Who is eligible for clinical trial NCT07291102?

Participants must meet protocol criteria for Medulloblastoma. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07291102 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-12-17

Comparison of Neurocognitive Outcome in Two Standard Regimen for Treatment of Low-risk Medulloblastoma (NCT07291102)

🟡 Not Yet Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Nationwide Children's Hospital

🩺 Plain-English Summary (8th-Grade Level)

This is a trial to compare neurocognitive outcomes in the intent-to-treat population 2.5 years after diagnosis between patients with newly diagnosed, non-metastatic, SHH-activated, TP53-wt, non-MYC amplified MF randomized to the interventional arms A ("Head Start 4") or B (HIT-SKK).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (44 items).

Location: Children's of Alabama — Birmingham, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

for screening:
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)

Usually NOT eligible if any of the following apply:

Exclusion Criteria for overall study:
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 Inclusion Criteria for Bridging chemotherapy (carboplatin/etopiside) in interventional arms:
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Children's of Alabama — Birmingham, Alabama
Nationwide Children's Hospital — Columbus, Ohio

💰 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.

🏛️ View Official NIH Record ↗