Overseen ByWilliam L Read, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Emory University
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?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.
What makes the drug Verteporfin unique for treating glioblastoma?
Verteporfin is unique for treating glioblastoma because it is primarily used as a photosensitizer in photodynamic therapy for eye conditions, and its application in brain tumors like glioblastoma is novel, potentially offering a different mechanism of action compared to traditional chemotherapy or radiation.
12345Will 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.
Eligibility Criteria
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
I am willing to have a central venous access device installed for my treatment.
I have a grade 4 glioma and have undergone standard treatment with radiation and temozolomide.
My tumor has a mutation or high levels of EGFR.
My health issues, except for any nerve-related ones, are mild.
Exclusion Criteria
I do not have hereditary porphyria.
Participant Groups
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.
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.
Verteporfin is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Visudyne for:
- 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
🇪🇺 Approved in European Union as Visudyne for:
- 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
Research locations nearbySelect from list below to view details:
Emory University Hospital/Winship Cancer InstituteAtlanta, GA
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Who is running the clinical trial?
Emory UniversityLead Sponsor
National Cancer Institute (NCI)Collaborator
References
The chemotherapeutic response of a murine (VM) model of human glioma. [2019]Using a cell line derived from the VM spontaneous murine astrocytoma, a reliable in vitro-in vivo model of human malignant glioma has been developed. In this paper we examine the effects of cytotoxic drugs with known activity against other animal brain tumour models and human disease on the in vivo VM model. The drugs BCNU, CCNU and vincristine produced significant volume reduction in tumours growing at a subcutaneous location in syngeneic animals. Procarbazine was ineffective. Similarly, BCNU, CCNU and vincristine produced small but statistically significant increases in survival of VM mice bearing the intracerebral tumour, but procarbazine was again ineffective. The modest, but significant, response of the VM model to the nitrosoureas mimics the human situation more closely than previously described animal models.
Spiromustine and intracarotid artery cisplatin in the treatment of glioblastoma multiforme. [2019]Glioblastoma multiforme is a highly malignant and rapid-growing primary brain tumor. It constitutes one-fourth of all intracranial tumors and about half of all gliomas. Survival rate following conventional treatment is only 12 to 18 months. At the National Institutes of Health, two promising therapies are currently undergoing clinical trials. Spirohydantoin mustard (spiromustine) is a combination of a nitrogen mustard and a derivative of phenytoin, an anticonvulsant drug that rapidly penetrates the blood-brain barrier and localizes in brain tumors. Intracarotid administration of cis-diamminedichloroplatinum (cisplatin) increases drug delivery to the tumor and, through hemodialysis, systemic exposure is reduced. Nursing management of patients receiving these two agents requires precise planning and implementation of an individualized plan of care to ensure a successful chemotherapeutic regimen.
Phase II Study of Bevacizumab and Vorinostat for Patients with Recurrent World Health Organization Grade 4 Malignant Glioma. [2019]Combination regimen with bevacizumab (BEV) and vorinostat is well tolerated in patients with recurrent glioblastoma.Treatment of recurrent glioblastoma remains challenging as this study and others attempt to improve progression-free survival and overall survival with BEV-containing regimens.
A phase I study of vistusertib (dual mTORC1/2 inhibitor) in patients with previously treated glioblastoma multiforme: a CCTG study. [2021]The PI3K/AKT/mTOR pathway activation plays a central role in glioblastoma multiforme (GBM) development and progression, and in resistance to anti-cancer therapies. Inhibition of the PI3K pathway has been shown to sensitize cultured glioma cells and tumor xenografts to the effects of temozolomide (TMZ) and radiation. Vistusertib is an oral inhibitor of mTORC1/2 complexes. The primary objective of this Canadian Cancer Trials Group phase I study was to determine the recommended phase II dose (RP2D) of vistusertib in patients with GBM receiving TMZ at first progression following primary treatment. Vistusertib was administered at a starting dose of 100 mg bid 2 days on/5 days off weekly with TMZ 150 mg/m2 daily for 5 days/28-days cycle. Dose escalation was according to a 3 + 3 design. Secondary objectives included assessment of vistusertib safety and toxicity profile, and preliminary efficacy. 15 patients were enrolled in the study (median age 66 (range 51-77), females 8). Vistusertib 125 mg BID in combination with TMZ 150 mg/m2 daily for 5 days was well tolerated. Vistusertib treatment-related adverse events were generally grade 1-2, with the most frequently reported being fatigue, gastrointestinal symptoms, and rash. Of 13 response evaluable patients, 1 patient (8%) had a partial response ongoing at 7.6 months of follow-up, and 5 patients had stable disease (38%) as best response (median duration 9.6 months, range 3.7-not yet reached). Six-month progression-free survival (PFS) rate was 26.6%. Combination of vistusertib with TMZ in GBM patients at first recurrence demonstrated a favorable safety profile at the tested dose levels.
Transient Hepatotoxicity Induced by Vinblastine in a Young Girl with Chiasmatic Low Grade Glioma. [2021]Vinblastine (VBL) is a cytostatic drug frequently applied in children with lymphoma and progressive low-grade glioma (LGG), with hematotoxicity as the main side effect.