Embryonal Tumor With Multilayered Rosettes

Recruiting now · Phase 2

Conditions studied: Embryonal Tumor With Multilayered Rosettes, Embryonal Tumor With Multilayered Rosettes, Nos

In brief

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).

Key facts

Study ID

NCT06861244

Run by

University of California, San Francisco

People needed

70

Starts

2025-03-06

Expected to finish

2032-03-31

Last updated by the study team

2026-06-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have either a molecularly or histologically confirmed embryonal tumor with multilayered rosettes.
• 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.
• Prior Therapy:
• Cohort 1 participants must not have received any prior tumor-directed therapy other than surgical resection.
• Cohort 2 and 3 participants may receive tumor-directed therapy prior to enrollment. These participants must be discussed with study chairs prior to enrollment.
• Participants must not have received prior radiation for treatment of tumor.
• Participants of any age are eligible.
• Participants should begin induction chemotherapy within 28 days of the most recent definitive surgical procedure. Participants beginning therapy beyond 28 days from surgery, will need to discuss with study chairs.
• Cohort specific eligibility
• Cohort 1: Gross-total resection, Eligible for early radiotherapy (please see age criteria below), and no evidence of metastatic disease.
• Cohort 2: Gross-total resection, high dose chemotherapy (please see age criteria below), and no evidence of metastatic disease.
• Cohort 3A: Metastatic or residual disease, and early radiotherapy.
• Cohort 3B: Metastatic or residual disease, and high dose chemotherapy.
• Radiotherapy Age Criteria (at the time of planned radiation): >12 months of age for participants with infratentorial tumor OR >15 months of age for participants with supratentorial tumor. For participants being treated on radiotherapy-containing arms, the legal parent/guardian or patient and the physician must be willing to allow the use of radiotherapy for treatment.
• Performance Score: Karnofsky >= 50 for participants > 16 years of age and Lansky >= 50 for participants <=16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• Organ Function Requirements:
• Peripheral absolute neutrophil count (ANC) > 75,000/mm3
• Platelet count > 75,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 72 hours prior to enrollment).
• Adequate Renal Function defined as:
• a. Serum creatinine < 1.5 x upper limit normal (ULN) based on age and gender.
• Adequate Liver Function defined as:
• Total bilirubin < 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin < 3 x ULN or direct bilirubin < 1.5 x ULN,
• alanine aminotransferase (ALT) < 3 x ULN,
• aspartate aminotransferase (AST) < 3 x ULN,
• Adequate Neurologic Function defined as:

You may not qualify if…

• Cohort 1 only: Participants who have received any prior tumor-directed therapy other than surgical intervention
• Participants who are receiving any other tumor directed investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study.
• Uncontrolled intercurrent illness.
• Women of childbearing potential must not be pregnant or breast-feeding.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Washington University in St. Louis — St Louis, Missouri, United States (enrolling)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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