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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study enrollment to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (Phase I)
Overall survival (Phase II)
Progression free survival (PFS) (Phase II)
+1 moreSecondary outcome measures
Incidence of adverse events (Phase II)
Overall survival (Phase I)
PFS (Phase I)
+2 moreSide effects data
From 2010 Phase 4 trial • 31 Patients • NCT0047364210%
cardiopulmonary arrest
10%
ACUTE MYOCARDIAL INFARCTION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ranibizumab
Standard Fluence PDT
50% Fluence PDT
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
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,642 Previous Clinical Trials
2,563,878 Total Patients Enrolled
11 Trials studying Glioblastoma
324 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,692 Previous Clinical Trials
40,929,831 Total Patients Enrolled
323 Trials studying Glioblastoma
23,136 Patients Enrolled for Glioblastoma
William L Read, MDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have swelling that improved with bevacizumab, but my tumor still grew.I have stopped any cancer treatments, including chemotherapy, at least 7 days ago.I am currently using an Optune device and want to keep using it.My MRI shows my condition is getting worse, not just changes from radiation.I am willing to have a central venous access device installed for my treatment.I have completed brain radiation at least 90 days before starting this study.I am currently on bevacizumab for my condition but it's not working, yet I can continue it in the study.I am expected to complete at least 6 weeks of treatment without significant health decline.I can care for myself but may not be able to do heavy physical work.I agree to use birth control during and 8 weeks after the study.I am not pregnant and have taken a test to confirm this before starting therapy.It has been over 3 weeks since my last major surgery.I have severe nerve-related symptoms due to brain conditions.I don't have severe health issues, except for brain tumor-related problems.I have a grade 4 glioma and have undergone standard treatment with radiation and temozolomide.I do not have hereditary porphyria.My tumor has a mutation or high levels of EGFR.My health issues, except for any nerve-related ones, are mild.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (verteporfin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people will be given this medication as part of the trial?
"That is correct, the trial information hosted on clinicaltrials.gov shows that this study is currently recruiting patients. This particular trial was first posted on 1/15/2021 and was last updated on 2/17/2022. They are looking for a total of 24 patients at 1 site."
Answered by AI
Are people still being recruited for this experiment?
"This clinical trial, which was first posted on 1/15/2021 and most recently edited on 2/17/2022, is actively recruiting patients according to clinicaltrials.gov."
Answered by AI
What goals do researchers hope to achieve by conducting this trial?
"The primary purpose of this study, which will run for 6 weeks, is to Response rate (RR) (Phase II). Additionally, the trial will also monitor for secondary outcomes like RR (Phase I), defined as Will be assessed by RANO for MRI of glioblastoma. Response rate will be estimated, and a 95% confidence interval will be estimated using the Clopper-Pearson method., Visudyne blood levels (Phase I), summarized descriptively using mean, median, standard deviation, and range at each time point., and PFS (Phase I), defined as Will be assessed by RANO for MRI"
Answered by AI
What are some of the common conditions that Verteporfin is used to manage?
"Verteporfin is an effective intervention for pathologic myopia, subfoveal choroidal neovascularization (CNV), and age-related macular degeneration (AMD)."
Answered by AI
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