Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients with Newly Diagnosed WNT-Driven Medulloblastoma

Status: Active

Description

This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT) / Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, 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 reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.

Eligibility Criteria

Inclusion Criteria

  • Patients must be newly diagnosed and have: * Eligibility confirmed by rapid central pathology and molecular screening review on APEC14B1: ** Classical histologic type (non LC/A) WNT medulloblastoma ** Positive nuclear beta-catenin by immunohistochemistry (IHC) ** Positive for CTNNB1 mutation ** Negative for MYC and MYCN by fluorescence in situ hybridization (FISH)
  • Patient must have negative lumbar cerebrospinal fluid (CSF) cytology * Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study; patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status; patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated; patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively
  • Patients must have eligibility confirmed by Rapid Central Imaging Review on APEC14B1; patients must have =< 1.5 cm^2 maximal cross-sectional area of residual tumor; whole brain magnetic resonance imaging (MRI) with and without gadolinium and spine MRI with gadolinium must be performed
  • Patients must be enrolled, and protocol therapy must be projected to begin, no later than 36 days after definitive diagnostic surgery (day 0)
  • Peripheral absolute neutrophil count (ANC) >= 1000/uL
  • Platelet count >= 100,000/uL (transfusion independent)
  • Hemoglobin >= 10.0 g/dL (may receive red blood cell [RBC] transfusions)
  • 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: * 3 to < 6 years of age: maximum (max) serum creatinine 0.8 mg/dL (males and females) * 6 to < 10 years of age: max serum creatinine 1 mg/dL (males and females) * 10 to < 13 years of age: max serum creatinine 1.2 mg/dL (males and females) * 13 to < 16 years of age: max serum creatinine 1.5 md/dL (males) and 1.4 md/dL (females) * >= 16 years of age: max serum creatinine 1.7 mg/dL (males) and 1.4 mg/dL (females) ** The threshold creatinine values were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC)
  • Total or direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
  • Serum glutamate pyruvate (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (3x ULN); for the purpose of this study, the ULN for SGPT is 45 U/L
  • Central nervous system function defined as: * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled * Patients must not be in status epilepticus, a coma or on assisted ventilation at the time of study enrollment
  • Patients must have receptive and expressive language skills in English, French, or Spanish to complete the QoL and neurocognitive assessments; if a patient meets these criteria but the parent/guardian speaks a language other than English, French, or Spanish, the patient may still be enrolled and tested, and the parent-report measures should be omitted
  • All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria

  • Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible
  • Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids
  • Pregnancy and Breast Feeding * Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies * Lactating females are not eligible unless they have agreed not to breastfeed their infants * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained * Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
  • Patients with a history of moderate to profound intellectual disability (i.e., intelligence quotient [Q)]=< 55) are not eligible for enrollment; PLEASE NOTE: Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g., dyslexia) are eligible for this study

Locations & Contacts

Alabama

Birmingham
Children's Hospital of Alabama
Status: Active
Contact: Site Public Contact
Phone: 205-638-9285
Email: oncologyresearch@peds.uab.edu

Alaska

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

Arizona

Mesa
Cardon Children's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 602-747-9738
Phoenix
Phoenix Childrens Hospital
Status: Active
Contact: Site Public Contact
Phone: 602-546-0920

Arkansas

Little Rock
Arkansas Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 501-364-7373

California

Downey
Kaiser Permanente Downey Medical Center
Status: Active
Contact: Site Public Contact
Phone: 626-564-3455
Loma Linda
Loma Linda University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 909-558-3375
Long Beach
Miller Children's and Women's Hospital Long Beach
Status: Active
Contact: Site Public Contact
Phone: 562-933-5600
Los Angeles
Cedars Sinai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 310-423-8965
Children's Hospital Los Angeles
Status: Active
Contact: Site Public Contact
Phone: 323-361-4110
Mattel Children's Hospital UCLA
Status: Active
Contact: Site Public Contact
Phone: 310-825-6708
Madera
Valley Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 559-353-3000
Email: Research@valleychildrens.org
Oakland
Children's Hospital and Research Center at Oakland
Status: Active
Contact: Site Public Contact
Phone: 510-428-3324
Email: cgolden@mail.cho.org
Kaiser Permanente-Oakland
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
Children's Hospital of Orange County
Status: Active
Contact: Site Public Contact
Phone: 714-997-3000
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Active
Contact: Site Public Contact
Phone: 800-694-0012
Email: ccto-office@stanford.edu
Sacramento
Sutter Medical Center Sacramento
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089
Torrance
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Status: Active
Contact: Site Public Contact
Phone: 310-222-3621

Colorado

Aurora
Children's Hospital Colorado
Status: Active
Contact: Site Public Contact
Phone: 303-764-5056
Email: josh.b.gordon@nsmtp.kp.org
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-839-6000

Connecticut

Hartford
Connecticut Children's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 860-545-9981

Delaware

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

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Contact: Site Public Contact
Phone: 202-444-2223

Florida

Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: Active
Contact: Site Public Contact
Phone: 239-343-5333
Email: molly.arnstrom@leehealth.org
Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: Site Public Contact
Phone: 352-273-8010
Email: cancer-center@ufl.edu
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 954-265-1847
Email: OHR@mhs.net
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: Active
Contact: Site Public Contact
Phone: 904-697-3529
Miami
Nicklaus Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 888-624-2778
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
AdventHealth Orlando
Status: Active
Contact: Site Public Contact
Phone: 407-303-2090
Email: FH.Cancer.Research@flhosp.org
Arnold Palmer Hospital for Children
Status: Active
Contact: Site Public Contact
Phone: 321-843-2584
Email: melissa.leffin@orlandohealth.com
Nemours Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 407-650-7150
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 727-767-4784
Email: Ashley.Repp@jhmi.edu
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: Active
Contact: Site Public Contact
Phone: 813-356-7168
Email: Katelynn.Colgain@baycare.org
West Palm Beach
Saint Mary's Hospital
Status: Active
Contact: Site Public Contact
Phone: 561-881-2815

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: Active
Contact: Site Public Contact
Phone: 404-785-2025
Email: Leann.Schilling@choa.org
Savannah
Memorial Health University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 912-350-7887
Email: clayter1@memorialhealth.com

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: Active
Contact: Site Public Contact
Phone: 808-983-6090

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Site Public Contact
Phone: 208-381-2774
Email: eslinget@slhs.org

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: Active
Contact: Site Public Contact
Phone: 773-880-4562
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
University of Illinois
Status: Active
Contact: Site Public Contact
Phone: 312-355-3046
Maywood
Loyola University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: Active
Contact: Site Public Contact
Phone: 847-723-7570
Park Ridge
Advocate Children's Hospital-Park Ridge
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Peoria
Saint Jude Midwest Affiliate
Status: Active
Contact: Site Public Contact
Phone: 888-226-4343
Springfield
Southern Illinois University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 217-545-7929

Indiana

Indianapolis
Riley Hospital for Children
Status: Active
Contact: Site Public Contact
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: Active
Contact: Site Public Contact
Phone: 317-338-2194
Email: research@stvincent.org

Iowa

Des Moines
Blank Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 515-241-8912
Email: samantha.mallory@unitypoint.org
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 859-257-3379

Louisiana

New Orleans
Children's Hospital New Orleans
Status: Active
Contact: Site Public Contact
Email: CHResearch@lcmchealth.org
Ochsner Medical Center Jefferson
Status: Active
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org

Maine

Bangor
Eastern Maine Medical Center
Status: Active
Contact: Site Public Contact
Phone: 207-973-4274
Scarborough
Maine Children's Cancer Program
Status: Active
Contact: Site Public Contact
Phone: 207-396-7581
Email: sverwys@mmc.org

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 877-442-3324
Floating Hospital for Children at Tufts Medical Center
Status: Active
Contact: Site Public Contact
Phone: 617-636-5535
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-726-5130
Worcester
University of Massachusetts Medical School
Status: Active
Contact: Site Public Contact
Phone: 508-856-3216
Email: cancer.research@umassmed.edu

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Detroit
Ascension Saint John Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
East Lansing
Michigan State University Clinical Center
Status: Active
Contact: Site Public Contact
Phone: 517-975-9547
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Spectrum Health at Butterworth Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Kalamazoo
Bronson Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
West Michigan Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Royal Oak
Beaumont Children's Hospital-Royal Oak
Status: Active
Contact: Site Public Contact
Phone: 248-551-7695

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 612-624-2620
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: Active
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Columbia
Columbia Regional
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Kansas City
Children's Mercy Hospitals and Clinics
Status: Active
Contact: Site Public Contact
Phone: 816-302-6808
Email: rryan@cmh.edu
Saint Louis
Cardinal Glennon Children's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 314-268-4000
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-7066
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: Active
Contact: Site Public Contact
Phone: 402-955-3949
University of Nebraska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 402-559-6941
Email: unmcrsa@unmc.edu

Nevada

Las Vegas
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Summerlin Hospital Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
University Medical Center of Southern Nevada
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org

New Hampshire

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

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 201-996-2879
Morristown
Morristown Medical Center
Status: Active
Contact: Site Public Contact
Phone: 973-971-5900
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: Active
Contact: Site Public Contact
Phone: 732-235-8675
Saint Peter's University Hospital
Status: Active
Contact: Site Public Contact
Phone: 732-745-8600ext6163
Email: kcovert@saintpetersuh.com
Newark
Newark Beth Israel Medical Center
Status: Active
Contact: Site Public Contact
Phone: 973-926-7230
Paterson
Saint Joseph's Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 973-754-2207
Email: HallL@sjhmc.org

New York

Albany
Albany Medical Center
Status: Active
Contact: Site Public Contact
Phone: 518-262-5513
Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
Mineola
NYU Winthrop Hospital
Status: Active
Contact: Site Public Contact
Phone: 516-663-3115
New Hyde Park
The Steven and Alexandra Cohen Children's Medical Center of New York
Status: Active
Contact: Site Public Contact
Phone: 718-470-3460
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
Mount Sinai Hospital
Status: Active
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Site Public Contact
Phone: 315-464-5476
Valhalla
New York Medical College
Status: Active
Contact: Site Public Contact
Phone: 914-594-3794

North Carolina

Asheville
Mission Hospital Inc-Memorial Campus
Status: Active
Contact: Site Public Contact
Phone: 828-213-4150
Email: leslie.verner@msj.org
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Novant Health Presbyterian Medical Center
Status: Active
Contact: Site Public Contact
Phone: 704-384-5369
Email: nnechiporchik@novanthealth.org
Greenville
East Carolina University
Status: Active
Contact: Site Public Contact
Phone: 252-744-1015
Email: eubankss@ecu.edu
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: Active
Contact: Site Public Contact
Phone: 330-543-3193
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: Active
Contact: Site Public Contact
Phone: 513-636-2799
Email: cancer@cchmc.org
Cleveland
Cleveland Clinic Foundation
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Rainbow Babies and Childrens Hospital
Status: Active
Contact: Site Public Contact
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-072-2657
Email: amy.yekisa@nationwidechildrens.org
Dayton
Dayton Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-228-4055
Toledo
The Toledo Hospital / Toledo Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842

Oklahoma

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

Oregon

Portland
Legacy Emanuel Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 503-413-2560
Oregon Health and Science University
Status: Active
Contact: Site Public Contact
Phone: 503-494-1080
Email: trials@ohsu.edu

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Danville
Geisinger Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Hershey
Penn State Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 717-531-6012
Philadelphia
Children's Hospital of Philadelphia
Status: Active
Contact: Site Public Contact
Phone: 267-425-5544
Email: CancerTrials@email.chop.edu
Saint Christopher's Hospital for Children
Status: Active
Contact: Site Public Contact
Phone: 215-427-8991
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Active
Contact: Site Public Contact
Phone: 412-692-8570
Email: jean.tersak@chp.edu

Puerto Rico

Caguas
HIMA San Pablo Oncologic Hospital
Status: Active
Contact: Site Public Contact
Phone: 787-653-3434

Rhode Island

Providence
Rhode Island Hospital
Status: Active
Contact: Site Public Contact
Phone: 401-444-1488

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: Site Public Contact
Phone: 843-792-9321
Email: hcc-clinical-trials@musc.edu
Columbia
Prisma Health Richland Hospital
Status: Active
Contact: Site Public Contact
Phone: 803-434-3533
Greenville
BI-LO Charities Children's Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 864-455-8898

South Dakota

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

Tennessee

Chattanooga
T C Thompson Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 865-331-1812
Knoxville
East Tennessee Childrens Hospital
Status: Active
Contact: Site Public Contact
Phone: 865-541-8266
Nashville
The Children's Hospital at TriStar Centennial
Status: Active
Contact: Site Public Contact
Phone: 615-342-1919
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: Active
Contact: Site Public Contact
Phone: 512-628-1902
Email: TXAUS-DL-SFCHemonc.research@ascension.org
Corpus Christi
Driscoll Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 361-694-5311
Email: Crystal.DeLosSantos@dchstx.org
Dallas
Medical City Dallas Hospital
Status: Active
Contact: Site Public Contact
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
El Paso
El Paso Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 915-298-5444
Email: lisa.hartman@ttuhsc.edu
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 713-798-1354
Email: burton@bcm.edu
Lubbock
Covenant Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
University Medical Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
San Antonio
Children's Hospital of San Antonio
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Methodist Children's Hospital of South Texas
Status: Active
Contact: Site Public Contact
Phone: 210-575-6240
Email: Vinod.GidvaniDiaz@hcahealthcare.com
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Site Public Contact
Phone: 210-450-3800
Email: phoresearchoffice@uthscsa.edu
Temple
Scott and White Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 254-724-5407

Utah

Salt Lake City
Primary Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 801-585-5270

Vermont

Burlington
University of Vermont and State Agricultural College
Status: Active
Contact: Site Public Contact
Phone: 802-656-8990
Email: rpo@uvm.edu

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Approved
Contact: Site Public Contact
Phone: 434-243-6303
Email: PAS9E@virginia.edu
Falls Church
Inova Fairfax Hospital
Status: Active
Contact: Site Public Contact
Phone: 703-208-6650
Email: Stephanie.VanBebber@inova.org
Norfolk
Children's Hospital of The King's Daughters
Status: Active
Contact: Site Public Contact
Phone: 757-066-8724
Email: CCBDCresearch@chkd.org
Portsmouth
Naval Medical Center - Portsmouth
Status: Active
Contact: Site Public Contact
Phone: 757-953-5939
Roanoke
Carilion Clinic Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 540-266-6238
Email: wpmccarty@carilionclinic.org

Washington

Seattle
Seattle Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 866-987-2000
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-228-6618
Email: HopeBeginsHere@providence.org
Tacoma
Mary Bridge Children's Hospital and Health Center
Status: Active
Contact: Site Public Contact
Phone: 253-403-1461
Email: research@multicare.org

West Virginia

Morgantown
West Virginia University Healthcare
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Marshfield
Marshfield Medical Center-Marshfield
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Milwaukee
Children's Hospital of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-955-4727
Email: MACCCTO@mcw.edu

British Columbia

Vancouver
British Columbia Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 604-875-2345ext6477

Manitoba

Winnipeg
CancerCare Manitoba
Status: Active
Contact: Site Public Contact
Phone: 866-561-1026
Email: ctu_web@cancercare.mb.ca

Newfoundland and Labrador

Saint John's
Janeway Child Health Centre
Status: Active
Contact: Site Public Contact
Phone: 866-722-1126

Nova Scotia

Halifax
IWK Health Centre
Status: Active
Contact: Site Public Contact
Phone: 902-470-6767

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 905-521-2100
Kingston
Kingston Health Sciences Centre
Status: Active
Contact: Site Public Contact
Phone: 613-549-6666
Email: cc-clinicaltrials@kgh.kari.net
London
Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 519-685-8306
Ottawa
Children's Hospital of Eastern Ontario
Status: Active
Contact: Site Public Contact
Phone: 613-738-3931
Toronto
Hospital for Sick Children
Status: Active
Contact: Site Public Contact
Phone: 416-813-7654ext2027
Email: jason.mcguire@sickkids.ca

Quebec

Montreal
The Montreal Children's Hospital of the MUHC
Status: Active
Contact: Site Public Contact
Phone: 514-412-4445
Email: info@thechildren.com

Saskatchewan

Saskatoon
Saskatoon Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 306-655-2914

Australia

North Adelaide
Women's and Children's Hospital-Adelaide
Status: Active
Contact: Site Public Contact
Phone: (08) 8161 7327
Email: cywhs.oncsec@health.sa.gov.au
Perth
Perth Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Saudi Arabia

Riyadh
King Faisal Specialist Hospital and Research Centre
Status: Active
Contact: Site Public Contact
Phone: 011-966-1-464-7272 ext 38005

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) of children >= 3 years of age with wingless-type MMTV integration site family (WNT)-driven average-risk medulloblastoma using reduced craniospinal radiotherapy (CSI) (18 Gray [Gy]) with a limited target volume boost to the tumor bed of 36 Gy for a total of 54 Gy and reduced chemotherapy approach (no vincristine [vincristine sulfate] during radiotherapy and reduced-dose maintenance chemotherapy) and to monitor the PFS for early evidence that the outcome is unacceptable.

SECONDARY OBJECTIVES:

I. To prospectively test the hypothesis that deoxyribonucleic acid (DNA) methylation profiling will accurately classify WNT-driven medulloblastoma.

II. To prospectively evaluate and longitudinally model the cognitive, social, emotional, behavioral, and quality of life (QoL) functioning of children who are treated with reduced CSI (18 Gy) with a limited target volume boost to the tumor bed (to a total of 54 Gy) and reduced chemotherapy (reduced cisplatin, vincristine, and lomustine [CCNU]).

EXPLORATORY OBJECTIVES:

I. To explore whether DNA methylation profiling of medulloblastoma samples will result in a predictive classification scheme for the Sonic Hedgehog (SHH), Group 3, and Group 4 medulloblastoma subgroups according to the Heidelberg classifier.

II. To describe the audiologic and endocrinologic toxicities, as well as peripheral neuropathy, in children treated with reduced CSI (18 Gy) with a limited target volume boost to the tumor bed (to a total of 54 Gy) and reduced cisplatin and vincristine chemotherapy.

OUTLINE:

RADIATION THERAPY: Beginning 4-5 weeks after surgery, patients undergo craniospinal radiation therapy 5 days a week for 6 weeks.

MAITENANCE THERAPY (WEEKS 1, 3, 5, and 7): Beginning 4-6 weeks after completion of radiation therapy patients receive lomustine orally (PO) on day 1, vincristine sulfate intravenously (IV) over 1 minute or via minibag on days 1, 8, and 15, and cisplatin IV over 6 hours on day 1. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY (WEEKS 2, 4, AND 6): Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 2, mesna IV over 15-30 minutes on days 1 and 2, and vincristine sulfate IV over 1 minute or via minibag on days 1 and 8. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually for 6 years.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Childrens Oncology Group

Principal Investigator
Nicholas Joseph Gottardo

Trial IDs

Primary ID ACNS1422
Secondary IDs NCI-2016-00150
Clinicaltrials.gov ID NCT02724579