Chemotherapy and Radiation Therapy in Treating Young Patients with Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma

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Status: Active

Description

This randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, 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. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed, previously untreated: (1) M0 medulloblastoma with > 1.5 cm^2 residual; (2) M+ medulloblastoma; patients with diffusely anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor * As of amendment # 2, enrollment of patients with supratentorial PNET has been discontinued * All patients with M4 disease are not eligible
  • A pre-operative magnetic resonance imaging (MRI) scan of the brain with and without contrast is required; NOTE: computed tomography (CT) scans are NOT sufficient for study eligibility * Post-operative head MRI scan with and without contrast (preferably within 72 hours post-surgery); for patients who undergo stereotactic biopsy only, either a pre or post-operative MRI is sufficient; for patients with M2 and M3 disease, a post-op MRI is strongly encouraged, but not mandatory * Spinal MRI imaging with and without gadolinium is required within 10 days of surgery if done pre-operatively or within 28 days of surgery if done post-operatively; for posterior fossa tumors, pre-operative MRI scans are preferred
  • Lumbar cerebrospinal fluid (CSF) cytology examination must be obtained pre-operatively or within 31 days following surgery; the optimal time for obtaining CSF is prior to surgery or 1-3 weeks following surgery; ventricular CSF (either pre- or post-op) may be used only if a post-operative spinal tap is contraindicated; if a spinal tap is contraindicated and there is no ventricular CSF available, then CSF cytology can be waived for patients with supratentorial tumors or if there is documentation of spinal subarachnoid metastases (M3); patients who are categorized as M1 must have either an intra-operative positive CSF (via lumbar puncture at the end of the procedure) or a positive lumbar CSF obtained > 7 days post-operatively
  • Patients must have a Karnofsky performance level of >= 30 for patients > 16 years of age or a Lansky performance scale of >= 30 for patients =< 16 years of age and life expectancy > 8 weeks
  • No previous chemotherapy or radiation therapy
  • Corticosteroids should not be used during chemotherapy administration as an antiemetic
  • Selected strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (cytochrome P450 3A4) include azole antifungals, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and St. John’s wort; the use of these drugs should be avoided with vincristine (vincristine sulfate)
  • CYP450 3A4 stimulators or inhibitors should be avoided or used with great caution when taking cyclophosphamide; aprepitant should also be used with caution with etoposide or vincristine chemotherapy
  • Cisplatin should be used with caution with nephrotoxic drug; aminoglycoside should be avoided or used with caution during or shortly after cisplatin administration and concomitant use with amphotericin B should probably also be avoided; patients receiving cisplatin and other potentially ototoxic drugs such as aminoglycoside or loop diuretics concomitantly should be closely monitored for signs of ototoxicity * Plasma levels of anticonvulsant agents should be monitored and doses adjusted during therapy with cisplatin
  • No other experimental therapy is permitted while on study
  • 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: * 0.8 mg/dL (2 to < 6 years of age) * 1.0 mg/dL (6 to < 10 years of age) * 1.2 mg/dL (10 to < 13 years of age) * 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age) * 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)
  • 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]) < 2.5 x upper limit of normal (ULN) for age; for patients on anti-seizure medications, SGOT (AST) or SGPT (ALT) must be < 5 x ULN
  • Absolute neutrophil count (ANC) >= 1,000/uL
  • Platelets >= 100,000/uL (untransfused)
  • Hemoglobin >= 8 g/dl (may be transfused)
  • Female patients who are post-menarchal must have a negative pregnancy test; lactating female patients must agree not to breast-feed while on this trial; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • 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 & Contacts

Alabama

Birmingham
Children's Hospital of Alabama
Status: Active
Contact: Alyssa Terry Reddy Email: helpdesk@childrensoncologygroup.org

Alaska

Anchorage
Providence Alaska Medical Center
Status: Active
Contact: Brenda J. Wittman
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org

Arizona

Mesa
Cardon Children's Medical Center
Status: Active
Contact: Erlyn C. Smith Email: helpdesk@childrensoncologygroup.org

Arkansas

Little Rock
Arkansas Children's Hospital
Status: Active
Contact: David L. Becton Email: helpdesk@childrensoncologygroup.org

California

Loma Linda
Loma Linda University Medical Center
Status: Active
Contact: Albert Kheradpour
Phone: 909-558-3375
Long Beach
Miller Children's and Women's Hospital Long Beach
Status: Active
Contact: Pamela Helen-Heilge Kempert Email: helpdesk@childrensoncologygroup.org
Los Angeles
Cedars Sinai Medical Center
Status: Active
Contact: Fataneh (Fae) Majlessipour
Phone: 310-423-8965
Children's Hospital Los Angeles
Status: Active
Contact: Leo Mascarenhas Email: helpdesk@childrensoncologygroup.org
Madera
Children's Hospital Central California
Status: Active
Contact: Vonda Lee Crouse Email: helpdesk@childrensoncologygroup.org
Oakland
Children's Hospital and Research Center at Oakland
Status: Active
Contact: Joseph Charles Torkildson Email: helpdesk@childrensoncologygroup.org
Kaiser Permanente-Oakland
Status: Active
Contact: Steven K. Bergstrom
Phone: 510-891-3400
Orange
Children's Hospital of Orange County
Status: Active
Contact: Elyssa M. Rubin Email: helpdesk@childrensoncologygroup.org
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Active
Contact: Sheri L Spunt Email: helpdesk@childrensoncologygroup.org
Sacramento
Sutter Medical Center Sacramento
Status: Active
Contact: Yung Soon Yim
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Marcio Henrique Malogolowkin
Phone: 916-734-3089
San Diego
Rady Children's Hospital - San Diego
Status: Active
Contact: William D. Roberts Email: helpdesk@childrensoncologygroup.org
San Francisco
UCSF Medical Center-Mission Bay
Status: Active
Contact: Anuradha Banerjee
Phone: 877-827-3222
Torrance
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Status: Active
Contact: Eduard H. Panosyan
Phone: 310-222-3621

Colorado

Aurora
Children's Hospital Colorado
Status: Active
Contact: Kathleen M. O'Toole Dorris Email: helpdesk@childrensoncologygroup.org

Connecticut

Hartford
Connecticut Children's Medical Center
Status: Active
Contact: Michael Scott Isakoff Email: helpdesk@childrensoncologygroup.org
New Haven
Yale University
Status: Active
Contact: Nina Singh Kadan-Lottick
Phone: 203-785-5702

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: Active
Contact: Andrew William Walter
Phone: 302-651-6884 Email: dperry@nemours.org

District of Columbia

Washington
Children's National Medical Center
Status: Active
Contact: Jeffrey Stuart Dome Email: helpdesk@childrensoncologygroup.org
MedStar Georgetown University Hospital
Status: Temporarily closed to accrual
Contact: Corina Elena Gonzalez
Phone: 202-444-2223

Florida

Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: Active
Contact: Emad K. Salman Email: helpdesk@childrensoncologygroup.org
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: Active
Contact: Iftikhar Hanif Email: helpdesk@childrensoncologygroup.org
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: Active
Contact: Andrew William Walter Email: helpdesk@childrensoncologygroup.org
Miami
Nicklaus Children's Hospital
Status: Active
Contact: Enrique Alberto Escalon Email: helpdesk@childrensoncologygroup.org
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Julio Cesar Barredo
Phone: 305-243-2647
Orlando
Arnold Palmer Hospital for Children
Status: Active
Contact: Vincent Ferdinando Giusti
Phone: 321-843-2584 Email: melissa.leffin@orlandohealth.com
Florida Hospital Orlando
Status: Active
Contact: Fouad M. Hajjar
Phone: 407-303-2090 Email: FH.Cancer.Research@flhosp.org
Nemours Children's Hospital
Status: Active
Contact: Andrew William Walter Email: helpdesk@childrensoncologygroup.org
Pensacola
Nemours Children's Clinic - Pensacola
Status: Active
Contact: Andrew William Walter Email: helpdesk@childrensoncologygroup.org
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: Active
Contact: Stacie Lynn Stapleton Email: helpdesk@childrensoncologygroup.org
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: Active
Contact: Mark J. Mogul
Phone: 704-384-5369
Tampa General Hospital
Status: Active
Contact: Juan Felipe Rico
Phone: 813-844-7829 Email: syapchanyk@tgh.org
West Palm Beach
Saint Mary's Hospital
Status: Active
Contact: Narayana Gowda Email: helpdesk@childrensoncologygroup.org

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: Temporarily closed to accrual
Contact: Anna Julia Janss Email: helpdesk@childrensoncologygroup.org
Savannah
Memorial University Medical Center
Status: Active
Contact: J. Martin Johnston
Phone: 912-350-7887 Email: clayter1@memorialhealth.com

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: Active
Contact: Wade T. Kyono
Phone: 808-983-6090

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Eugenia Chang Email: helpdesk@childrensoncologygroup.org

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: Active
Contact: Stewart Goldman Email: helpdesk@childrensoncologygroup.org
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Wendy Shannon Darlington
Phone: 773-834-7424
University of Illinois
Status: Active
Contact: Mary Lou Schmidt
Phone: 312-355-3046
Maywood
Loyola University Medical Center
Status: Active
Contact: Eugene Suh
Phone: 708-226-4357
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: Active
Contact: Rebecca Erin McFall Email: helpdesk@childrensoncologygroup.org
Park Ridge
Advocate Children's Hospital-Park Ridge
Status: Active
Contact: Caroline Yingwen Hu Email: helpdesk@childrensoncologygroup.org
Peoria
Saint Jude Midwest Affiliate
Status: Active
Contact: Pedro A. De Alarcon
Phone: 888-226-4343
Springfield
Southern Illinois University School of Medicine
Status: Active
Contact: Gregory P. Brandt
Phone: 217-545-7929

Indiana

Indianapolis
Riley Hospital for Children
Status: Active
Contact: Kamnesh Ratnakar Pradhan
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: Temporarily closed to accrual
Contact: Bassem I. Razzouk
Phone: 317-338-2194 Email: research@stvincent.org

Iowa

Des Moines
Blank Children's Hospital
Status: Active
Contact: Wendy Leigh Woods-Swafford Email: helpdesk@childrensoncologygroup.org
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Mariko Sato
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Lars Martin Wagner
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: Active
Contact: Ashok B. Raj
Phone: 866-530-5516

Louisiana

New Orleans
Children's Hospital New Orleans
Status: Active
Contact: Lolie C. Yu Email: helpdesk@childrensoncologygroup.org

Maine

Bangor
Eastern Maine Medical Center
Status: Active
Contact: Nadine Patricia Sauer SantaCruz
Phone: 207-973-4274

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Kenneth J. Cohen
Phone: 410-955-8804 Email: jhcccro@jhmi.edu
Bethesda
Walter Reed National Military Medical Center
Status: Active
Contact: Kenneth Lieuw
Phone: 301-319-2100

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Contact: Susan N. Chi
Phone: 877-442-3324
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Alison M. Friedmann
Phone: 877-726-5130

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: Active
Contact: Patricia L. Robertson Email: helpdesk@childrensoncologygroup.org
Detroit
Saint John Hospital and Medical Center
Status: Active
Contact: Adonis N. Lorenzana
Phone: 734-712-3671 Email: stephanie.couch@stjoeshealth.org
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Kanta Bhambhani
Phone: 313-576-9363
East Lansing
Michigan State University Clinical Center
Status: Active
Contact: Renuka Gera
Phone: 517-975-9547
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: Active
Contact: David Scott Dickens
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Kalamazoo
Bronson Methodist Hospital
Status: Active
Contact: Katharina Elisabeth Elliott
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: Active
Contact: Michael Kerr Richards Email: helpdesk@childrensoncologygroup.org
University of Minnesota / Masonic Cancer Center
Status: Active
Contact: Christopher Loren Moertel Email: helpdesk@childrensoncologygroup.org
Rochester
Mayo Clinic
Status: Active
Contact: Amulya Anakapalli Nageswara Rao
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: Active
Contact: Gail Cranshaw Megason
Phone: 601-815-6700

Missouri

Columbia
Columbia Regional
Status: Active
Contact: Barbara Anne Gruner Email: helpdesk@childrensoncologygroup.org
Kansas City
The Childrens Mercy Hospital
Status: Active
Contact: Keith Jason August Email: helpdesk@childrensoncologygroup.org
Saint Louis
Cardinal Glennon Children's Medical Center
Status: Active
Contact: William Shay Ferguson Email: helpdesk@childrensoncologygroup.org
Mercy Hospital Saint Louis
Status: Active
Contact: Bethany Graham Sleckman
Phone: 314-251-6770
Washington University School of Medicine
Status: Active
Contact: Joshua B. Rubin
Phone: 800-600-3606 Email: info@siteman.wustl.edu

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: Active
Contact: Minnie Abromowitch Email: helpdesk@childrensoncologygroup.org

Nevada

Las Vegas
Children's Specialty Center of Nevada II
Status: Active
Contact: Alan K. Ikeda Email: helpdesk@childrensoncologygroup.org
Summerlin Hospital Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013 Email: research@sncrf.org
Sunrise Hospital and Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013 Email: research@sncrf.org
University Medical Center of Southern Nevada
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013 Email: research@sncrf.org

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Sara Chaffee
Phone: 800-639-6918 Email: cancer.research.nurse@dartmouth.edu

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Contact: Derek R. Hanson
Phone: 201-996-2879
Livingston
Saint Barnabas Medical Center
Status: Temporarily closed to accrual
Contact: Stacey Rifkin-Zenenberg
Phone: 973-322-2470
Morristown
Morristown Medical Center
Status: Active
Contact: Steven Lon Halpern
Phone: 973-971-5900
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: Temporarily closed to accrual
Contact: Richard A. Drachtman
Phone: 732-235-8675
Saint Peter's University Hospital
Status: Active
Contact: Nibal Ahmad Zaghloul Email: helpdesk@childrensoncologygroup.org
Newark
Newark Beth Israel Medical Center
Status: Temporarily closed to accrual
Contact: Peri Kamalakar
Phone: 973-926-7230
Paterson
Saint Joseph's Regional Medical Center
Status: Active
Contact: Mary Ann Bonilla Email: helpdesk@childrensoncologygroup.org

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Koh B. Boayue
Phone: 505-925-0366 Email: LByatt@nmcca.org

New York

Albany
Albany Medical Center
Status: Active
Contact: Kenneth G. Lucas
Phone: 518-262-5513
Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Lisa Gennarini
Phone: 718-904-2730 Email: aecc@aecom.yu.edu
Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Lorna K. Fitzpatrick
Phone: 877-275-7724
Mineola
NYU Winthrop Hospital
Status: Active
Contact: Mark E. Weinblatt
Phone: 516-663-3115
New Hyde Park
The Steven and Alexandra Cohen Children's Medical Center of New York
Status: Active
Contact: Mark P. Atlas Email: helpdesk@childrensoncologygroup.org
New York
Columbia University / Herbert Irving Cancer Center
Status: Active
Contact: Alice Lee
Phone: 212-305-6361 Email: nr2616@cumc.columbia.edu
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Sharon Leigh Gardner
Phone: 212-263-4434 Email: prmc.coordinator@nyumc.org
Mount Sinai Hospital
Status: Active
Contact: Birte Wistinghausen
Phone: 212-824-7309 Email: CCTO@mssm.edu
Rochester
University of Rochester
Status: Active
Contact: Jeffrey Robert Andolina
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: Active
Contact: Laura Elaina Hogan
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Philip M. Monteleone
Phone: 315-464-5476

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Stuart Harrison Gold
Phone: 877-668-0683 Email: cancerclinicaltrials@med.unc.edu
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Joel A. Kaplan
Phone: 704-355-2884
Novant Health Presbyterian Medical Center
Status: Active
Contact: Jessica Amy Fu Bell
Phone: 704-384-5369 Email: nnechiporchik@novanthealth.org
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Thomas Bennett Russell
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: Active
Contact: Samuel Odame Anim
Phone: 800-437-4010

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: Active
Contact: Steven J. Kuerbitz Email: helpdesk@childrensoncologygroup.org
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: Active
Contact: Maryam Fouladi Email: helpdesk@childrensoncologygroup.org
Cleveland
Cleveland Clinic Foundation
Status: Active
Contact: Aron Flagg
Phone: 866-223-8100
Rainbow Babies and Childrens Hospital
Status: Active
Contact: Yousif (Joe) H. Matloub
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: Active
Contact: Mark Anthony Ranalli Email: helpdesk@childrensoncologygroup.org
Dayton
Dayton Children's Hospital
Status: Active
Contact: Ayman Aly El-Sheikh Email: helpdesk@childrensoncologygroup.org
Toledo
Mercy Children's Hospital
Status: Temporarily closed to accrual
Contact: Rama Jasty
Phone: 888-823-5923 Email: ctsucontact@westat.com
The Toledo Hospital / Toledo Children's Hospital
Status: Active
Contact: Jamie L. Dargart
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Rene Yvonne McNall-Knapp
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu

Oregon

Portland
Legacy Emanuel Children's Hospital
Status: Active
Contact: Janice Faye Olson Email: helpdesk@childrensoncologygroup.org
Oregon Health and Science University
Status: Active
Contact: Kellie Jean Nazemi
Phone: 503-494-1080 Email: trials@ohsu.edu

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Active
Contact: Lydia Alberta Boateng
Phone: 734-712-3671 Email: stephanie.couch@stjoeshealth.org
Danville
Geisinger Medical Center
Status: Active
Contact: Jagadeesh Ramdas
Phone: 570-271-5251 Email: HemonCCTrials@geisinger.edu
Hershey
Penn State Children's Hospital
Status: Active
Contact: Lisa MacNabb McGregor Email: helpdesk@childrensoncologygroup.org
Philadelphia
Children's Hospital of Philadelphia
Status: Active
Contact: Michael J. Fisher Email: helpdesk@childrensoncologygroup.org
Saint Christopher's Hospital for Children
Status: Active
Contact: Gregory Emmett Halligan Email: helpdesk@childrensoncologygroup.org
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Active
Contact: Jean M. Tersak Email: helpdesk@childrensoncologygroup.org

Puerto Rico

San Juan
University Pediatric Hospital
Status: Active
Contact: Luis A. Clavell
Phone: 787-474-0333

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: Jacqueline M. Kraveka
Phone: 843-792-9321 Email: hcc-clinical-trials@musc.edu
Columbia
Palmetto Health Richland
Status: Active
Contact: Stuart Louis Cramer
Phone: 803-434-3680
Greenville
BI-LO Charities Children's Cancer Center
Status: Active
Contact: Nichole Leigh Bryant Email: helpdesk@childrensoncologygroup.org

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Kayelyn Jean Wagner
Phone: 605-312-3320 Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Chattanooga
T C Thompson Children's Hospital
Status: Active
Contact: Manoo G. Bhakta Email: helpdesk@childrensoncologygroup.org
Knoxville
East Tennessee Childrens Hospital
Status: Active
Contact: Ray C. Pais
Phone: 865-541-8266
Nashville
The Children's Hospital at TriStar Centennial
Status: Active
Contact: Haydar A. Frangoul Email: helpdesk@childrensoncologygroup.org
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Devang J Pastakia
Phone: 800-811-8480

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: Active
Contact: Amy Catherine Fowler Email: helpdesk@childrensoncologygroup.org
Corpus Christi
Driscoll Children's Hospital
Status: Active
Contact: Nkechi Ifeoma Mba Email: helpdesk@childrensoncologygroup.org
Dallas
Medical City Dallas Hospital
Status: Active
Contact: Stanton Carl Goldman
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Daniel Charles Bowers
Phone: 214-648-7097
Fort Worth
Cook Children's Medical Center
Status: Active
Contact: Jeffrey Carlton Murray Email: helpdesk@childrensoncologygroup.org
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Active
Contact: Murali Mohan Chintagumpala
Phone: 713-798-1354 Email: burton@bcm.edu
M D Anderson Cancer Center
Status: Active
Contact: Soumen Khatua
Phone: 713-792-3245
Lubbock
Covenant Children's Hospital
Status: Active
Contact: Kishor Mallikarjun Bhende Email: helpdesk@childrensoncologygroup.org
University Medical Center
Status: Active
Contact: Mohamad M. Al-Rahawan Email: helpdesk@childrensoncologygroup.org
San Antonio
Children's Hospital of San Antonio
Status: Active
Contact: Timothy C. Griffin Email: helpdesk@childrensoncologygroup.org
Methodist Children's Hospital of South Texas
Status: Active
Contact: Vinod Kumar Gidvani-Diaz Email: helpdesk@childrensoncologygroup.org
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Anne-Marie R. Langevin
Phone: 210-450-3800 Email: CTO@uthscsa.edu
Temple
Scott and White Memorial Hospital
Status: Temporarily closed to accrual
Contact: Guy Howard Grayson
Phone: 254-724-5407

Utah

Salt Lake City
Primary Children's Hospital
Status: Active
Contact: Phillip Evan Barnette Email: helpdesk@childrensoncologygroup.org

Vermont

Burlington
University of Vermont College of Medicine
Status: Active
Contact: Alan Charles Homans
Phone: 802-656-8990

Virginia

Falls Church
Inova Fairfax Hospital
Status: Active
Contact: Marshall A. Schorin
Phone: 703-208-6650 Email: Stephanie.VanBebber@inova.org
Norfolk
Childrens Hospital-King's Daughters
Status: Active
Contact: Eric Jeffrey Lowe Email: helpdesk@childrensoncologygroup.org
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Active
Contact: Seth Joel Corey Email: mwellons@vcu.edu
Roanoke
Carilion Clinic Children's Hospital
Status: Active
Contact: Mandy M Atkinson Email: helpdesk@childrensoncologygroup.org

Washington

Seattle
Seattle Children's Hospital
Status: Active
Contact: Douglas S. Hawkins Email: helpdesk@childrensoncologygroup.org
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: Active
Contact: Judy L. Felgenhauer Email: helpdesk@childrensoncologygroup.org
Tacoma
Madigan Army Medical Center
Status: Active
Contact: Melissa Anne Forouhar
Phone: 253-968-0129 Email: mamcdci@amedd.army.mil
Mary Bridge Children's Hospital and Health Center
Status: Active
Contact: Robert G. Irwin Email: helpdesk@childrensoncologygroup.org

West Virginia

Charleston
West Virginia University Charleston
Status: Active
Contact: Ashley E. Meyer
Phone: 304-388-9944
Morgantown
West Virginia University Healthcare
Status: Active
Contact: Stephan R. Paul
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: John Robert Hill
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Marshfield
Marshfield Clinic
Status: Active
Contact: Michael John McManus
Phone: 800-782-8581 Email: oncology.clinical.trials@marshfieldresearch.org
Milwaukee
Children's Hospital of Wisconsin
Status: Active
Contact: Jeffrey Alan Knipstein
Phone: 414-955-4727 Email: MACCCTO@mcw.edu

Alberta

Edmonton
University of Alberta Hospital
Status: Active
Contact: Sarah Jane McKillop
Phone: 780-407-6615 Email: val.taylor@albertahealthservices.ca

British Columbia

Vancouver
British Columbia Children's Hospital
Status: Active
Contact: David Bryan Dix Email: helpdesk@childrensoncologygroup.org

Manitoba

Winnipeg
CancerCare Manitoba
Status: Active
Contact: Tanya Renae Brown
Phone: 306-766-2213

Nova Scotia

Halifax
IWK Health Centre
Status: Active
Contact: Conrad Vincent Fernandez
Phone: 902-470-8394

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: Active
Contact: Carol A. Portwine Email: helpdesk@childrensoncologygroup.org
Ottawa
Children's Hospital of Eastern Ontario
Status: Active
Contact: Donna Lynn Johnston Email: helpdesk@childrensoncologygroup.org
Toronto
Hospital for Sick Children
Status: Active
Contact: Eric Bouffet
Phone: 416-813-7654ext2027 Email: jason.mcguire@sickkids.ca

Quebec

Montreal
Centre Hospitalier Universitaire Sainte-Justine
Status: Active
Contact: Yvan Samson
Phone: 514-345-4931
Quebec
Centre Hospitalier Universitaire de Quebec
Status: Active
Contact: Bruno Michon Email: helpdesk@childrensoncologygroup.org

Saskatchewan

Saskatoon
Saskatoon Cancer Centre
Status: Active
Contact: Christopher Mpofu
Phone: 306-655-2914

Australia

North Adelaide
Women's and Children's Hospital-Adelaide
Status: Active
Contact: Maria Louise Kirby Email: helpdesk@childrensoncologygroup.org
Perth
Princess Margaret Hospital for Children
Status: Active
Contact: Marianne Barnetson Phillips
Phone: (08) 9340 8222 Email: catherine.cole@health.wa.gov.au

Netherlands

Den Haag
Dutch Childhood Oncology Group
Status: Temporarily closed to accrual
Contact: Cornelia Elisabeth Maria Gidding Email: info@skion.nl

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine whether carboplatin radiosensitization increases long term event-free survival for high risk medulloblastoma/primitive neuroectodermal tumor (PNET) patients.

II. To determine whether isotretinoin increases long term event-free survival for high risk medulloblastoma/PNET patients.

SECONDARY OBJECTIVES:

I. To compare residual disease response to radiation alone versus radiation plus carboplatin.

II. To identify molecular prognostic indicators suitable for patient stratification in future trials.

III. To evaluate the health-related quality of life (HRQOL) during phases of active treatment specific to treatment modalities.

IV. To describe the neuropsychological functioning of the study population and to evaluate the relationship between neuropsychological status and health related quality of life.

OUTLINE: Patients are randomized to Arm A or Arm B (Arms C and D closed to accrual as of Amendment 3 1/27/15).

ARM A (standard chemoradiotherapy and standard maintenance therapy):

CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily (QD) five days a week for 6 weeks. Patients also receive vincristine sulfate intravenously (IV) over 1 minute once weekly for 6 weeks. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive cisplatin IV over 6 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 8, and cyclophosphamide IV over 1 hour on days 2 and 3. Patients also receive filgrastim subcutaneously (SC) or IV beginning on day 4 and continuing until blood counts recover (at least 10 days). Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

ARM B (standard chemoradiotherapy plus carboplatin and standard maintenance therapy):

CHEMORADIOTHERAPY: Patients receive vincristine sulfate and undergo radiation therapy as in Arm I. Patients also receive carboplatin IV over 15 minutes on each day of radiation therapy. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm I.

ARM C (standard chemoradiotherapy, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin - CLOSED TO ACCRUAL 1/27/15):

CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm I. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive isotretinoin orally (PO) twice daily (BID) on day 1 and days 16-28 and cisplatin, vincristine sulfate, cyclophosphamide, and filgrastim as in Arm I maintenance therapy. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to continuation therapy.

CONTINUATION THERAPY: Patients receive isotretinoin PO BID on days 15-28 every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

ARM D (standard chemoradiotherapy plus carboplatin, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin - CLOSED TO ACCRUAL 1/27/15):

CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm II. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm III. Patients then proceed to continuation therapy.

CONTINUATION THERAPY: Patients receive continuation therapy as in Arm III.

After completion of study treatment, patients are followed up periodically for 1 year.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Childrens Oncology Group

Principal Investigator
James Michael Olson

Trial IDs

Primary ID ACNS0332
Secondary IDs NCI-2009-00336, 07-271, COG-ACNS0332, CDR0000511991
Clinicaltrials.gov ID NCT00392327