Ketoconazole + Posaconazole for Recurrent Brain Cancer

Recruiting in Palo Alto (17 mi)

Overseen byGelareh Zadeh, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

Life expectancy greater than 12 weeks

Potassium, calcium, and magnesium within normal limits (PCZ cohort)

I can care for myself but may need occasional help.

+9 more

Exclusion Criteria

I have not taken azole medications in the last 3 months.

Patients may not be receiving any other investigational agents while on study

Patients who have known allergy to KCZ, PCZ, or other azoles

+15 more

Participant Groups

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.

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