NCT05773326

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Nader Sanai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Temsirolimus	TORISEL® (temsirolimus) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.

Timeline

• Start date: 2023-05-15
• Primary completion: 2026-05-01
• Completion: 2028-05-01
• First posted: 2023-03-17
• Last updated: 2025-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study