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RECRUITING
NCT06861244
PHASE2

Embryonal Tumor With Multilayered Rosettes

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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).

Official title: PNOC031: Protocol for Embryonal Tumor With Multilayered Rosettes (ETMR)

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-03-06

Completion Date

2032-03-31

Last Updated

2026-04-08

Healthy Volunteers

No

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

Locations (7)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California, San Francisco

San Francisco, California, United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Washington University in St. Louis

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States