An interventional study of Personalized Treatment Recommendation in Rare CNS Tumor, FOXR2-activated and BCOR ITD Sarcoma, sponsored by Adriana Fonseca. Not yet recruiting at 1 site in United States. Open to participants aged Up to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Adriana Fonseca · Not applicable, Interventional, and Other
The current study will use a new treatment approach based on the molecular characteristics of each participant's tumor. The study will test the feasibility in of performing real-time drug screening on tissue taken during surgery in patients with relapsed ultra rare brain tumors (BCOR -altered, MN1-altered, CNS Sarcomas, other rare brain tumors) and of having a specialized tumor board assign a treatment plan based on the results of the drug screening and genomic sequencing. The aim of this trial is to allow every child and young adult with relapsed ultra rare brain tumors to receive the most effective and least toxic therapies currently available and will pave the way for improved understanding and treatment of these tumors in the future. Moreover, if successful, it could serve as a paradigm for personalized medicine programs for other types of cancer.
Following clinically indicated biopsy or resection, fresh tissue will be submitted for real-time high-throughput drug screening and tumor/paired-normal molecular profiling will be initiated. A specialized tumor board will issue a documented management recommendation within 28 days . Recommendations will integrate successful drug screening, all molecular/pathology data available at the time of review, prior therapy, and clinical context. Later molecular results may prompt an addendum. The treating physician retains responsibility for final treatment decisions.
1,960 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →This is the only study on the registry with Adriana Fonseca as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients must have a relapse or recurrence of one of the following rare brain tumors:
Participant must be a candidate for surgical resection or biopsy.
Prior therapy
Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Adequate neurologic function defined as:
Exclusion Criteria:
Participants will be provided a treatment recommendation by the tumor board within 28 days from tissue acquisition. Based on the results of the real-time, High-throuput drug screeningRNA sequencing (RNAseq), whole genome sequencing (WGS), and clinical details of each subject's tumor.
Other: Personalized Treatment Recommendation
Specialized Treatment Plan of up to four FDA approved drugs based on participant's screening results will be assigned by Rare Brain Tumor specialized tumor board. Recommendations will be provided and to primary physician.
Also known as: Individualized treatment plan, Specialized treatment plan
Number of participants for whom a treatment recommendations are completed within 28 calendar days from tissue collection.
Time from tissue collection to generation of tumor board recommendations will be used to determine the feasibility of using the results of real-time high-throughput screening, WGS and RNAseq of participant-derived specimens to guide treatment recommendations by a specialized tumor board, in a clinically-actionable timeframe, for children and young adults with recurrent ultra-rare brain tumors. Participants are expected to receive treatment plan within 28 calendar days.
Time frame: Up to 28 calendar days
Proportion of participants with Adverse events
Proportion of participants with grade 3 or higher toxicities as per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. Serious adverse events (SAEs), unexpected adverse reactions, and adverse events of special interest. Adverse events will be summarized by maximum grade and relationship to the drugs recommended by the tumor board.
Time frame: Up to 1 year
The preliminary clinical activity of tumor board-recommended treatment
Best overall radiographic response (CR , PR, SD, PD) as per RAPNO criteria in patients receiving tumor board-recommended treatment.
Time frame: Up to 2 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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