Verteporfin (Visudyne) for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called Visudyne (Verteporfin) to evaluate its effectiveness against glioblastoma, a type of brain cancer, particularly when it recurs after treatment. Although Visudyne is typically used for eye diseases, the study aims to determine if it can kill cancer cells similarly to chemotherapy. Suitable participants have recurrent glioblastoma with a specific gene change (EGFR mutation) and have already undergone standard treatments like radiation and temozolomide. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must stop any prior chemotherapy treatments for glioma at least 7 days before starting the study. If you are on bevacizumab, you may continue it while participating in the trial.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that verteporfin is usually well-tolerated for eye diseases. In animal studies, verteporfin helped animals live longer, which is encouraging for its potential use in humans. These results have led to more testing in clinical trials for other conditions, such as glioblastoma. In these trials, verteporfin slowed tumor cell movement and may help patients live longer.
Since the FDA has already approved verteporfin for eye diseases, there is some confidence in its safety. However, its use for glioblastoma remains under study. This trial aims to find the best dose with the fewest side effects. Participants might experience different reactions, but ensuring safety remains a primary focus of the trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for glioblastoma, which typically involve surgery, radiation, and chemotherapy, Verteporfin offers a unique approach. Verteporfin is known for its use in photodynamic therapy for eye conditions, but in glioblastoma, it targets abnormal blood vessels within the tumor. This targeted action can potentially disrupt the tumor's blood supply, thus inhibiting its growth. Researchers are excited about Verteporfin because it introduces a novel mechanism of action, providing an alternative pathway to attack this aggressive brain cancer.
What evidence suggests that Visudyne might be an effective treatment for glioblastoma?
Research has shown that verteporfin, which participants in this trial will receive, may help treat glioblastoma, a type of brain cancer. Studies have found that verteporfin can slow the growth and spread of cancer cells in the lab. Unlike its use in treating eye diseases, verteporfin can kill these cancer cells without needing light. It also helps stop tumor cells from moving and improved survival in animal studies. These findings suggest that verteporfin might be useful in managing recurring high-grade glioblastoma, especially in people with certain genetic changes.12367
Who Is on the Research Team?
William L Read, MD
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive verteporfin intravenously 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.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 12 weeks.
Long-term follow-up
Participants are monitored for overall survival and progression-free survival up to 2 years.
What Are the Treatments Tested in This Trial?
Interventions
- Verteporfin
Verteporfin is already approved in United States, European Union for the following indications:
- Predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration
- Predominantly classic subfoveal choroidal neovascularization due to pathologic myopia
- Predominantly classic subfoveal choroidal neovascularization due to presumed ocular histoplasmosis
- Predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration
- Predominantly classic subfoveal choroidal neovascularization due to pathologic myopia
- Predominantly classic subfoveal choroidal neovascularization due to presumed ocular histoplasmosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator