Posaconazole for Glioblastoma
Trial Summary
Will I have to stop taking my current medications?
You may need to stop taking certain medications if they interfere with the study drug, posaconazole. Specifically, if you are taking medications like metronidazole, certain anti-convulsants, or drugs that affect posaconazole's metabolism, you might need to switch to alternatives or stop them. It's best to discuss your current medications with the study team to see if any changes are needed.
How does the drug Posaconazole differ from other treatments for glioblastoma?
Posaconazole is unique because it is primarily an antifungal drug with a broad spectrum of activity, and it is being explored for glioblastoma, a type of brain cancer, which is not its usual use. Its novel application in glioblastoma may involve its ability to penetrate tissues effectively, but this is different from standard cancer treatments that typically target cancer cells directly.12345
What is the purpose of this trial?
This research is being done to find out if the study drug (posaconazole) can enter brain tumors at a high enough amount to stop the tumor cells from dividing. Posaconazole is a drug which doctors already use for fungal infections and is thought to be able to effect tumor cells. As treatments for this type of brain tumor are limited, it is hoped that the results of this study will help to determine if the study drug should be studied further as a possible treatment.
Research Team
Alireza Mansouri, MD
Principal Investigator
Milton S. Hershey Medical Center
Eligibility Criteria
Adults over 18 with glioblastoma, a type of brain tumor, who are expected to live more than 12 weeks and need surgery. They must be able to swallow pills, have good liver function, use birth control if needed, understand the study consent form, and follow the treatment plan. People can't join if they're on certain drugs that affect posaconazole or have specific health issues like severe allergies to azoles.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 300 mg of posaconazole twice on the first day, then 300 mg once daily until the day after biopsy or surgery
Surgery/Biopsy
Participants undergo biopsy or tumor resection, with microdialysis catheters placed for pharmacokinetic assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pharmacokinetic and pharmacodynamic assessments
Treatment Details
Interventions
- Posaconazole
Posaconazole is already approved in European Union, United States, Canada for the following indications:
- Invasive Aspergillus infections
- Candidemia
- Oropharyngeal Candidiasis
- Invasive Aspergillus infections
- Candidemia
- Oropharyngeal Candidiasis
- Invasive Aspergillus infections
- Candidemia
- Oropharyngeal Candidiasis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator