Embryonal Tumor With Multilayered Rosettes
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).
| Condition(s) | Embryonal Tumor With Multilayered Rosettes, Embryonal Tumor With Multilayered Rosettes, Nos |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 | The eligibility criteria listed below are interpreted literally and cannot be waived. Inclusion Criteria: 1. 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. Particip |
| Sex | All |
| Lead sponsor | University of California, San Francisco |
| Locations | Birmingham, Alabama, United States; San Francisco, California, United States; Indianapolis, Indiana, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States; Hackensack, New Jersey, United States (+1 more sites) |
| Start date | 2025-03-06 |
| NCT ID | NCT06861244 |
| Official listing | https://clinicaltrials.gov/study/NCT06861244 |