Actively Recruiting
Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma
Led by St. Jude Children's Research Hospital · Updated on 2026-02-12
130
Participants Needed
10
Research Sites
653 weeks
Total Duration
On this page
Sponsors
S
St. Jude Children's Research Hospital
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presumptive or suspected newly diagnosed medulloblastoma
- Age less than 60 months at enrollment
- Adequate tumor tissue available for central pathology and molecular testing
- Able to begin treatment within 36 days after definitive tumor surgery
- Parent or legal guardian able and willing to sign informed consent
- Disease staged by MRI of brain and spine and CSF cytology unless medically contraindicated
- No prior radiotherapy, chemotherapy, or brain tumor-directed therapy except corticosteroids and surgery
- Lansky performance score greater than 30 except for patients with posterior fossa syndrome
- Adequate organ function including blood counts, liver enzymes, and renal function as specified
- Molecular subgroup confirmed for treatment strata: SHH-2 for Stratum S-2, SHH-1, SHH-3, SHH-4, or SHH-NOS for Stratum S-1, and G3, G4, or NWNS/indeterminate for Stratum N
- Stratum S-2: Age less than 36 months or 36-60 months with non-metastatic disease
- Stratum S-1: Age less than 36 months regardless of metastatic status
- Stratum N: Age less than 36 months; all NWNS patients eligible regardless of metastasis
You will not qualify if you...
- Diagnosis of CNS tumors other than medulloblastoma such as ATRT, PNET, Pineoblastoma, Ependymoma, or ETMR
- Prior treatment for medulloblastoma including radiotherapy, chemotherapy, immunotherapy, or targeted agents
- Actively receiving any other investigational agents
- Serious medical disorders that could interfere with treatment or study procedures such as serious infections or significant cardiac, pulmonary, hepatic, psychiatric, or other organ dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Lucille Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
2
Orlando Health Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
3
St. Joseph's Children's Hospital
Tampa, Florida, United States, 33607
Actively Recruiting
4
C.S. MOTT Children's Hospital, University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
6
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
7
UT Southwestern Medical Center/Harold C Simmons Comprehensive Cancer Center
Dallas, Texas, United States, 75235
Actively Recruiting
8
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
9
Texas Children's Hospital
Houston, Texas, United States, 77477
Actively Recruiting
10
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
Research Team
T
Tabatha E. Doyle, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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