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HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors
Sponsor: Parth Patel
Summary
This is a prospective randomized clinical trial, to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a superior outcome compared to the single cycle Consolidation, given the substantially higher dose intensity of the tandem regimen, without significant addition of either short-term or long-term morbidities.
Official title: HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue
Key Details
Gender
All
Age Range
Any - 10 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2015-09
Completion Date
2030-12
Last Updated
2026-02-12
Healthy Volunteers
No
Interventions
Induction
vincristine, cisplatin, cyclophosphamide, etoposide, high-dose methotrexate
Single Cycle Intensive Chemotherapy
Carboplatin, thiotepa, etoposide
Tandem 3 Cycle Intensive Chemotherapy
Carboplatin, thiotepa
Locations (62)
Children's of Alabama
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Memorial Care Health Services
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Mattel Children's Hospital (UCLA)
Los Angeles, California, United States
UCSF Oakland Benioff
Oakland, California, United States
Children's Hospital Orange County
Orange, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Nemours Center for Cancer and Blood Disorders
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Shands Children's Hospital/ University of FL
Gainesville, Florida, United States
Nemours Center for Cancer and Blood Disorders
Jacksonville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Orlando Health
Orlando, Florida, United States
John's Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Riley Children's Hospital/University of Indiana
Indianapolis, Indiana, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Louisville School of Medicine
Louisville, Kentucky, United States
John's Hopkins University School of Medicine
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Central Michigan University
Detroit, Michigan, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Children's Hospital of Minnesota
Minneapolis, Minnesota, United States
Masonic Children's Hospital/University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Children's Specialty Care of Nevada
Las Vegas, Nevada, United States
Joseph Sanzari Children's Hospital/ Hackensack University
Hackensack, New Jersey, United States
Morristown Medical Center, Atlantic Health System
Morristown, New Jersey, United States
New York Medical College
Hawthorne, New York, United States
Northwell Health
Hempstead, New York, United States
NYU Langone Medical Center
New York, New York, United States
Columbia Presbyterian Children's Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Upstate Golisano Children's Hospital/ SUNY Upstate Medical University
Syracuse, New York, United States
Carolina's HealthCare System/Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
American Family Children's Hospital/University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
B.C. Children's Hospital
Vancouver, British Columbia, Canada
Alberta Children's Hospital
Calgary, Canada
Stollery Children's Hospital
Edmonton, Canada
Hamilton Health/McMasters Children's Hospital, Hamilton, Canada
Hamilton, Canada
The Hospital of Sick Children
Toronto, Canada
Starship Children's Hospital
Auckland, New Zealand
Christchurch Children's Hospital
Christchurch, New Zealand