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RECRUITING Phase 2

Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma

NCT05535166 · View on ClinicalTrials.gov ↗

Study Summary

This is a multi-center, multinational phase 2 trial that aims to explore the use of molecular and clinical risk-directed therapy in treatment of children 0-4.99 years of age with newly diagnosed medulloblastoma.

Conditions Studied

Interventions

  • DRUG Cisplatin
  • DRUG Vincristine
  • PROCEDURE Surgical resection
  • DRUG Methotrexate
  • PROCEDURE Ommaya/VPS

Study Locations (10)

Texas

  • UT Southwestern Medical Center/Harold C Simmons Comprehensive Cancer Center — Dallas
  • Cook Children's Medical Center — Fort Worth
  • Texas Children's Hospital — Houston

Florida

  • Orlando Health Arnold Palmer Hospital for Children — Orlando
  • St. Joseph's Children's Hospital — Tampa

California

  • Lucille Packard Children's Hospital Stanford — Palo Alto

Michigan

  • C.S. MOTT Children's Hospital, University of Michigan — Ann Arbor

Minnesota

  • Children's Hospital and Clinics of Minnesota — Minneapolis

Tennessee

  • St. Jude Children's Research Hospital — Memphis

Utah

  • Primary Children's Hospital — Salt Lake City

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2022-12-20
Est. Completion 2035-07
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05535166

The ClinicalTrials.gov registry entry for NCT05535166 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 441 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Medulloblastoma appearing as the primary indexed condition, and to 5 interventions — of which Cisplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05535166 reports 10 study locations spanning 7 distinct geographic areas — top geographies include Texas, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05535166 about?

NCT05535166 is a clinical study titled "Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma". This is a multi-center, multinational phase 2 trial that aims to explore the use of molecular and clinical risk-directed therapy in treatment of children 0-4.99 years of age with newly diagnosed medulloblastoma.

What is the current status of trial NCT05535166?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2022-12-20. Estimated completion is 2035-07.

What conditions does trial NCT05535166 study?

This clinical trial studies the following conditions: Medulloblastoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05535166?

The interventions under investigation include: Cisplatin (DRUG), Vincristine (DRUG), Surgical resection (PROCEDURE), Methotrexate (DRUG), Ommaya/VPS (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05535166?

This trial is sponsored by St. Jude Children's Research Hospital, which has 441 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05535166 being conducted?

This trial has 10 study locations across California, Florida, Michigan, Minnesota, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial