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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
TORISEL® (temsirolimus) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
RECRUITINGTumor pharmacokinetics (PK) of temsirolimus
Total and unbound temsirolimus concentration in tumor tissue.
Time frame: Day 1 (Intraoperative)
Pharmacodynamic effects of temsirolimus
Quantification of the % of pS6 positive cells
Time frame: Day 1 (Intraoperative)
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