Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years

Who is this study for? Patients with Ependymoma
Status: Active_not_recruiting
Location: See all (209) locations...
Intervention Type: Drug, Radiation, Biological, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The primary aim of this randomized phase III trial was to study whether the addition of maintenance chemotherapy delivered after surgical resection and focal radiation would be better than surgery and focal radiation alone. The trial also studied if patients who received induction chemotherapy and then either achieved a complete response or went on to have a complete resection would also benefit from maintenance chemotherapy. Children ages 1-21 years with newly diagnosed intracranial ependymoma were included. There were 2 arms that were not randomized. One arm studied patients with Grade II tumors located in the supratentorial compartment that were completely resected. One arm studied patients with residual tumor and those patients all received maintenance chemotherapy after focal radiation. Chemotherapy drugs, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy in combination with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 21
Healthy Volunteers: f
View:

• Patients must be newly diagnosed with histologically confirmed intracranial ependymoma; patients with classic ependymoma (WHO II) or anaplastic ependymoma (WHO III) are eligible, as are various subtypes described as clear cell, papillary, cellular or a combination of the above

• There is no minimum performance level; children with ependymoma may suffer neurologic sequelae as a result of their tumor or surgical measures taken to establish a diagnosis and resect the tumor; in the majority of cases, there is neurologic recovery; neurologic recovery is not likely to be impeded by protocol therapy

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

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

Locations
United States
Alabama
Children's Hospital of Alabama
Birmingham
University of Alabama at Birmingham Cancer Center
Birmingham
Arkansas
Arkansas Children's Hospital
Little Rock
University of Arkansas for Medical Sciences
Little Rock
Arizona
Banner Children's at Desert
Mesa
Phoenix Childrens Hospital
Phoenix
Banner University Medical Center - Tucson
Tucson
California
Kaiser Permanente Downey Medical Center
Downey
City of Hope Comprehensive Cancer Center
Duarte
Loma Linda University Medical Center
Loma Linda
Miller Children's and Women's Hospital Long Beach
Long Beach
Cedars Sinai Medical Center
Los Angeles
Children's Hospital Los Angeles
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
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
Rady Children's Hospital - San Diego
San Diego
UCSF Medical Center-Mission Bay
San Francisco
UCSF Medical Center-Parnassus
San Francisco
Colorado
Children's Hospital Colorado
Aurora
Connecticut
Connecticut Children's Medical Center
Hartford
Yale University
New Haven
Washington, D.c.
Children's National Medical Center
Washington D.c.
MedStar Georgetown University Hospital
Washington D.c.
Delaware
Alfred I duPont Hospital for Children
Wilmington
Florida
Broward Health Medical Center
Fort Lauderdale
Golisano Children's Hospital of Southwest Florida
Fort Myers
Lee Memorial Health System
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
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 Clinic - Orlando
Orlando
Nemours Children's Hospital
Orlando
Orlando Health Cancer Institute
Orlando
Nemours Children's Clinic - Pensacola
Pensacola
Johns Hopkins All Children's Hospital
St. Petersburg
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa
Saint Mary's Hospital
West Palm Beach
Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta
Augusta University Medical Center
Augusta
Memorial Health University Medical Center
Savannah
Hawaii
Kapiolani Medical Center for Women and Children
Honolulu
Iowa
Blank Children's Hospital
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Idaho
Saint Luke's Cancer Institute - Boise
Boise
Illinois
Lurie Children's Hospital-Chicago
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
Saint Jude Midwest Affiliate
Peoria
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
Tulane University Health Sciences Center
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Boston
Massachusetts General Hospital Cancer Center
Boston
Tufts Children's Hospital
Boston
Baystate Medical Center
Springfield
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
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
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
Bronson Methodist Hospital
Kalamazoo
Minnesota
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
Children's Mercy Hospitals and Clinics
Kansas City
Cardinal Glennon Children's Medical Center
St Louis
Mercy Hospital Saint Louis
St Louis
Washington University School of Medicine
St Louis
Mississippi
University of Mississippi Medical Center
Jackson
North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
Charlotte
Novant Health Presbyterian Medical Center
Charlotte
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/Dartmouth Cancer Center
Lebanon
New Jersey
Hackensack University Medical Center
Hackensack
Saint Barnabas Medical Center
Livingston
Morristown Medical Center
Morristown
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
Overlook Hospital
Summit
New Mexico
University of New Mexico Cancer Center
Albuquerque
Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas
Summerlin Hospital Medical Center
Las Vegas
Sunrise Hospital and Medical Center
Las Vegas
University Medical Center of Southern Nevada
Las Vegas
New York
Albany Medical Center
Albany
Roswell Park Cancer Institute
Buffalo
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
State University of New York Upstate Medical University
Syracuse
Montefiore Medical Center - Moses Campus
The Bronx
New York Medical College
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
Mercy Children's Hospital
Toledo
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Legacy Emanuel Children's Hospital
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
Medical University of South Carolina
Charleston
Prisma Health Richland Hospital
Columbia
BI-LO Charities Children's Cancer Center
Greenville
Greenville Cancer Treatment Center
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
T C Thompson Children's Hospital
Chattanooga
East Tennessee Childrens Hospital
Knoxville
Saint Jude Children's Research Hospital
Memphis
The Children's Hospital at TriStar Centennial
Nashville
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
Dell Children's Medical Center of Central Texas
Austin
Driscoll Children's Hospital
Corpus Christi
Medical City Dallas Hospital
Dallas
Cook Children's Medical Center
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston
Covenant Children's Hospital
Lubbock
UMC Cancer Center / UMC Health System
Lubbock
Children's Hospital of San Antonio
San Antonio
Methodist Children's Hospital of South Texas
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
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
Carilion Children's
Roanoke
Vermont
University of Vermont and State Agricultural College
Burlington
Washington
Seattle Children's Hospital
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
Spokane
Madigan Army Medical Center
Tacoma
Mary Bridge Children's Hospital and Health Center
Tacoma
Wisconsin
Saint Vincent Hospital Cancer Center Green Bay
Green Bay
University of Wisconsin Carbone Cancer Center
Madison
Marshfield Medical Center-Marshfield
Marshfield
Children's Hospital of Wisconsin
Milwaukee
West Virginia
West Virginia University Charleston Division
Charleston
West Virginia University Healthcare
Morgantown
Other Locations
Australia
Monash Medical Center-Clayton Campus
Clayton
Royal Brisbane and Women's Hospital
Herston
Royal Children's Hospital-Brisbane
Herston
John Hunter Children's Hospital
Hunter Regional Mail Centre
Women's and Children's Hospital-Adelaide
North Adelaide
Royal Children's Hospital
Parkville
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
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec
Saskatoon Cancer Centre
Saskatoon
Janeway Child Health Centre
St. John's
Hospital for Sick Children
Toronto
British Columbia Children's Hospital
Vancouver
CancerCare Manitoba
Winnipeg
New Zealand
Christchurch Hospital
Christchurch
Starship Children's Hospital
Grafton
Time Frame
Start Date: 2010-05-07
Completion Date: 2026-03-31
Participants
Target number of participants: 479
Treatments
Experimental: Arm I (chemotherapy, observation)
Patients with classic histology(WHO Grade II) supratentorial ependymoma who have undergone microscopic gross total resection (GTR1) or achieved CR either after first or second resection or after post-operative induction chemotherapy are assigned to observation. For patients without GTR1, induction chemotherapy is comprised of vincristine intravenously (IV) over 1 minute on days 1 and 8 of cycles 1 and 2, carboplatin IV over 15-60 minutes on day 1 of cycles 1 and 2, and cyclophosphamide IV over 30-60 minutes on days 1-2 of cycle 1 only. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of cycle 2 only. Cycle 1 continues for 3 weeks and cycle 2 continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (radiotherapy, chemotherapy)
Patients with supratentorial ependymoma (Grade II without GTR1 or Grade III) or any infratentorial ependymoma who have undergone gross or near total resection (GTR or NTR) or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks followed by maintenance chemotherapy. Maintenance chemotherapy comprised of vincristine IV on days 1, 8, and 15 of cycles 1-3 only, etoposide IV over 60-120 minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60 minutes on days 2-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without GTR or NTR at enrollment require induction chemotherapy (see Arm I) and possibly second surgery before randomization.
Active_comparator: Arm III (radiotherapy, observation)
Patients with supratentorial ependymoma (Grade II without GTR1 or ST Grade III) or any infratentorial ependymoma (Grade II or III) who have undergone gross or near total resection or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks and then undergo observation. Patients without GTR or NTR at enrollment require induction chemotherapy (see Arm I) and possibly second surgery before randomization.
Active_comparator: ARM IV (radiotherapy, chemotherapy)
Patients with subtotal resection after induction chemotherapy (see Arm I) and second surgery are nonrandomly assigned to Arm II treatment.
Authors
Violet Shen, Angela R. Girvin, John F. Kuttesch, Jaime Estrada, Jeffrey C. Allen, Mandy M. Atkinson, Kenneth J. Cohen, Elyssa M. Rubin, Haydar A. Frangoul, Neyssa M. Marina, Zhihong J. Wang, Ashley E. Meyer, David O. Walterhouse, Nina S. Kadan-Lottick, Alissa Kahn, Corina E. Gonzalez, Marcio H. Malogolowkin, Jessica C. Hochberg, Anna B. Pawlowska, Mehmet F. Ozkaynak, Douglas S. Hawkins, Vinod K. Gidvani-Diaz, Julio C. Barredo, Matthew A. Kutny, Rene Y. McNall-Knapp, John P. Perentesis, Eric J. Lowe, Mary L. Schmidt, Karol H. Kerr, Nadine P. SantaCruz, Mariko Sato, Stacey Rifkin-Zenenberg, Ashok B. Raj, Ricarchito B. Manera, Ronnie W. Neuberg, Jeffrey C. Murray, Anne B. Warwick, Jessica Boklan, Christopher N. Frantz, Keith J. August, Susan N. Chi, Kishor M. Bhende, Arthur K. Ritchey, Stacie L. Stapleton, Lisa Gennarini, Stanton C. Goldman, Michael S. Isakoff, John J. Letterio, Kayelyn J. Wagner, Joel A. Kaplan, Phillip E. Barnette, David H. Ebb, Howard M. Katzenstein, Rabi Hanna, Hardeo K. Panchoosingh, Timothy C. Griffin, Vincent F. Giusti, Nicholas K. Foreman, Andrew W. Walter, Don E. Eslin, William B. Slayton, Lolie C. Yu, Mark J. Mogul, Kamnesh R. Pradhan, Susumu Inoue, Iftikhar Hanif, Aron Flagg, Catherine A. Long, Mark A. Ranalli, Jane E. Minturn, Felipe S. Bautista-Otanez, Leo Mascarenhas, Peri Kamalakar, Ray C. Pais, Jamie L. Dargart, Nibal A. Zaghloul, Sheri L. Spunt, Adonis N. Lorenzana, Andrew L. Pendleton, Barbara A. Gruner, Paulette C. Bryant, Amanda M. Termuhlen, Manoo G. Bhakta, Joseph C. Torkildson, Tobey J. MacDonald, Michelle A. Manalang, Clare J. Twist, Craig Lotterman, Burton E. Appel, Colleen H. McDonough, Hector M. Rodriguez-Cortes, Salvatore J. Bertolone, Hadi Sawaf, Aghiad Chamdin, Thomas B. Russell, Robert M. Cooper, John R. Hill, Richard A. Drachtman, Jessica M. Foley, Carlos Rodriguez-Galindo, Nicholas W. McGregor, Jacqueline M. Kraveka, Robert G. Irwin, Maxim Y. Yankelevich, Fouad M. Hajjar, Carl Lenarsky, Judy L. Felgenhauer, Christopher L. Moertel, Minnie Abromowitch, Wade T. Kyono, Jeffrey A. Knipstein, Robert J. Fallon, Bethany M. Mikles, Murali M. Chintagumpala, Gregory P. Brandt, Gregory A. Hale, Ramamoorthy Nagasubramanian, Martin L. Brecher, William S. Ferguson, Marshall A. Schorin, Lisa M. McGregor, Nichole L. Bryant, Wendy L. Woods-Swafford, Steven K. Bergstrom, Sara Chaffee, Jagadeesh Ramdas, Philip M. Monteleone, Stuart L. Cramer, Jeffrey A. Toretsky, Guy H. Grayson, Gregory E. Halligan, Bassem I. Razzouk, Maryam Fouladi, Peter F. Coccia, Yung S. Yim, Emmett H. Broxson, Allen R. Chauvenet, Patricia L. Robertson, Asadullah Khan, Alan K. Ikeda, Adam J. Esbenshade, Samantha L. Mallory, Enrique A. Escalon, Dana A. Obzut, Sharad N. Salvi, Nkechi I. Mba, Janice F. Olson, Rebecca E. McFall, Howard J. Weinstein, Michael K. Richards, Wayne L. Furman, Steven J. Kuerbitz, Wendy S. Darlington, Katharina E. Elliott, Koh B. Boayue, Jeffrey H. Schwartz, Lauren R. Weintraub, Sharon K. Lockhart, Mark E. Weinblatt, Sharon L. Gardner, Clifford A. Selsky, Betty L. Herrington, Mary A. Bonilla, Peter D. Cole, Jonathan Bernstein, Jessica A. Bell, Teresa A. York, Jessica L. Heath, Jeffrey S. Dome, Melissa A. Forouhar, Eric S. Sandler, Maxine L. Hetherington, Peter G. Steinherz, Pillai Pallavi Madhusoodhan, Steven L. Halpern, Bruce C. Bostrom, Derek R. Hanson, Kelly W. Maloney, Emad K. Salman, Jeffrey R. Geyer, Stuart H. Gold, Rochelle A. Yanofsky, Eugene Suh, Vlad C. Radulescu, David L. Becton, Eugenia Chang, Lisa R. Hackney, Albert Kheradpour, Samuel O. Anim, Bethany G. Sleckman, Anuradha Banerjee, Mark P. Atlas, Lisa A. Goodyear, David S. Dickens, Alyssa T. Reddy, Yvan Samson, Douglas R. Strother, Vonda L. Crouse, Narayana Gowda, Sharon B. Abish, Lochie R. Teague, Shayna M. Zelcer, Maria L. Kirby, Stephen J. Laughton, Sarah J. McKillop, Bhavna Padhye, Geoffrey B. McCowage, Caron Strahlendorf, Timothy E. Hassall, Francoise M. Mechinaud, Donna L. Johnston, Marianne B. Phillips, Carol Portwine, Draga Barbaric, Bruno Michon, Conrad V. Fernandez, Uri Tabori, David B. Dix, Helen Irving
Related Therapeutic Areas
Sponsors
Leads: Children's Oncology Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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