Actively Recruiting
Verteporfin for the Treatment of Recurrent High Grade EGFR-Mutated Glioblastoma
Led by Emory University · Updated on 2025-02-25
24
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Verteporfin for the Treatment of Recurrent High Grade EGFR-Mutated Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrent or progressive grade 4 glioma (glioblastoma) after standard first-line therapy including radiation and temozolomide
- Tumors must show mutant or amplified EGFR confirmed by standard mutation analysis
- Evidence of tumor progression on MRI, distinguishing true progression from radiation-related changes
- Participants may be receiving bevacizumab and may continue it during the study
- Willingness to have central venous access placed for repeated intravenous treatments
- ECOG performance status of 0 to 3, with stable condition if status is 2 or 3
- Medical comorbidities (except neurological) must be grade 2 or less
- Grade 3 neurological comorbidities due to brain pathology are allowed
- Expected ability to complete at least 6 weeks of treatment before significant decline
- At least 7 days since stopping prior chemotherapy for glioma
- Prior brain radiation completed at least 90 days before study treatment
- At least 21 days since major surgery
- May continue using Novo-tumor treating fields therapy (Optune) if already in use and willing
- Must sign written informed consent
- Female participants of child-bearing potential must have a negative pregnancy test before therapy
- Both females of child-bearing potential and men must agree to use adequate contraception during and 8 weeks after study participation
You will not qualify if you...
- Clinical progression without MRI evidence of tumor progression
- Edema likely due to late radiation effect without true tumor progression
- Pregnant or breastfeeding women
- Baseline comorbidities or lab abnormalities of grade 3 or worse (except alopecia and neurological symptoms from tumor)
- Inability to comply with study safety monitoring
- Illness or conditions preventing safe study participation or consent
- Hereditary porphyria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
W
William L. Read, MD
CONTACT
W
William L Read, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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