyn F. Levy, Amanda J. Lyver, Yvan Samson, Anne-Marie R. Langevin, Donna L. Johnston, David B. Dix, Shannon M. Cohn, Najat C. Daw, Uma H. Athale, Jacqueline M. Kraveka, Scott Moerdler, Daniel A. Morgenstern, Rachel C. Brennan, Shayna M. Zelcer, Rene Y. McNall-Knapp, Bhavna Padhye, David E. Kram, Kathleen J. Yost, Jaime M. Libes, Marianne B. Phillips, Draga Barbaric, Samer Zaid Kaylani, Rama Jasty, Sarah J. McKillop, Ramamoorthy Nagasubramanian, Sarah E. Leary, Anderson (Andy) B. Collier, Bruno Michon
Sponsors
Leads: Children's Oncology Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials