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Comparing Treatments for Low-Risk Medulloblastoma in Young Children

This study is comparing two standard chemotherapy treatments for young children (under 5 years old) with a specific type of brain tumor called low-risk medulloblastoma. The two treatments are called "Head Start 4" (Arm A) and "HIT-SKK" (Arm B). Researchers want to see how these treatments affect a child's brain function and learning abilities (neurocognitive outcomes) over time. To join, children must have a specific type of medulloblastoma (SHH-activated, TP53-wt, non-MYC amplified) and their families must be able to participate in follow-up appointments. The main goal is to measure neurocognitive outcomes using a test called WPPSIIV about 105 months (around 8.75 years) after diagnosis.

Study design
This interventional study plans to enroll 96 participants. It compares two different treatment approaches for medulloblastoma.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Neurocognitive outcomes will be measured at 105 months (about 8.75 years) after diagnosis.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07291102

Comparison of Neurocognitive Outcome in Two Standard Regimen for Treatment of Low-risk Medulloblastoma

Not Yet Recruiting
PHASE3Up to 5InterventionalTreatment
Nationwide Children's Hospital
~96 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:Bridging ChemotherapyInduction Cycles A1-A3Induction Cycles A4-5Consolidation Cycle A6HIT-SKK Chemotherapy Cycles B1-3Modified HIT-SKK Cycle B4-5

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neurocognitive Outcomes using WPPSIIV
Measured over 105 months

Conditions

Medulloblastoma

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NCT07291102

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's of Alabama

    Birmingham, Alabamastudy coordinator listed

  • Nationwide Children's Hospital

    Columbus, Ohiostudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Maryam Fouladi, MD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital
  • Girish Dhall, MD · STUDY_CHAIR · Children's Hospital of Alabama

Who to contact

Kelsey Troyer, PhD
[email protected]
16147228566
Email the study team

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Eligibility criteria

Inclusion

Age at diagnosis \< 5 years
Patients with institutional suspicion or diagnosis of SHH-activated MB
Patient and family in social circumstances that will allow neuropsychological follow-up
Ability of parents/legal representatives to understand the patient information and to personally sign and date the informed consent to participate in screening procedures
Patient and the parents/legal representative are able and willing to participate in the entire study (if patient is eligible)
Patients with SHH-activated MB, TP53-wt demonstrated by IHC for Gab1 or p75-NGFR, Yap1, beta-catenin, and TP53 (lack of strong and widespread nuclear p53 positivity) on central review according to WHO classification 2021.
No clinical evidence of extra-CNS metastases
Negative CSF cytology
No prior therapy for MB other than surgery
No other medical contraindications to chemotherapy:
No uncontrolled invasive fungal infection or other severe systemic infection requiring system/parental therapy
No other severe organ dysfunctions, which cannot be clinically controlled
No concomitant use with yellow fever vaccine and with live virus and bacterial vaccines
No demyelinating form of Charcot-Marie-Tooth syndrome
Assessment of hearing function completed
No evidence of cancer predisposition syndromes other than Gorlin syndrome or ELP1, GPR161 germline alterations.
Provided written informed consent by parent(s)/parent representative(s) by bridging chemotherapy
Patient should be enrolled within 28 days after diagnosis. Bridging chemotherapy can start as early as criteria for enrollment are met, and must start no later than 33 days after diagnosis
Other histology than SHH MB
Patient has received bridging chemotherapy as described in this protocol
Patients with centrally reviewed SHH-activated MB, TP53-wt, according to WHO classification 2021
Absence of metastatic disease on central radiology review
Exclusion of TP53-mutation by DNA sequencing of the TP53-gene from tumor tissue by central review. Results from local institution will be accepted if raw data of this analysis is forwarded to the national central review institution
Confirmation of SHH activation by DNA methylation-based classification on central review. Results from local institution will be accepted if raw data of this analysis is forwarded to the national central review institution
No amplification of MYC (amplification of MYCN allowed). Array-based technologies (850k array, molecular inversion probe assay (MIP)), array-based comparative genomic hybridization (array-CGH) or next generation sequencing (NGS) DNA sequencing coverage MYC locus will be used. If these alternative assays give any indication of possible amplification, FISH will be performed on central review.
No other medical contraindications to chemotherapy:
No uncontrolled invasive fungal infection or other severe systemic infection requiring system/parental therapy
No other severe organ dysfunctions, which cannot be clinically controlled
No concomitant use with yellow fever vaccine and with live virus and bacterial vaccines
No demyelinating form of Charcot-Marie-Tooth syndrome
Retrospective assessment of pre-operative health-related QoL (HR-QoL) measured by Pediatric Quality of Life Inventory
Provided written informed consent by parent(s)/parent representative(s) for randomization

Exclusion

Patients previously treated for any other brain tumor or any type of malignant disease
Patients, in whom compliance with toxicity management guidelines and study procedures cannot be assured
History of hypersensitivity to an investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of an investigational medicinal product.
Patients/parents who do not wish to abstain from treatment with live vaccines during study participation
Patients with a language barrier too extensive to complete neuropsychological tests based on the investigator's judgement
Patients with severe premorbid developmental delay (based on the investigator's judgement), which will not allow WPPSI-IV assessment after 2.5 years
Patients cannot undergo MRI
Patients are excluded from the interventional study if any of the following criteria are met:

What this trial measures

  • Neurocognitive Outcomes using WPPSIIV105 months

    To compare neurocognitive outcomes 2.5 years after diagnosis between patients randomized to the interventional arms A ("Head Start" 4) and B (HIT-SKK). Full-Scale Intelligence Quotient (IQ) as measured by the Wechsler Preschool and Primary Scale of Intelligence (WPPSIIV) administered to those between the ages of 2 years and 6 months to 7 years and 7 months old at 2.5 years after diagnosis (+/- 6 months).