RecruitingPhase 2

Embryonal Tumor With Multilayered Rosettes

United States70 participantsStarted 2025-03-06

Plain-language summary

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).

Who can participate

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Median Progression-free survival at 6 months (PFS6) (Cohort 1)

Timeframe: Up to 6 months

Trial details

NCT IDNCT06861244

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-09-30

Contact for this trial

PNOC Operations Office

415-502-1600 PNOC031@ucsf.edu

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