Azoles Targeting Recurrent High Grade Gliomas

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About 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

Qualifiers

Age ≥18 years

Evidence of recurrent HGG that in the opinion of the treating team does not represent pseudoprogression and would require surgical resection

Karnofsky Performance Score (KPS) ≥ 60%

ECOG ≤ 2

Disqualifiers

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

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

Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous azole class drugs for a parasitic infection

Patients with a history of acute or chronic hepatitis

Trial design

Treatments tested in this trial

  • Ketoconazole (KCZ)
  • Posaconazole (PCZ)

Treatment groups

30 Participants
are divided into 4 treatment groups