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Azole Antifungal

Posaconazole for Glioblastoma

Phase < 1

Recruiting

Led By Alireza Mansouri, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky Performance Score (KPS) ≥ 60%

ECOG ≤ 2

Must not have

Patients who are not capable of understanding the consent form and would need a legally authorized representative

Patients who are currently taking medications that induce the metabolism of posaconazole, such as isoniazid, nevirapine, rifamycins (such as rifabutin, rifampin), or St. John's wort and cannot be safely discontinued off of them for the duration of the trial (for study drug arm only)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to visit 7 (14 days +/- 7 days post-op)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a drug already used for fungal infections can also enter and stop brain tumor cells from dividing.

Who is the study for?

Adults over 18 with glioblastoma, a type of brain tumor, who are expected to live more than 12 weeks and need surgery. They must be able to swallow pills, have good liver function, use birth control if needed, understand the study consent form, and follow the treatment plan. People can't join if they're on certain drugs that affect posaconazole or have specific health issues like severe allergies to azoles.

What is being tested?

The trial is testing whether Posaconazole, a drug normally used for fungal infections, can reach high enough levels in brain tumors to stop cancer cells from growing. It's being considered as a new treatment option for glioblastoma because current treatments are limited.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of Posaconazole may include headache, nausea, vomiting, diarrhea and abdominal pain based on its use as an antifungal medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself but may need occasional help.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need someone to help me understand and consent to medical procedures.

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I am not taking medication like isoniazid or St. John's wort that cannot be stopped for the trial.

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I am not on any seizure medications that affect liver enzymes or can switch to ones that don't.

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I had severe reactions like low white blood cell counts from previous azole drugs for parasites.

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I do not have any chronic illnesses like hepatitis or severe mental health issues that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to visit 7 (14 days +/- 7 days post-op)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to visit 7 (14 days +/- 7 days post-op)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to visit 7 (14 days +/- 7 days post-op) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Establish the neuro-pharmacokinetic profile of posaconazole, using microdialysis catheters

Secondary study objectives

Correlation of posaconazole pharmacokinetic profile with that of lactate using MDC

Correlation of posaconazole pharmacokinetic profile with that of pyruvate using MDC

Evaluate posaconazole angiogenesis in tumor tissue

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PosaconazoleExperimental Treatment1 Intervention

Participants will be taking 300 mg of the study drug (three 100 mg tablets) by mouth twice a day the first day and then 300 mg once a day until the day of biopsy or surgery. On the day of biopsy or surgery, participants will take their medication the morning of their biopsy or surgery (before the operation). Participants will then take the last dose of the medication in the morning of the day after their biopsy or surgery. Participants will be given 12 days' worth of the study drug (pills) and verbally instructed how and when to take them.

Group II: ControlActive Control1 Intervention

Participants will not undergo any intervention.

0 / 8Eligibility criteria met