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Azole Antifungal
Posaconazole (PCZ) for Brain Cancer
Phase < 1
Waitlist Available
Led By Gelareh Zadeh, MD, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following either single dose regimen(4-24hours prior to surgery) or repeated dose regimen of kcz(for 2-5 days) or pcz(for 7-10 days)
Awards & highlights
Study Summary
This trial aims to test two drugs, ketoconazole and posaconazole, in patients with recurring high-grade gliomas, a type of aggressive brain cancer. These drugs target glucose metabolism, which is
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing Ketoconazole (KCZ) and Posaconazole (PCZ), two drugs that may interfere with the tumor's glucose use, potentially slowing its growth. Participants will receive doses before their scheduled surgeries where drug levels in the brain and effects on the tumor will be assessed.See study design
What are the potential side effects?
Possible side effects from KCZ or PCZ include issues affecting liver function, changes in blood potassium, calcium, magnesium levels for PCZ users; renal function concerns for KCZ users; gastrointestinal symptoms; fatigue; allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ following either single dose regimen(4-24hours prior to surgery) or repeated dose regimen of kcz(for 2-5 days) or pcz(for 7-10 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following either single dose regimen(4-24hours prior to surgery) or repeated dose regimen of kcz(for 2-5 days) or pcz(for 7-10 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intratumoral concentrations of KCZ or PCZ
Plasma concentrations of KCZ or PCZ
Secondary outcome measures
Assess Hexokinase 2 activity
Assess the biological effects of KCZ or PCZ on metabolites within the glycolytic pathway
assess biological effects of KCZ or PCZ on tumor angiogenesis
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Posaconazole (PCZ) Single Dose groupExperimental Treatment1 Intervention
Single dose 300 mg delayed release oral tablets 4-24 hours prior to surgery
Group II: Posaconazole (PCZ) Repeated Dose groupExperimental Treatment1 Intervention
300 mg delayed release oral tablets twice a day (BID) for day 1; every day thereafter is a single dose of 300 mg delayed release oral tablets. Total treatment time is 7-10 days prior to surgery.
Group III: Ketoconazole (KCZ) Single Dose GroupExperimental Treatment1 Intervention
Single dose 400mg oral tablets 4-24 hours prior to surgery
Group IV: Ketoconazole (KCZ) Repeated Dose GroupExperimental Treatment1 Intervention
400mg oral tablets twice a day (BID) for 2-5 days prior to surgery
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,465 Previous Clinical Trials
483,659 Total Patients Enrolled
Gelareh Zadeh, MD, PhDPrincipal InvestigatorUniversity Health Network/Toronto Western Hospital
1 Previous Clinical Trials
50 Total Patients Enrolled
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