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Antifungal Agent

Ketoconazole for Brain Cancer

Q: Has any similar research been conducted prior to this trial?

Since Sanofi's inaugural experiment in 2004, the usage of ketoconazole has been explored further. After its N/A drug approval following that first trial with 20 participants, presently 10 active studies are being conducted across 23 cities and 3 nations.

Q: Have other researchers studied the effectiveness of Ketoconazole?

At this moment, 10 trials for ketoconazole are in progress with 1 of these studies at the Phase 3 stage. The majority of research is taking place around Rochester, <a href="https://www.withpower.com/clinical-trials/minnesota">Minnesota</a> but there are 28 locations across the country currently conducting ketoconazole clinical trials.

Q: How many research subjects are taking part in this experiment?

Affirmative. According to the information on clinicaltrials.gov, this healthcare initiative is currently looking for participants; it was first posted on May 12th 2022 and last updated on July 12th 2022. The medical trial needs 5 individuals from one centre in order to progress.

Q: What symptoms does Ketoconazole typically address?

Ketoconazole is utilized to address coccidioimycosis and other fungal infections, such as paracoccidiodomycosis, trichophyton mentagrophytes-induced tinea corporis, and chromomycosis.

Q: Are there any available openings for participants in this experiment?

Per the information posted on clinicaltrials.gov, this medical trial is actively seeking participants for enrollment. The study was initially announced on May 12th 2022 and has undergone a recent update as of July 12th 2022.

Q: What is the objective of this medical research endeavor?

The purpose of this inquiry, which will be monitored over a 24-hour period following biopsy or resection surgery, is to discern the half-life pharmacodynamics when considering drug concentration. Additional objectives include measuring cell death in tumors via TUNEL staining and correlating ketoconazole's effect on tumor proliferation with Ki-67 indices. Additionally, mass spectrometry shall assess lactate concentration within dialysate fluid as another secondary outcome.

Phase < 1

Recruiting

Led By Alireza Mansouri

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

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours after biopsy or tumor resection

Awards & highlights

Study Summary

This trial is testing whether ketoconazole can effectively treat brain tumors by entering and stopping the cells from dividing.

Who is the study for?

Adults with high-grade gliomas needing surgery can join this trial if they're in good enough health, can swallow pills, and have a life expectancy over 12 weeks. They must agree to use birth control and be able to follow the study plan. People who've had bad reactions to similar drugs, are pregnant or breastfeeding, have certain illnesses like hepatitis or psychiatric conditions that could affect participation, or take specific medications that interact with ketoconazole cannot participate.Check my eligibility

What is being tested?

The trial is testing whether ketoconazole, a drug normally used for fungal infections, can reach brain tumors in sufficient amounts to stop tumor growth. The goal is to see if it's effective against brain cancer cells and should be researched further as a treatment option.See study design

What are the potential side effects?

Ketoconazole may cause liver problems (like changes in enzyme levels), allergic reactions for those sensitive to azoles, issues related to adrenal gland function (like Addison's disease), and potentially interfere with other medications by affecting their metabolism.

Eligibility Criteria

Inclusion Criteria

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

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

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I am 18 years old or older.

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My liver tests (ALT, AST, ALP) are within normal range.

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My kidney function, measured by eGFR, is within the normal range.

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I can care for myself but may need occasional help.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Establish drug concentration versus time profile yielding half-life pharmacodynamics

Establish drug concentration versus time profile yielding maximum plasma concentration (Cmax)

Secondary outcome measures

Concentration of lactate measured using mass spectrometry in resected tumor tissue

Concentration of pyruvate, measured using mass spectrometry in resected tumor tissue

Correlation of concentration versus time profile of ketoconazole , compared to that of lactate - measured using mass spectrometry over 24 hours

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: KetoconazoleExperimental Treatment1 Intervention

Participants will be taking 400 mg of the study drug (two 200 mg tablets) by mouth twice 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) and in the evening after their biopsy or surgery (after 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketoconazole

2011

Completed Phase 3

~1420

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

494 Previous Clinical Trials

2,798,837 Total Patients Enrolled

3 Trials studying Glioblastoma

98 Patients Enrolled for Glioblastoma

Alireza MansouriPrincipal InvestigatorMilton S. Hershey Medical Center

Media Library

Ketoconazole (Antifungal Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04869449 — Phase < 1

Glioblastoma Research Study Groups: Ketoconazole

Glioblastoma Clinical Trial 2023: Ketoconazole Highlights & Side Effects. Trial Name: NCT04869449 — Phase < 1

Ketoconazole (Antifungal Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04869449 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has any similar research been conducted prior to this trial?

"Since Sanofi's inaugural experiment in 2004, the usage of ketoconazole has been explored further. After its N/A drug approval following that first trial with 20 participants, presently 10 active studies are being conducted across 23 cities and 3 nations."

Answered by AI

Have other researchers studied the effectiveness of Ketoconazole?

"At this moment, 10 trials for ketoconazole are in progress with 1 of these studies at the Phase 3 stage. The majority of research is taking place around Rochester, Minnesota but there are 28 locations across the country currently conducting ketoconazole clinical trials."

Answered by AI

How many research subjects are taking part in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this healthcare initiative is currently looking for participants; it was first posted on May 12th 2022 and last updated on July 12th 2022. The medical trial needs 5 individuals from one centre in order to progress."

Answered by AI

What symptoms does Ketoconazole typically address?

"Ketoconazole is utilized to address coccidioimycosis and other fungal infections, such as paracoccidiodomycosis, trichophyton mentagrophytes-induced tinea corporis, and chromomycosis."

Answered by AI

Are there any available openings for participants in this experiment?

"Per the information posted on clinicaltrials.gov, this medical trial is actively seeking participants for enrollment. The study was initially announced on May 12th 2022 and has undergone a recent update as of July 12th 2022."

Answered by AI

What is the objective of this medical research endeavor?

"The purpose of this inquiry, which will be monitored over a 24-hour period following biopsy or resection surgery, is to discern the half-life pharmacodynamics when considering drug concentration. Additional objectives include measuring cell death in tumors via TUNEL staining and correlating ketoconazole's effect on tumor proliferation with Ki-67 indices. Additionally, mass spectrometry shall assess lactate concentration within dialysate fluid as another secondary outcome."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas

Alireza Mansouri 2022. "Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04869449.

All > Glioblastoma Baltimore