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Brain cancer trial aims to customize therapy, reduce side effects

NCT ID NCT01878617

Disease control Sponsor: St. Jude Children's Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a personalized approach to treating medulloblastoma, a type of brain cancer. Instead of using a one-size-fits-all treatment, the study assigns radiation and chemotherapy doses based on the tumor's molecular subtype and the patient's risk level. The goal is to see if lower doses can be used for some patients to reduce side effects while maintaining survival, and if adding targeted drugs helps others. The trial enrolled 660 children and young adults across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiation therapy and chemotherapy (cyclophosphamide, cisplatin)
What this could lead to
If successful, this approach could tailor treatment for medulloblastoma, potentially improving survival while reducing side effects for some patients.
What could go wrong
This is a phase 2 trial, so results are not yet proven. The treatment involves significant side effects from radiation and chemotherapy, and not all subgroups may benefit.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

660 people

The number who actually took part.

Started

Jun 2013

Expected to finish

Oct 2031

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

3 to 39 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 * Medulloblastoma or medulloblastoma variants including posterior fossa PNET as documented by an institutional pathologist. * Participant's age meets one of the following: (1) Age greater than or equal to 3 years and less than 22 years of age at the time of diagnosis (may enroll on Strata W, S or N), OR (2) age is greater than or equal to 22 years and less than 40 years AND patient has SHH medulloblastoma (must enroll on Stratum S). * No previous radiotherapy, chemotherapy or other brain tumor directed therapy other than corticosteroid therapy and surgery. * Patients must begin treatment as outlined in the protocol within 36 days of definitive surgery (day of surgery is day 0; definitive surgery includes second surgeries to resect residual tumor). * Adequate performance status: children \< 10-Lansky Score ≥ 30; children ≥ 10-Karnofsky ≥ 30 (except for posterior fossa syndrome). * Females of child-bearing potential cannot be pregnant or breast-feeding. Female participants \> 10 years of age or post-menarche must have a negative serum or urine pregnancy test prior to enrollment. * Biological parent(s) of participant (child) enrolling on this protocol. These parents will be assigned to cohort P. The exclusion criteria below do not apply to this cohort. EXCLUSION CRITERIA * CNS embryonal tumor other than medulloblastoma or PNET in the posterior fossa, for example, patients with diagnosis of Atypical Teratoid / Rhabdoid Tumor (ATRT), supratentorial PNET, pineoblastoma, ependymoblastoma, ETANTR are excluded. * Research participants with other clinically significant medical disorders that could compromise their ability to tolerate protocol therapy or would interfere with the study procedures or results history. Participants in the Stratum S maintenance chemotherapy portion of the study must meet the criteria below prior to start of vismodegib therapy: * Participants must be Stratum S (SHH) * Participants must be skeletally mature defined as females with a bone age ≥ 15 years and males with a bone age ≥ 17 years. * Must be able to swallow pills * BSA must be \>0.67 and \<2.5 m2 * Male and female participants of reproductive potential must agree to effective contraception during and after study treatment. See Appendices I and II for further guidance for participants receiving vismodegib * ANC ≥ 1000/mm\^3 (after G-CSF discontinued) * Platelets ≥ 50,000/mm\^3 (without support) * Hgb ≥ 8 g/dL (with or without transfusion support) * Serum creatinine ≤ 1.5 mg/dL * Total bilirubin ≤ 1.5X the institutional ULN * SGPT (ALT) ≤ 2.5X the institutional ULN * SGOT (AST) ≤ 2.5X the institutional ULN * Alkaline Phosphatase ≤ 1.5X the institutional ULN * Serum albumin ≥ 2.5 g/dL Participants in the exercise intervention portion of the study must meet all criteria below: * Must be ≥ 5 years and \< 22 years at the time of enrollment * Must have no congenital heart disease * Must be capable of performing the exercise intervention at the time of baseline assessment as determined by the treating physician. Participants in the cognitive remediation intervention portion of the study must meet all criteria below: * Completed protocol-directed radiation therapy * ≥5 years at the time of remediation intervention consent or age is greater than or equal to 22 years and less than 40 years and patient has SHH medulloblastoma * English as primary language and training aide who speaks English available to participate in required sessions * No significant cognitive impairment operationalized as either an IQ \< 70 for children with St. Jude SJMB12 study baseline testing or based on clinician judgment baseline IQ missing * No major sensory or motor impairment that would preclude valid cognitive testing (e.g., unresolved posterior fossa syndrome, blindness, poorly controlled seizures/photosensitive epilepsy, psychosis) or a major psychological condition that would preclude completion of the intervention (e.g., significant oppositionality, autism spectrum disorder, severe anxiety or depressive symptoms)

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Conditions

The condition(s) this trial relates to.

brain cancer infratentorial cancer medulloblastoma Neuroectodermal Tumors, Primitive

As listed by the trial registrant

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

Medulloblastoma

Contacts and locations

Locations

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8, Canada

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806, United States

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • Children's Hospital and Clinics of Minnesota

    Minneapolis, Minnesota, 55102, United States

  • Children's Hospital at Westmead

    Westmead, New South Wales, 2145, Australia

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's National Medical Center

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

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104, United States

  • Duke Children's Hospital and Health Center

    Durham, North Carolina, 27710, United States

  • Lucille Packard Children's Hospital at Stanford University Medical Center

    Palo Alto, California, 94304, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Perth Children's Hospital

    Perth, Western Australia, 6008, Australia

  • Queensland Children's Hospital

    Brisbane, Queensland, 4029, Australia

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • Royal Children's Hospital, Melbourne

    Melbourne, Victoria, 3052, Australia

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • Starship Children's Hospital

    Auckland, 1142, New Zealand

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031, Australia

  • Texas Children's Cancer Center

    Houston, Texas, 77030-2399, United States

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • University of Florida

    Gainesville, Florida, 32611, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.