HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors (NCT02875314)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's of Alabama — Birmingham, Alabama
Age range: Not specified to 10 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (62 Sites)
Showing the first 25 of 62 sites.
- Children's of Alabama — Birmingham, Alabama
- Phoenix Children's Hospital — Phoenix, Arizona
- Arkansas Children's Hospital — Little Rock, Arkansas
- Loma Linda University Medical Center — Loma Linda, California
- Memorial Care Health Services — Long Beach, California
- Children's Hospital Los Angeles — Los Angeles, California
- Mattel Children's Hospital (UCLA) — Los Angeles, California
- UCSF Oakland Benioff — Oakland, California
- Children's Hospital Orange County — Orange, California
- Children's Hospital Colorado — Aurora, Colorado
- Nemours Center for Cancer and Blood Disorders — Wilmington, Delaware
- Children's National Medical Center — Washington D.C., District of Columbia
- Shands Children's Hospital/ University of FL — Gainesville, Florida
- Nemours Center for Cancer and Blood Disorders — Jacksonville, Florida
- Nicklaus Children's Hospital — Miami, Florida
- Orlando Health — Orlando, Florida
- John's Hopkins All Children's Hospital — St. Petersburg, Florida
- Children's Healthcare of Atlanta — Atlanta, Georgia
- Riley Children's Hospital/University of Indiana — Indianapolis, Indiana
- University of Iowa Hospital and Clinics — Iowa City, Iowa
- University of Louisville School of Medicine — Louisville, Kentucky
- John's Hopkins University School of Medicine — Baltimore, Maryland
- Dana Farber Cancer Institute — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Central Michigan University — Detroit, Michigan
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Medulloblastoma
- Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma — Birmingham, Alabama
- A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma — Palo Alto, California
- A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma — Los Angeles, California
- Comparison of Neurocognitive Outcome in Two Standard Regimen for Treatment of Low-risk Medulloblastoma — Birmingham, Alabama
- Liothyronine in Combination With BIT Regimen for Medulloblastoma With or Without Minimal Residual Disease — San Francisco, California
Explore by condition: All Medulloblastoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.