RecruitingEarly Phase 1NCT05773326

Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG

A Phase 0, Single-center, Open-label, Dose-escalating Trial Using Super-selective Intra-arterial Infusion of a Single Dose of Temsirolimus for the Treatment of Recurrent High-grade Glioma


Sponsor

Nader Sanai

Enrollment

12 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-center, open-label, dose-escalating Phase 0 trial that will enroll participants with a confirmed diagnosed recurrent high-grade glioma (grade 3 or 4 per WHO criteria) targeting the mTOR pathway. Eligible participants will be administered a single infusion of temsirolimus through super-selective intra-arterial infusion or intravenous infusion. Participants will receive the study drug administration on the same day as the planned surgical resection of the tumor.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a treatment called temsirolimus — a drug that blocks a cell growth pathway called mTOR — delivered directly into the brain's blood supply (via a specialized infusion technique) for people with high-grade glioma (aggressive brain tumors, grade 3 or 4) in the frontal lobe. The drug is given this way to get higher concentrations to the tumor while reducing body-wide side effects. **You may be eligible if...** - You have a confirmed high-grade glioma (grade 3 or 4) in the frontal lobe - Your tumor has been tested and shows signs of mTOR pathway activation (through specific genetic changes or protein markers) - You have completed standard treatment (the Stupp protocol: radiation + temozolomide) - You have measurable tumor remaining **You may NOT be eligible if...** - Your tumor is in a location other than the frontal lobe - Your tumor does not show mTOR pathway activity - You have not completed the standard Stupp treatment - You have certain vascular or blood clotting problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTemsirolimus

TORISEL® (temsirolimus) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.


Locations(1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

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NCT05773326


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