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 a confirmed molecular diagnosis of classical histologic type (non large cell/anaplastic [LC/A]) WNT medulloblastoma from rapid central pathology screening review on APEC14B1 (immunohistochemistry [IHC]/molecular screening [positive nuclear beta (B)-catenin by IHC and positive for catenin beta 1 [CTNNB1] mutation) and confirmation of =< 1.5 cm^2 maximal cross-sectional area of residual tumor from rapid central imaging review
  • Patient must have negative lumbar cerebrospinal fluid (CSF) cytology; CSF cytology for staging should be performed preferably 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 * Note: patients with positive CSF cytology obtained prior to 14 days after surgery may have cytology repeated to determine eligibility and final CSF status
  • Patients must have eligibility confirmed by rapid central imaging review on APEC14B1; standard whole brain magnetic resonance imaging (MRI) with and without contrast (gadolinium) and spine MRI with contrast (gadolinium) must be performed at the following time points: * Pre-operative to include an MRI of the brain with and without contrast (including post-contrast three-dimensional [3D] T1-weighted image [T1WI] and post-contrast fluid-attenuated inversion recovery [FLAIR]) * Pre-operative spinal MRI with gadolinium; post-operative staging spinal MRI may be obtained if pre-operative imaging is not possible or is suboptimal; pre-operative spine imaging is strongly preferred, due to the potential of post-operative sequelae, which could affect metastasis detection * Post-operative brain MRI within 72 hours of surgery
  • Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1422 * Patients must be enrolled within 36 days of definitive diagnostic surgery (day 0) ** Note: patients must begin treatment within 36 days of definitive surgery
  • Patients must have no previous radiotherapy or chemotherapy other than corticosteroids
  • 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]) =< 110 U/L (for the purpose of this study, the upper limit of normal [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
  • 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 tumor-directed therapy other than surgical intervention and corticosteroids
  • Female patients who are pregnant are ineligible
  • 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

Locations & Contacts

Alabama

Birmingham
Children's Hospital of Alabama
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

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 Email: helpdesk@childrensoncologygroup.org
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 Email: helpdesk@childrensoncologygroup.org

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
Los Angeles
Children's Hospital Los Angeles
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Madera
Children's Hospital Central California
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Oakland
Children's Hospital and Research Center at Oakland
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.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 Email: helpdesk@childrensoncologygroup.org
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Sacramento
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 Email: helpdesk@childrensoncologygroup.org
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Connecticut

Hartford
Connecticut Children's Medical Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Delaware

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

Florida

Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Miami
Nicklaus Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Orlando
Florida Hospital Orlando
Status: Active
Contact: Site Public Contact
Phone: 407-303-2090 Email: FH.Cancer.Research@flhosp.org
Nemours Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
West Palm Beach
Saint Mary's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Georgia

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 Email: helpdesk@childrensoncologygroup.org

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
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
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 Email: helpdesk@childrensoncologygroup.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: helpdesk@childrensoncologygroup.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 Email: helpdesk@childrensoncologygroup.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 Email: helpdesk@childrensoncologygroup.org
Detroit
Saint John Hospital and Medical Center
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 Email: helpdesk@childrensoncologygroup.org
Spectrum Health at Butterworth Campus
Status: Active
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: Active
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: 248-551-0360

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
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
The Childrens Mercy Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Saint Louis
Cardinal Glennon Children's Medical Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-6770
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 Email: helpdesk@childrensoncologygroup.org
University of Nebraska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 402-559-6941 Email: unmcrsa@unmc.edu

Nevada

Las Vegas
Children's Specialty Center of Nevada II
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Summerlin Hospital Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013 Email: research@sncrf.org
Sunrise Hospital and 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 Email: helpdesk@childrensoncologygroup.org
Newark
Newark Beth Israel Medical Center
Status: Active
Contact: Site Public Contact
Phone: 973-926-7230

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 Email: helpdesk@childrensoncologygroup.org
New York
Columbia University / Herbert Irving Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-305-6361 Email: nr2616@cumc.columbia.edu
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: 704-355-2884
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: 252-744-2391
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: 800-437-4010

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.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 Email: helpdesk@childrensoncologygroup.org
Dayton
Dayton Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
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 Email: helpdesk@childrensoncologygroup.org

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 Email: helpdesk@childrensoncologygroup.org
Philadelphia
Children's Hospital of Philadelphia
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Childrens Oncology Group
Status: In review
Contact: Nicholas Joseph Gottardo Email: nick.gottardo@health.wa.gov.au
Saint Christopher's Hospital for Children
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

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

Columbia
Palmetto Health Richland
Status: Active
Contact: Site Public Contact
Phone: 803-434-3680
Greenville
BI-LO Charities Children's Cancer Center
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

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 Email: helpdesk@childrensoncologygroup.org
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 Email: helpdesk@childrensoncologygroup.org
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 Email: helpdesk@childrensoncologygroup.org
Corpus Christi
Driscoll Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.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 Email: helpdesk@childrensoncologygroup.org
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 Email: helpdesk@childrensoncologygroup.org
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Site Public Contact
Phone: 210-450-3800 Email: phoresearchoffice@uthscsa.edu

Utah

Salt Lake City
Primary Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Vermont

Burlington
University of Vermont College of Medicine
Status: Active
Contact: Site Public Contact
Phone: 802-656-8990

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
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 Email: helpdesk@childrensoncologygroup.org
Roanoke
Carilion Clinic Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

Washington

Seattle
Seattle Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

West Virginia

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

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Marshfield
Marshfield Clinic
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

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 Email: helpdesk@childrensoncologygroup.org
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 Email: helpdesk@childrensoncologygroup.org
Ottawa
Children's Hospital of Eastern Ontario
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org
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 Email: helpdesk@childrensoncologygroup.org

Australia

Perth
Perth Children's Hospital
Status: Active
Contact: Site Public Contact Email: helpdesk@childrensoncologygroup.org

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)/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 result in “real-time” classification of WNT-driven medulloblastoma.

II. To use the ALTE07C1 protocol to prospectively evaluate and longitudinally model the cognitive, social, emotional and behavioral 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]).

TERTIARY OBJECTIVES:

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

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