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Embryonal Tumor With Multilayered Rosettes

NCT06861244 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-23

No results posted yet for this study

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).

Conditions

  • Embryonal Tumor With Multilayered Rosettes
  • Embryonal Tumor With Multilayered Rosettes, Nos

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

Sponsors & Collaborators

Principal Investigators

  • Sabine Mueller, MD, PhD, MAS · University of California, San Francisco

  • Derek Hanson, MD · Hackensack Meridian Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-06
Primary Completion
2030-09-30
Completion
2032-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06861244 on ClinicalTrials.gov