← Back to Search

Photosensitizer

Verteporfin (Visudyne) for Glioblastoma

Phase 1 & 2

Recruiting

Led By William L Read, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Visudyne is a vesicant. Participants will likely have poor veins, and will require repeated intravenous treatments. Participants must be willing to have placed a central venous access, such as a portacath

Persons with recurrent or progressive grade 4 glioma (glioblastoma) are eligible for this study. Participants should have received standard first line therapy including radiation and temozolomide

Must not have

Persons with hereditary porphyria are ineligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study enrollment to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of Visudyne in treating patients with recurrent glioblastoma.

Who is the study for?

This trial is for adults with recurrent grade 4 glioblastoma that has EGFR mutations, who've had standard treatments including radiation and temozolomide. They may be on bevacizumab but not exclusively for anti-edema effects. Participants must have MRI evidence of tumor progression, agree to central venous access placement, and use effective contraception. ECOG performance status should be between 0-3.

What is being tested?

The study tests the safety and optimal dosage of Visudyne (liposomal verteporfin), typically used for eye diseases, as a solo treatment like chemotherapy targeting sensitive tumor cells in high-grade EGFR-mutated glioblastoma patients.

What are the potential side effects?

Visudyne can cause local tissue damage if it leaks from the vein (vesicant). Other potential side effects are unknown due to its new application; however, typical chemotherapy-related side effects could include nausea, fatigue, hair loss or increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am willing to have a central venous access device installed for my treatment.

Select...

I have a grade 4 glioma and have undergone standard treatment with radiation and temozolomide.

Select...

My tumor has a mutation or high levels of EGFR.

Select...

My health issues, except for any nerve-related ones, are mild.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have hereditary porphyria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study enrollment to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study enrollment to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study enrollment to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (Phase I)

Overall survival (Phase II)

Progression free survival (PFS) (Phase II)

+1 more

Secondary study objectives

Incidence of adverse events (Phase II)

Overall survival (Phase I)

PFS (Phase I)

+2 more

Side effects data

From 2010 Phase 4 trial • 31 Patients • NCT00473642

10%

cardiopulmonary arrest

10%

ACUTE MYOCARDIAL INFARCTION

100%

80%

60%

40%

20%

Study treatment Arm

Ranibizumab

Standard Fluence PDT

50% Fluence PDT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (verteporfin)Experimental Treatment1 Intervention

Patients receive verteporfin 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Verteporfin

2007

Completed Phase 4

~150

0 / 5Eligibility criteria met