Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG
NCT05773326 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2026-05-14
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.
Conditions
- High Grade Glioma
- Glioma
- Glioma, Malignant
- Glioblastoma
Interventions
- DRUG
-
Temsirolimus
TORISEL® (temsirolimus) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.
Sponsors & Collaborators
-
Barrow Neurological Institute
collaborator OTHER -
Ivy Brain Tumor Center
collaborator OTHER -
Nader Sanai
lead OTHER
Principal Investigators
-
Nader Sanai, MD · Chief Scientific Officer/Director
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-15
- Primary Completion
- 2025-02-28
- Completion
- 2025-10-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
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