NCT04590664

Verteporfin for the Treatment of Recurrent High Grade EGFR-Mutated Glioblastoma

A Phase 1 / 2 Study of Visudyne (Liposomal Verteporfin) in Persons with Recurrent High Grade EGFR-Mutated Glioblastoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of Visudyne (liposomal verteporfin) and to see how well it works in treating patients with high grade EGFR-mutated glioblastoma that has come back (recurrent). Visudyne is FDA approved in combination with light to treat eye diseases. In this study we use Visudyne by itself like chemotherapy to kill tumor cells which may be sensitive to verteporfin.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of successively higher doses of verteporfin (Visudyne \[liposomal verteporfin\]) and determine the maximum tolerated dose (MTD) in study participants with recurrent EGFR positive (+) glioblastoma (GBM). (Phase I) II. To evaluate the anti-tumor activity of Visudyne by assessing progression-free survival (PFS) and overall survival (OS). (Phase II) III. To describe the response rate of EGFR+ GBM in study participants treated with Visudyne. (Phase II) SECONDARY OBJECTIVES: I. To evaluate the anti-tumor activity of Visudyne by assessing progression-free survival (PFS) and overall survival (OS). (Phase I) II. To describe the response rate of EGFR+ GBM in study participants treated with Visudyne. (Phase I) III. To describe pharmacokinetics of Visudyne administered on a weekly schedule. (Phase I) IV. To evaluate the safety and tolerability of successively higher doses of Visudyne in study participants with recurrent EGFR+ GBM. (Phase II) OUTLINE: This is a dose-escalation study. Patients receive verteporfin intravenously (IV) over 83 minutes weekly for 6 weeks in cycle 1, then weekly for 5 weeks in subsequent cycles. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 12 weeks.

Conditions

• Glioblastoma
• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Verteporfin	Given IV

Timeline

• Start date: 2021-01-15
• Primary completion: 2025-08-15
• Completion: 2025-08-15
• First posted: 2020-10-19
• Last updated: 2025-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study