NCT06861244 · University of California, San Francisco
Embryonal Tumor With Multilayered Rosettes
(PNOC031)
What this study is about
This is an where both patients and doctors know the treatment given, 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).
View original scientific description
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).
Interventions
RADIATION
Radiotherapy (RT)
Undergo RT
DRUG
Chemotherapy Drug, Cancer - Physician's Choice
One or more of the following may be assigned by the physician (physician's choice) per standard of care guidelines upon study enrollment following surgery: Cytarabine, Carboplatin, Cisplatin, Vincristine Sulfate injection (Vincristine PFS), Topotecan Hydrochloride, Dactinomycin, Thiotepa, Filgrastim, Cyclophosphamide, or Doxorubicin Hydrochloride. Not all participants will receive all possible drug regimens.
PROCEDURE
Non-Investigational Surgical Resection
Undergo surgery directly before study enrollment as part of planned care.
DRUG
Temozolomide
Participants assigned to or whom receive optional RT will receive concurrent temozolomide
PROCEDURE
Tumor Tissue Sample
Tumor tissue will be collected for correlative studies
PROCEDURE
Blood Sample
Blood samples will be collected for correlative studies
PROCEDURE
Cerebrospinal Fluid (CSF) Sample
CSF samples will be collected for correlative studies
Primary outcome measures
Median Progression-free survival at 6 months (PFS6) (Cohort 1)
Time frame: Up to 6 months
The median PFS6 is defined as the median number of months for participants in Cohort 1 who have remained progression-free from the date of initial surgical resection until 6 months.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must have either a molecularly or histologically confirmed embryonal tumor with multilayered rosettes. 2. For enrollment, a confirmation of a minimum of 10-20 unstained formalin-fixed paraffin-embedded (FFPE) slides or 1 block (15-20 mg) with tumor content of 40% or greater is required. Anything less must be discussed and approved by the study chairs prior to enrollment. 3. Prior Therapy: 1. Cohort 1 participants must not have received any prior tumor-directed therapy other than surgical resection. 2. Cohort 2 and 3 participants may receive tumor-directed therapy prior to enrollment. These participants must be discussed with study chairs prior to enrollment. 4. Participants must not have received prior radiation for treatment of tumor. 5. Participants of any age are eligible. 6. Participants should begin induction chemotherapy within 28 days of the most rec
Where
- Birmingham, Alabama
- San Francisco, California
- Indianapolis, Indiana
- Baltimore, Maryland
- St Louis, Missouri
- Hackensack, New Jersey
- Memphis, Tennessee
- Salt Lake City, Utah
Collaborators
Pediatric Neuro-Oncology Consortium, Solving Kids' Cancer
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations