Ketoconazole + Posaconazole for Recurrent Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
High-grade gliomas are the most common and aggressive type of brain cancer. Scientists don't fully understand how they grow and spread, and treatments haven't improved much in recent years. However, it's been discovered that these cancers rely heavily on using glucose to maintain their cancerous traits. In lab tests, drugs from the azole class, which target a key step in glucose metabolism, have shown promise in reducing tumor growth in these cancers. Researchers now want to test two of these drugs, ketoconazole and posaconazole, in patients with recurring high-grade gliomas. A small group of these patients will receive either one or several doses of these drugs before undergoing surgery. During the surgery, doctors will measure how much of the drug is present in the brain. They will also study how the drug affects the tumor, particularly its ability to process glucose. This research aims to provide initial insights into how these drugs work in patients with this type of brain cancer, which could guide future research and treatment strategies.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications that interact with the study drugs, such as some anti-seizure medications, certain antibiotics, and drugs that affect heart rhythm. If you're on any of these, you may need to switch to alternatives before joining the trial.
How is the drug combination of Ketoconazole and Posaconazole unique for treating recurrent brain cancer?
The combination of Ketoconazole and Posaconazole is unique for treating recurrent brain cancer because it involves two antifungal drugs that may have a novel mechanism of action against cancer cells, unlike traditional chemotherapy or radiation treatments. This approach is different from standard treatments, which often do not include antifungal agents.12345
What data supports the effectiveness of the drug combination Ketoconazole and Posaconazole for recurrent brain cancer?
The CUSP9 protocol, which includes Ketoconazole, has been proposed to improve outcomes in recurrent glioblastoma by using a combination of drugs that are well-tolerated and interfere with glioblastoma growth mechanisms. This suggests that Ketoconazole may have potential benefits in treating recurrent brain cancer when used as part of a multi-drug regimen.15678
Who Is on the Research Team?
Gelareh Zadeh, MD, PhD
Principal Investigator
University Health Network/Toronto Western Hospital
Are You a Good Fit for This Trial?
Adults over 18 with recurrent high-grade gliomas (a type of aggressive brain cancer) who need surgery can join. They should be relatively stable (KPS ≥ 60%, ECOG ≤ 2), expected to live more than 12 weeks, and have good liver and kidney function. Women and men must use birth control during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a single dose or repeated doses of ketoconazole or posaconazole before surgery
Surgery
Surgery is performed to measure drug concentration in the brain and assess biological effects on the tumor
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ketoconazole
- Posaconazole
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor