Actively Recruiting
Embryonal Tumor With Multilayered Rosettes
Led by University of California, San Francisco · Updated on 2026-04-23
70
Participants Needed
7
Research Sites
368 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
P
Pediatric Neuro-Oncology Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, comprehensive, iterative investigation of evaluating the use of induction chemotherapy, high-dose chemotherapy, and focal radiation therapy in children with newly diagnosed Embryonal Tumor With Multilayered Rosettes (ETMR).
CONDITIONS
Official Title
Embryonal Tumor With Multilayered Rosettes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Molecularly or histologically confirmed embryonal tumor with multilayered rosettes
- Availability of at least 10-20 unstained tumor slides or 1 tumor block with 40% or more tumor content
- No prior tumor-directed therapy except surgery for Cohort 1 participants
- Prior tumor-directed therapy allowed for Cohorts 2 and 3 with study chair approval
- No prior radiation therapy for tumor treatment
- Participants of any age
- Willingness to begin induction chemotherapy within 28 days of surgery or discussion with study chairs if later
- Cohort 1: Gross total tumor resection, no metastasis, eligible for early radiotherapy based on age
- Cohort 2: Gross total tumor resection, no metastasis, eligible for high-dose chemotherapy based on age
- Cohorts 3A and 3B: Metastatic or residual disease, receiving early radiotherapy or high-dose chemotherapy respectively
- Radiotherapy age criteria: over 12 months for infratentorial tumor or over 15 months for supratentorial tumor
- Karnofsky score ≥ 50 for those over 16 years; Lansky score ≥ 50 for those 16 or younger
- Adequate blood counts: neutrophils and platelets above specified levels without recent transfusions
- Adequate kidney function: serum creatinine less than 1.5 times normal for age and gender
- Adequate liver function within specified laboratory limits
- Well-controlled seizure disorder allowed; anticonvulsant use reviewed for drug interactions
- Agreement to use contraception during and 4 months after study for men and women of childbearing potential
- Enrollment on PNOC COMP protocol if available
- Ability to understand and sign informed consent and assent as appropriate
You will not qualify if you...
- For Cohort 1: any prior tumor-directed therapy other than surgery
- Use of other investigational tumor-directed treatments
- History of allergic reactions to similar drugs used in this study
- Uncontrolled illnesses that could interfere with study participation
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Johns Hopkins University
Baltimore, Maryland, United States, 21218
Actively Recruiting
5
Washington University in St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
6
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
7
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
P
PNOC Operations Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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