A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

Who is this study for? Patients up to age 40 with rhabdomyosarcoma
Status: Suspended
Location: See all (387) locations...
Intervention Type: Radiation, Drug, Biological, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used 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. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether chemotherapy plus temsirolimus is more effective than chemotherapy alone in treating patients with intermediate-risk rhabdomyosarcoma.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 40
Healthy Volunteers: No
View:

• Feasibility Phase: Patients must be < 21 years of age at the time of enrollment; please note: the feasibility phase is complete, effective with amendment #1

• Efficacy Phase: Patients must be =< 40 years of age at the time of enrollment

• Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon stage, group, and age, as below

• RMS types included under embryonal rhabdomyosarcoma (ERMS) include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2013 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant); classification of alveolar rhabdomyosarcoma (ARMS) in the 2013 WHO classification is the same as in the ICR and includes classic and solid variants

• ERMS

• Stage 1, group III (non-orbit)

• Stage 3, group I/II

• Stage 4, group IV, < 10 years old

• ARMS:

• Stages 1-3, groups I-III

• Specimen Submission: Patients must have sufficient tissue available for the required biology study

• Lansky performance status score >= 50 for patients =< 16 years of age; Karnofsky performance status score >= 50 for patients > 16 years of age

• Peripheral absolute neutrophil count (ANC) >= 750/uL

• Platelet count >= 75,000/uL

• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

• 1 month to < 6 months old: 0.4 mg/dl (male), 0.4 mg/dl (female)

• 6 months to < 1 year old: 0.5 mg/dl (male), 0.5 mg/dl (female)

• 1 to < 2 years old: 0.6 mg/dl (male), 0.6 mg/dl (female)

• >= 16 years old: 1.7 mg/dl (male), 1.4 mg/dl (female)

• Patients with an elevated serum creatinine due to obstructive hydronephrosis secondary to tumor are still eligible; however, patients with urinary tract obstruction by tumor must have unimpeded urinary flow established via diversion (i.e. percutaneous nephrostomies or ureteric stents) of the urinary tract

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

• 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.

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska Oncology and Hematology LLC
Anchorage
Alaska Women's Cancer Care
Anchorage
Anchorage Associates in Radiation Medicine
Anchorage
Anchorage Oncology Centre
Anchorage
Anchorage Radiation Therapy Center
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
Alabama
Children's Hospital of Alabama
Birmingham
USA Health Strada Patient Care Center
Mobile
Arkansas
Arkansas Children's Hospital
Little Rock
Arizona
Kingman Regional Medical Center
Kingman
Banner Children's at Desert
Mesa
Mayo Clinic Hospital in Arizona
Phoenix
Phoenix Childrens Hospital
Phoenix
Mayo Clinic in Arizona
Scottsdale
Banner University Medical Center - Tucson
Tucson
California
Kaiser Permanente-Anaheim
Anaheim
PCR Oncology
Arroyo Grande
Kaiser Permanente-Bellflower
Bellflower
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
Kaiser Permanente Downey Medical Center
Downey
Kaiser Permanente-Fontana
Fontana
Loma Linda University Medical Center
Loma Linda
Children's Hospital Los Angeles
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Mattel Children's Hospital UCLA
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles
Valley Children's Hospital
Madera
Kaiser Permanente-Oakland
Oakland
UCSF Benioff Children's Hospital Oakland
Oakland
Children's Hospital of Orange County
Orange
Lucile Packard Children's Hospital Stanford University
Palo Alto
Kaiser Permanente-Roseville
Roseville
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
Kaiser Permanente-San Diego Mission
San Diego
Naval Medical Center -San Diego
San Diego
Rady Children's Hospital - San Diego
San Diego
UCSF Medical Center-Mission Bay
San Francisco
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance
Colorado
Children's Hospital Colorado
Aurora
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver
Connecticut
Connecticut Children's Medical Center
Hartford
Smilow Cancer Center/Yale-New Haven Hospital
New Haven
Yale University
New Haven
Smilow Cancer Hospital Care Center-Trumbull
Trumbull
Washington, D.c.
Children's National Medical Center
Washington
Kaiser Permanente-Capitol Hill Medical Center
Washington
MedStar Georgetown University Hospital
Washington
Sibley Memorial Hospital
Washington
Delaware
Alfred I duPont Hospital for Children
Wilmington
Florida
Broward Health Medical Center
Fort Lauderdale
Golisano Children's Hospital of Southwest Florida
Fort Myers
University of Florida Health Science Center - Gainesville
Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood
Nemours Children's Clinic-Jacksonville
Jacksonville
Palms West Radiation Therapy
Loxahatchee Groves
Miami Cancer Institute
Miami
Nicklaus Children's Hospital
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
AdventHealth Orlando
Orlando
Arnold Palmer Hospital for Children
Orlando
Nemours Children's Hospital
Orlando
Nemours Children's Clinic - Pensacola
Pensacola
Sacred Heart Hospital
Pensacola
Johns Hopkins All Children's Hospital
Saint Petersburg
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa
Tampa General Hospital
Tampa
Saint Mary's Hospital
West Palm Beach
Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta
Augusta University Medical Center
Augusta
Medical Center of Central Georgia
Macon
Memorial Health University Medical Center
Savannah
Hawaii
Kaiser Permanente Moanalua Medical Center
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Straub Clinic and Hospital
Honolulu
Iowa
Blank Children's Hospital
Des Moines
Iowa Lutheran Hospital
Des Moines
Iowa Methodist Medical Center
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Idaho
Saint Luke's Cancer Institute - Boise
Boise
Saint Luke's Cancer Institute - Fruitland
Fruitland
Saint Luke's Cancer Institute - Meridian
Meridian
Saint Luke's Cancer Institute - Nampa
Nampa
Saint Luke's Cancer Institute - Twin Falls
Twin Falls
Illinois
John H Stroger Jr Hospital of Cook County
Chicago
Lurie Children's Hospital-Chicago
Chicago
Rush University Medical Center
Chicago
University of Chicago Comprehensive Cancer Center
Chicago
University of Illinois
Chicago
Loyola University Medical Center
Maywood
Advocate Children's Hospital-Oak Lawn
Oak Lawn
Advocate Children's Hospital-Park Ridge
Park Ridge
Saint Jude Midwest Affiliate
Peoria
Memorial Medical Center
Springfield
Saint John's Hospital
Springfield
Southern Illinois University School of Medicine
Springfield
Indiana
Ascension Saint Vincent Indianapolis Hospital
Indianapolis
Riley Hospital for Children
Indianapolis
Kentucky
University of Kentucky/Markey Cancer Center
Lexington
Norton Children's Hospital
Louisville
Louisiana
Children's Hospital New Orleans
New Orleans
Ochsner Medical Center Jefferson
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Boston
Massachusetts General Hospital Cancer Center
Boston
Tufts Children's Hospital
Boston
UMass Memorial Medical Center - University Campus
Worcester
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
Sinai Hospital of Baltimore
Baltimore
University of Maryland/Greenebaum Cancer Center
Baltimore
Walter Reed National Military Medical Center
Bethesda
Maine
Eastern Maine Medical Center
Bangor
Maine Children's Cancer Program
Scarborough
Michigan
C S Mott Children's Hospital
Ann Arbor
University of Michigan Comprehensive Cancer Center
Ann Arbor
Bronson Battle Creek
Battle Creek
Ascension Saint John Hospital
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
Michigan State University Clinical Center
East Lansing
Hurley Medical Center
Flint
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids
Mercy Health Saint Mary's
Grand Rapids
Spectrum Health at Butterworth Campus
Grand Rapids
Borgess Medical Center
Kalamazoo
Bronson Methodist Hospital
Kalamazoo
West Michigan Cancer Center
Kalamazoo
Sparrow Hospital
Lansing
Mercy Health Mercy Campus
Muskegon
Lakeland Hospital Niles
Niles
Huron Medical Center PC
Port Huron
Lake Huron Medical Center
Port Huron
Spectrum Health Reed City Hospital
Reed City
Beaumont Children's Hospital-Royal Oak
Royal Oak
Lakeland Medical Center Saint Joseph
Saint Joseph
Marie Yeager Cancer Center
Saint Joseph
Munson Medical Center
Traverse City
Metro Health Hospital
Wyoming
Minnesota
Essentia Health Cancer Center
Duluth
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis
University of Minnesota/Masonic Cancer Center
Minneapolis
Mayo Clinic in Rochester
Rochester
Missouri
Columbia Regional
Columbia
Siteman Cancer Center at West County Hospital
Creve Coeur
Children's Mercy Hospitals and Clinics
Kansas City
Barnes-Jewish Hospital
Saint Louis
Cardinal Glennon Children's Medical Center
Saint Louis
Mercy Hospital Saint Louis
Saint Louis
Washington University School of Medicine
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Saint Peters
Mississippi
University of Mississippi Medical Center
Jackson
Montana
Saint Patrick Hospital - Community Hospital
Missoula
North Carolina
Mission Hospital
Asheville
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
Charlotte
Novant Health Carolina Surgical - Randolph
Charlotte
Novant Health Presbyterian Medical Center
Charlotte
Oncology Specialists of Charlotte
Charlotte
Southern Oncology Specialists-Charlotte
Charlotte
Duke University Medical Center
Durham
East Carolina University
Greenville
Novant Health Cancer Institute - Huntersville
Huntersville
Novant Health Presbyterian Medical Center Huntersville
Huntersville
Southern Oncology Specialists-Huntersville
Huntersville
Matthews Radiation Oncology Center
Matthews
Novant Health Cancer Institute - Matthews
Matthews
Lake Norman Radiation Oncology Center-Mooresville
Mooresville
Novant Health Cancer Institute - Mooresville
Mooresville
Novant Health Cancer Institute - Rowan
Salisbury
Rowan Regional Medical Center
Salisbury
Wake Forest University Health Sciences
Winston-salem
North Dakota
Sanford Broadway Medical Center
Fargo
Nebraska
Children's Hospital and Medical Center of Omaha
Omaha
University of Nebraska Medical Center
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
New Jersey
Hackensack University Medical Center
Hackensack
Morristown Medical Center
Morristown
Rutgers Cancer Institute of New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick
Saint Peter's University Hospital
New Brunswick
Newark Beth Israel Medical Center
Newark
Saint Joseph's Regional Medical Center
Paterson
New Mexico
Presbyterian Hospital
Albuquerque
Nevada
Carson Tahoe Regional Medical Center
Carson City
Cancer and Blood Specialists-Henderson
Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson
GenesisCare USA - Henderson
Henderson
Las Vegas Cancer Center-Henderson
Henderson
Las Vegas Urology - Green Valley
Henderson
Las Vegas Urology - Pebble
Henderson
OptumCare Cancer Care at Seven Hills
Henderson
Urology Specialists of Nevada - Green Valley
Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas
Ann M Wierman MD LTD
Las Vegas
Cancer and Blood Specialists-Shadow
Las Vegas
Cancer and Blood Specialists-Tenaya
Las Vegas
Cancer Therapy and Integrative Medicine
Las Vegas
Comprehensive Cancer Centers of Nevada
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas
Desert West Surgery
Las Vegas
GenesisCare USA - Fort Apache
Las Vegas
GenesisCare USA - Las Vegas
Las Vegas
GenesisCare USA - Vegas Tenaya
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas
Las Vegas Cancer Center-Medical Center
Las Vegas
Las Vegas Urology - Cathedral Rock
Las Vegas
Las Vegas Urology - Pecos
Las Vegas
Las Vegas Urology - Smoke Ranch
Las Vegas
Las Vegas Urology - Sunset
Las Vegas
OptumCare Cancer Care at Charleston
Las Vegas
OptumCare Cancer Care at Fort Apache
Las Vegas
OptumCare Cancer Care at MountainView
Las Vegas
Radiation Oncology Centers of Nevada Central
Las Vegas
Radiation Oncology Centers of Nevada Southeast
Las Vegas
Summerlin Hospital Medical Center
Las Vegas
Sunrise Hospital and Medical Center
Las Vegas
University Cancer Center
Las Vegas
University Medical Center of Southern Nevada
Las Vegas
Urology Specialists of Nevada - Central
Las Vegas
Urology Specialists of Nevada - Northwest
Las Vegas
Urology Specialists of Nevada - Southwest
Las Vegas
Hope Cancer Care of Nevada-Pahrump
Pahrump
Radiation Oncology Associates
Reno
Renown Regional Medical Center
Reno
Saint Mary's Regional Medical Center
Reno
New York
Albany Medical Center
Albany
Children's Hospital at Montefiore
Bronx
Montefiore Medical Center - Moses Campus
Bronx
Montefiore Medical Center-Einstein Campus
Bronx
Montefiore Medical Center-Weiler Hospital
Bronx
Maimonides Medical Center
Brooklyn
Roswell Park Cancer Institute
Buffalo
Glens Falls Hospital
Glens Falls
NYU Winthrop Hospital
Mineola
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
Memorial Sloan Kettering Cancer Center
New York
Mount Sinai Hospital
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York
University of Rochester
Rochester
Stony Brook University Medical Center
Stony Brook
State University of New York Upstate Medical University
Syracuse
New York Medical College
Valhalla
Westchester Medical Center
Valhalla
Ohio
Children's Hospital Medical Center of Akron
Akron
Cincinnati Children's Hospital Medical Center
Cincinnati
Cleveland Clinic Foundation
Cleveland
Rainbow Babies and Childrens Hospital
Cleveland
Nationwide Children's Hospital
Columbus
Dayton Children's Hospital
Dayton
ProMedica Flower Hospital
Sylvania
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Saint Charles Health System
Bend
Clackamas Radiation Oncology Center
Clackamas
Providence Cancer Institute Clackamas Clinic
Clackamas
Bay Area Hospital
Coos Bay
Providence Newberg Medical Center
Newberg
Legacy Emanuel Children's Hospital
Portland
Oregon Health and Science University
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown
Lehigh Valley Hospital - Muhlenberg
Bethlehem
Geisinger Medical Center
Danville
Penn State Children's Hospital
Hershey
Children's Hospital of Philadelphia
Philadelphia
Saint Christopher's Hospital for Children
Philadelphia
Children's Hospital of Pittsburgh of UPMC
Pittsburgh
Rhode Island
Rhode Island Hospital
Providence
South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Medical University of South Carolina
Charleston
Prisma Health Cancer Institute - Laurens
Clinton
Prisma Health Richland Hospital
Columbia
Prisma Health Cancer Institute - Easley
Easley
BI-LO Charities Children's Cancer Center
Greenville
Prisma Health Cancer Institute - Butternut
Greenville
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Saint Francis Cancer Center
Greenville
Saint Francis Hospital
Greenville
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
South Dakota
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
T C Thompson Children's Hospital
Chattanooga
East Tennessee Childrens Hospital
Knoxville
The Children's Hospital at TriStar Centennial
Nashville
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
Texas Tech University Health Sciences Center-Amarillo
Amarillo
Dell Children's Medical Center of Central Texas
Austin
Driscoll Children's Hospital
Corpus Christi
Medical City Dallas Hospital
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
El Paso Children's Hospital
El Paso
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston
M D Anderson Cancer Center
Houston
Covenant Children's Hospital
Lubbock
Texas Tech University Health Sciences Center-Lubbock
Lubbock
UMC Cancer Center / UMC Health System
Lubbock
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio
Children's Hospital of San Antonio
San Antonio
Methodist Children's Hospital of South Texas
San Antonio
University Hospital
San Antonio
University of Texas Health Science Center at San Antonio
San Antonio
Scott and White Memorial Hospital
Temple
Utah
Primary Children's Hospital
Salt Lake City
Virginia
University of Virginia Cancer Center
Charlottesville
Inova Fairfax Hospital
Falls Church
Children's Hospital of The King's Daughters
Norfolk
Naval Medical Center - Portsmouth
Portsmouth
Virginia Commonwealth University/Massey Cancer Center
Richmond
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin
University of Vermont and State Agricultural College
Burlington
University of Vermont Medical Center
Burlington
Washington
Providence Regional Cancer System-Aberdeen
Aberdeen
Overlake Medical Center
Bellevue
PeaceHealth Saint Joseph Medical Center
Bellingham
Providence Regional Cancer System-Centralia
Centralia
Swedish Cancer Institute-Edmonds
Edmonds
Providence Regional Cancer Partnership
Everett
Swedish Cancer Institute-Issaquah
Issaquah
Kadlec Clinic Hematology and Oncology
Kennewick
Providence Regional Cancer System-Lacey
Lacey
PeaceHealth Saint John Medical Center
Longview
Kaiser Permanente Washington
Seattle
Pacific Gynecology Specialists
Seattle
Seattle Children's Hospital
Seattle
Swedish Medical Center-Ballard Campus
Seattle
Swedish Medical Center-Cherry Hill
Seattle
Swedish Medical Center-First Hill
Seattle
University of Washington Medical Center - Montlake
Seattle
Providence Regional Cancer System-Shelton
Shelton
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - North
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Spokane Valley
Madigan Army Medical Center
Tacoma
Mary Bridge Children's Hospital and Health Center
Tacoma
PeaceHealth Southwest Medical Center
Vancouver
Providence Saint Mary Regional Cancer Center
Walla Walla
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima
Providence Regional Cancer System-Yelm
Yelm
Wisconsin
Gundersen Lutheran Medical Center
La Crosse
University of Wisconsin Carbone Cancer Center
Madison
Marshfield Medical Center-Marshfield
Marshfield
Children's Hospital of Wisconsin
Milwaukee
West Virginia
United Hospital Center
Bridgeport
West Virginia University Charleston Division
Charleston
WVUH-Berkely Medical Center
Martinsburg
West Virginia University Healthcare
Morgantown
Camden Clark Medical Center
Parkersburg
Other Locations
Australia
John Hunter Children's Hospital
Hunter Regional Mail Centre
Perth Children's Hospital
Perth
Princess Margaret Hospital for Children
Perth
Sydney Children's Hospital
Randwick
Queensland Children's Hospital
South Brisbane
The Children's Hospital at Westmead
Westmead
Canada
Alberta Children's Hospital
Calgary
University of Alberta Hospital
Edmonton
IWK Health Centre
Halifax
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton
Kingston Health Sciences Centre
Kingston
Children's Hospital
London
Centre Hospitalier Universitaire Sainte-Justine
Montreal
The Montreal Children's Hospital of the MUHC
Montreal
Children's Hospital of Eastern Ontario
Ottawa
Centre Hospitalier Universitaire de Quebec
Quebec
Janeway Child Health Centre
Saint John's
Jim Pattison Children's Hospital
Saskatoon
Saskatoon Cancer Centre
Saskatoon
Hospital for Sick Children
Toronto
British Columbia Children's Hospital
Vancouver
CancerCare Manitoba
Winnipeg
New Zealand
Christchurch Hospital
Christchurch
Starship Children's Hospital
Grafton
Puerto Rico
HIMA San Pablo Oncologic Hospital
Caguas
San Jorge Children's Hospital
San Juan
University Pediatric Hospital
San Juan
Time Frame
Start Date: May 23, 2016
Completion Date: March 31, 2025
Participants
Target number of participants: 397
Treatments
Experimental: Regimen A (VAC/VI)
Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Experimental: Regimen B (VAC/VI/temsirolimus)
Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Experimental: Regimen C (FOXO1 fusion negative, VAC/VA)
Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Authors
Samuel O. Anim, Craig Erker, Lisa L. Hartman, Angela R. Girvin, Hamayun Imran, Benjamin B. Bridges, Carola A. Arndt, Winston W. Huh, Elyssa M. Rubin, Robin Y. Dulman, Haydar A. Frangoul, Frederick S. Huang, Zhihong J. Wang, David O. Walterhouse, Nina S. Kadan-Lottick, Alissa Kahn, Matthew Campbell, Kathryn L. Laurie, Marcio H. Malogolowkin, Jessica C. Hochberg, Douglas S. Hawkins, Mary L. Schmidt, Eduard H. Panosyan, Vinod K. Gidvani-Diaz, Julio C. Barredo, Vlad C. Radulescu, Matthew A. Kutny, Eric J. Lowe, Gary D. Crouch, Nadine P. SantaCruz, Mariko Sato, Caroline Y. Hu, Jessica Boklan, Keith J. August, Chana L. Glasser, Kishor M. Bhende, Howland E. Crosswell, Lisa Gennarini, Stanton C. Goldman, Sushmita Nair, Michael S. Isakoff, Kenneth G. Lucas, John J. Letterio, Justine M. Kahn, Kayelyn J. Wagner, Mukund G. Dole, Michael J. Kelly, Scott H. Maurer, David L. Becton, Laura E. Agresta, Adit L. Tal, Lars M. Wagner, Phillip E. Barnette, Matthew Dietz, Rabi Hanna, Hardeo K. Panchoosingh, Timothy C. Griffin, Robin D. Hanson, Vonda L. Crouse, Vincent F. Giusti, Scott C. Borinstein, Juan F. Rico, Ranjan Bista, Doured Daghistani, Don E. Eslin, William B. Slayton, Alyssa T. Reddy, Lolie C. Yu, Mark J. Mogul, Kamnesh R. Pradhan, Kathryn S. Sutton, Iftikhar Hanif, Xiaxin Li, Aron Flagg, Joseph G. Pressey, Holly E. Pariury, Mark A. Ranalli, David S. Dickens, Pooja Hingorani, Leonard H. Wexler, Erin K. Barr, William C. Petersen, Leo Mascarenhas, Peri Kamalakar, Jamie M. Aye, Ray C. Pais, Laura E. Hogan, Jamie L. Dargart, Nibal A. Zaghloul, Sheri L. Spunt, Adonis N. Lorenzana, Jason Law, Duncan S. Stearns, Paul M. Barr, Andrew L. Pendleton, Natalie B. Collins, Bethany G. Sleckman, Shelton A. Viola, Renuka Gera, Barbara A. Gruner, Yoko T. Udaka, Manoo G. Bhakta, Susan L. Cohn, Joseph C. Torkildson, Linda C. Stork, Michelle A. Manalang, Clare J. Twist, Craig Lotterman, Erlyn C. Smith, Aniket Saha, Maria E. Echevarria, Nkechi Onwuzurike, Colleen H. McDonough, Noah C. Federman, Eugenia Chang, Jocelyn A. Lewis, Sandeep Batra, Suman Malempati, Aghiad Chamdin, Emily G. Greengard, Thomas B. Russell, Victor A. Lewis, Naomi J. Balamuth, Mehmet F. Okcu, Yi Zeng, Meghann P. McManus, Christine A. Pratilas, Richard A. Drachtman, Nicholas W. McGregor, Alan C. Homans, James T. Badgett, Robert G. Irwin, Carla B. Golden, Roland L. Chu, Douglas J. Scothorn, Andrew A. Martin, Eugene Suh, Jonathan L. Metts, Aaron R. Weiss, Fouad M. Hajjar, Judy L. Felgenhauer, Jacob A. Troutman, Minnie Abromowitch, Michael J. McManus, Wade T. Kyono, Amy A. Smith, William D. Roberts, Bethany M. Mikles, Mahmut Y. Celiker, Gregory P. Brandt, William S. Ferguson, Marshall A. Schorin, Scott M. Bradfield, Lisa M. McGregor, Robert M. Cooper, Robert E. Goldsby, Nichole L. Bryant, Santosh S. Hanmod, Wendy L. Woods-Swafford, Susan G. Kreissman, Steven K. Bergstrom, Lauren A. Nicholls, Sara Chaffee, Laura A. Campbell, Jennifer J. Welch, Jagadeesh Ramdas, Philip M. Monteleone, Stuart L. Cramer, Andrea R. Whitfield, Jeffrey A. Toretsky, Jay Michael S. Balagtas, Joel A. Kaplan, Guy H. Grayson, Gregory E. Halligan, Bassem I. Razzouk, Brenda J. Wittman, Dan S. Zuckerman, Yung S. Yim, Samuel J. Milanovich, Katharine Offer, Alan K. Ikeda, Samantha L. Mallory, Enrique A. Escalon, Dana A. Obzut, Nkechi I. Mba, Janice F. Olson, Laura K. Gowans, Rebecca E. McFall, Narayana Gowda, Michael K. Richards, Steven J. Kuerbitz, Meghen B. Browning, Kerry K. McGowan, Alice Lee, Lauren R. Weintraub, Mark E. Weinblatt, Jeffrey H. Schwartz, Jason M. Fixler, Sharon L. Gardner, Jennifer J. Clark, Julie Kim, Jessica A. Bell, Teena Bhatla, Teresa A. York, Jessica L. Heath, Albert Kheradpour, Jeffrey S. Dome, Melissa A. Forouhar, Patrick J. Leavey, Mohamad H. Badawi, Pillai Pallavi Madhusoodhan, Steven L. Halpern, Stefanie R. Lowas, Melissa S. Singer, Farzana Pashankar, John J. Gregory, Arun A. Rangaswami, Katherine A. Janeway, Lydia A. Boateng, Emad K. Salman, Stuart H. Gold, Amy C. Fowler, Michael B. Harris, Luis A. Clavell, Douglas R. Strother, Jhon A. Guerra, Kenneth B. De Santes, Felipe S. Bautista-Otanez, Christopher P. Keuker, Tanya R. Brown, Stephan R. Paul, Christopher Mpofu, Elizabeth L. Hesketh, Karen S. Fernandez, Rebecca O. Clark, Timothy P. Garrington, Kathleen Felton, Ashley Chopek, Lisa A. Goodyear, Sharon B. Abish, Carolyn F. Levy, Mark A. Winstanley, Laura Wheaton, Ayman A. El-Sheikh, Carol A. Portwine, Yvan Samson, Anne-Marie R. Langevin, Donna L. Johnston, David B. Dix, Pedro A. De Alarcon, Shannon M. Cohn, Najat C. Daw, Tristan Pettit, Kenneth B. DeSantes, Uma H. Athale, Abha Gupta, Jacqueline M. Kraveka, Yousif (Joe) H. Matloub, Jennifer J. Greene Welch, Shayna M. Zelcer, Rene Y. McNall-Knapp, David E. Kram, Kathleen J. Yost, Jaime M. Libes, Marianne B. Phillips, Draga Barbaric, Samer Zaid Kaylani, Mohamad M. Al-Rahawan, Hector M. Rodriguez-Cortes, Mariana P. Silva, Rama Jasty, Sarah J. McKillop, Sarah E. Leary, Geoff D. Cuvelier, Anderson (Andy) B. Collier, Bruno Michon, Conrad V. Fernandez, Kenneth Lieuw
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials