PNOC031: Protocol for Embryonal Tumor With Multilayered Rosettes (ETMR)
University of California, San Francisco
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).
Description
PRIMARY OBJECTIVES I. To determine the six-month progression-free survival (PFS6) of participants with newly diagnosed, gross-totally resected, non-metastatic ETMR, treated using a regimen of induction chemotherapy and early focal radiotherapy (Cohort 1) SECONDARY OBJECTIVES I. To determine the two-year progression-free survival (PFS) and overall survival (OS) of participants with newly diagnosed, gross-totally resected, non-metastatic ETMR (Cohort 1). II. To determine the two-year progression-free survival (PFS) and overall survival (OS) of participants with newly diagnosed, gross-totally r…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- RadiationRadiotherapy (RT)
Undergo RT
- DrugChemotherapy 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.
- ProcedureNon-Investigational Surgical Resection
Undergo surgery directly before study enrollment as part of planned care.
- DrugTemozolomide
Participants assigned to or whom receive optional RT will receive concurrent temozolomide
- ProcedureTumor Tissue Sample
Tumor tissue will be collected for correlative studies
- Procedure
Locations (7)
- University of Alabama at BirminghamBirmingham, Alabama
- University of California, San FranciscoSan Francisco, California
- Riley Hospital for Children at Indiana University HealthIndianapolis, Indiana
- Johns Hopkins UniversityBaltimore, Maryland
- Washington University in St. LouisSt Louis, Missouri
- Hackensack University Medical CenterHackensack, New Jersey