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Azole Antifungal

Ketoconazole + Posaconazole for Recurrent 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) compared to archive tumor tissue from baseline

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

All Individual Drugs Already Approved

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.

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.

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) compared to archive tumor tissue from baseline

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) compared to archive tumor tissue from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) compared to archive tumor tissue from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial 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

Do I qualify?Apply below to find out