Embryonal Tumor With Multilayered Rosettes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, San Francisco
About this trial
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).
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Radiotherapy (RT)
- Chemotherapy Drug, Cancer - Physician's Choice
- Non-Investigational Surgical Resection
- Temozolomide
- Tumor Tissue Sample
- Blood Sample
- Cerebrospinal Fluid (CSF) Sample
Treatment groups
70 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of California, San Francisco
Lead sponsor
Pediatric Neuro-Oncology Consortium
Collaborator
Solving Kids' Cancer
Collaborator
Source ClinicalTrials.gov