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Intensive chemo combo shows promise for kids with aggressive brain cancer

NCT ID NCT02875314

Disease control Sponsor: Parth Patel Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving three rounds of very strong chemotherapy with stem cell rescue works better than one round for children under 10 with high-risk brain tumors. The goal is to improve survival without adding too many side effects. About 250 children will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2015

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 10 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients 10 years of age at the time of definitive confirmatory eligible histologic or cytologic diagnosis of eligible CNS tumor (brain or spinal cord) * Patients may not have received irradiation or chemotherapy (except corticosteroids) * Have histologically proven diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord * Medulloblastoma * Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap frozen) for proposed assays: all stages, age less than 6 years at diagnosis * Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less than 10 years at diagnosis * Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis, will only be eligible if they have evidence of neuraxis or extraneural dissemination. Patients 6 years of age and above with low-stage (standard-risk, M0) medulloblastoma will NOT be eligible for this study, irrespective of molecular subgroup and extend of local resection * CNS Embryonal Tumors: \- Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with multi-layered rosettes (ETMR, including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI1 intact) and CNS embryonal tumor, not otherwise specified. * Must commence Induction chemotherapy within 28 days of the most recent definitive surgical procedure and within 21 days of the most recent neuro-imaging studies (MRI of brain, performed with and without gadolinium contrast, and MRI of total spine, performed with gadolinium contrast) and lumbar CSF cytological examination * Patients must have adequate organ functions at the time of registration: * Liver: bilirubin less than 1.5 mg/dL (except for patients with Gilbert's Syndrome of indirect hyperbilirubinemia) and transaminases \[SGPT or ALT, and SGOT or AST\] less than 2.5 (two and a half) times the upper limits of institutional normal. * Renal: Creatinine clearance and/or glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m² within 21 days of protocol therapy. * Bone Marrow Function: 1. Peripheral absolute phagocyte count (APC) \> 1000/ µL. APC = numbers of banded neutrophils + segmented neutrophils + metamyelocytes + monocytes + eosinophils Please note, if institution reports differential as a percentage, then APC = \[percentage of banded neutrophils + segmented neutrophils+ metamyelocytes+monocytes+eosinophils\] x total white cell count. 2. Platelet Count \> 100,000/µL (transfusion independent) 3. Hemoglobin \> 8 gm/dL (may have received RBC transfusions). Exclusion Criteria: * Patients older than 10 years of age at time of diagnosis * Following diagnoses are not eligible for study enrollment: CNS atypical teratoid/rhabdoid tumor (AT/RT); all ependymomas including anaplastic ependymomas of the brain or spinal cord; all choroid plexus carcinomas; all high-grade glial and glio-neuronal tumors; all primary CNS germ cell tumors; all primary CNS sarcomas; all primary or metastatic CNS lymphomas and solid leukemic lesions (i.e., chloromas, granulocytic sarcomas). * Patients with unbiopsied diffuse intrinsic pontine tumors will NOT be eligible for this study.

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Conditions

The condition(s) this trial relates to.

atypical teratoid rhabdoid tumor central nervous system primitive neuroectodermal neoplasm cerebral neuroblastoma childhood central nervous system primitive neuroectodermal neoplasm embryonal tumor with multilayered rosettes ganglioneuroblastoma medulloblastoma medulloepithelioma pineoblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Central nervous system embryonal tumors Medulloblastoma

Contacts and locations

Locations

  • Akron Children's Hospital

    Akron, Ohio, 44308, United States

  • Alberta Children's Hospital

    Calgary, Canada

  • American Family Children's Hospital/University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • B.C. Children's Hospital

    Vancouver, British Columbia, V6H 3V4, Canada

  • Carolina's HealthCare System/Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Central Michigan University

    Detroit, Michigan, 48201, United States

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30342, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital Orange County

    Orange, California, 91868, United States

  • Children's Hospital of Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Children's Specialty Care of Nevada

    Las Vegas, Nevada, 89135, United States

  • Children's of Alabama

    Birmingham, Alabama, 35233, United States

  • Christchurch Children's Hospital

    Christchurch, New Zealand

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia Presbyterian Children's Hospital

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dayton Children's Hospital

    Dayton, Ohio, 45404, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Hamilton Health/McMasters Children's Hospital, Hamilton, Canada

    Hamilton, Canada

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503, United States

  • John's Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701, United States

  • John's Hopkins University School of Medicine

    Baltimore, Maryland, 21287, United States

  • Joseph Sanzari Children's Hospital/ Hackensack University

    Hackensack, New Jersey, 07601, United States

  • Loma Linda University Medical Center

    Loma Linda, California, 92350, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Masonic Children's Hospital/University of Minnesota

    Minneapolis, Minnesota, 55454, United States

  • Mattel Children's Hospital (UCLA)

    Los Angeles, California, 90095, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 58226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Care Health Services

    Long Beach, California, 90806, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Morristown Medical Center, Atlantic Health System

    Morristown, New Jersey, 07960, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Nemours Center for Cancer and Blood Disorders

    Wilmington, Delaware, 19803, United States

  • Nemours Center for Cancer and Blood Disorders

    Jacksonville, Florida, 19803, United States

  • New York Medical College

    Hawthorne, New York, 10532, United States

  • Nicklaus Children's Hospital

    Miami, Florida, 33155, United States

  • Northwell Health

    Hempstead, New York, 11549, United States

  • Orlando Health

    Orlando, Florida, 32806, United States

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17033, United States

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Rainbow Babies & Children's Hospital

    Cleveland, Ohio, 44106, United States

  • Riley Children's Hospital/University of Indiana

    Indianapolis, Indiana, 46202, United States

  • Shands Children's Hospital/ University of FL

    Gainesville, Florida, 32608, United States

  • Starship Children's Hospital

    Auckland, New Zealand

  • Stollery Children's Hospital

    Edmonton, Canada

  • The Hospital of Sick Children

    Toronto, Canada

  • UCSF Oakland Benioff

    Oakland, California, 94609, United States

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Louisville School of Medicine

    Louisville, Kentucky, 40202, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Upstate Golisano Children's Hospital/ SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23219, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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