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NCT05535166 · ClinicalTrials.gov registry record · Phase 2
Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma
A Phase 2 study of Medulloblastoma, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 10
- Study locations
NCT05535166: Recruiting Phase 2 study of Medulloblastoma, sponsored by St. Jude Children's Research Hospital.
NCT05535166 is a Phase 2 study of Medulloblastoma that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 130 participants, roughly in line with the 136-participant average among 29 other Medulloblastoma trials with a reported enrollment target. The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05535166, a Phase 2 study of Medulloblastoma, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
Progression free survival (PFS) will be measured from treatment initiation to the earliest of disease progression or death from any cause in stratum S-2 eligible M0 patients who receive at least 1 dose of the chemotherapy regimen. Patients who have not experienced one of these events will be censored at their last date of contact. The Kaplan-Meier estimate of PFS at two years will be computed. PFS will be compared to St. Jude historical cohorts using hazard ratios with 95% confidence intervals.
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
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2022-12-20 |
| Est. Completion | 2035-07 |
| Phase | Phase 2 |
What NCT05535166 shows while recruiting
NCT05535166 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 136-participant average among 29 other Medulloblastoma trials with a reported enrollment target.
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.
NCT05535166 lists 10 locations in 7 states (Texas, Florida, California).
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.
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).
Who is sponsoring clinical trial NCT05535166?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Medulloblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05535166's enrollment target sits among peer trials
130 9th of 29 higher than 20 of 29 other Medulloblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Medulloblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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