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Antifungal Agent

Ketoconazole for Brain Tumor

Q: To what extent has Ketoconazole been tested in other medical trials?

Presently, 10 research trials for Ketoconazole are ongoing. Of these initiatives, one is in its advanced Phase 3 phase. While the majority of studies occur in Rochester, <a href="https://www.withpower.com/clinical-trials/minnesota">Minnesota</a>, there are 28 total sites conducting experiments with this treatment.

Q: Is there an ongoing recruitment process for participants in this experiment?

Affirmative. Clinicaltrials.gov documents this clinical trial as currently recruiting participants, which began on March 13th 2019 and was most recently modified on October 6th 2022. A total of 19 patients are needed to complete the study at one medical site.

Q: Has this investigation ever been conducted before?

Presently, 10 clinical trials involving Ketoconazole are taking place in 23 cities spread across 3 nations. The initial trial for this medication was launched by Sanofi back in 2004 and featured 20 patients; the drug approval process concluded at that time. Since then, 121 additional studies have been completed.

Q: What medical ailments does Ketoconazole typically address?

Ketoconazole is the primary drug used to fight coccidioidomycosis, although it can be helpful in warding off other illnesses like paracoccidioidomycosis and tinea corporis caused by trichophyton mentagrophytes. It may also provide assistance with chromomycosis.

Q: What is the current enrollment rate for participants in this trial?

Affirmative, the clinical data posted on clinicaltrials.gov demonstrates that this medical investigation is actively searching for study participants. Initially posted on March 13th 2019 and most recently revised October 6th of 2022, 19 patients are needed to take part at 1 location.

Phase < 1

Recruiting

Led By Roy Strowd

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Histologically confirmed primary glioma including astrocytoma or oligodendroglioma of any World Health Organization grade with imaging findings consistent with recurrent or progressive disease (exploratory cohort). Patients with ependymoma will not be included.

Subjects must be undergoing surgical resection for clinical purposes with anticipated resection of at least 300 mg of tissue.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after surgery

Awards & highlights

Study Summary

This trial is testing ketoconazole as a possible treatment for brain tumors. Ketoconazole is an antifungal drug that may be able to block a protein, tGLI1 and may help to treat brain tumors.

Who is the study for?

This trial is for adults with recurrent glioma or breast cancer that has spread to the brain, who are scheduled for surgical tumor removal. Participants must have confirmed diagnoses, agree to use contraception, and be able to sign consent. Excluded are those allergic to ketoconazole, with certain heart conditions or liver issues, pregnant or breastfeeding women, and those on contraindicated medications.Check my eligibility

What is being tested?

The study tests how well ketoconazole works before surgery in patients with recurring brain tumors from glioma or metastatic breast cancer. Ketoconazole is an antifungal that may block a protein involved in tumor growth. The effectiveness and side effects will be evaluated pre-surgery.See study design

What are the potential side effects?

Ketoconazole can cause liver problems, hormone changes leading to gynecomastia (breast enlargement) in men or menstrual irregularities in women, skin reactions like itching or rash, headache, dizziness and gastrointestinal issues such as nausea.

Eligibility Criteria

Inclusion Criteria

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

Select...

My brain tumor is confirmed as glioma and is getting worse, but it's not ependymoma.

Select...

I am scheduled for surgery to remove a part of my body, expected to be at least 300 mg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after surgery for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

tGLI1 activation signature 8 (t-GAS 8)

Secondary outcome measures

Blood brain penetrance of ketoconazole in serum relative to enhancing brain tissue

Incidence of adverse events (AEs)

tGLI1 pathway activation

Other outcome measures

Changes in tGLI1 signaling pathway

Overall survival (OS)

Serum ketoconazole concentrations in Cerebrospinal Fluid (CSF)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (ketoconazole)Experimental Treatment2 Interventions

Patients receive ketoconazole PO QD on days 1-4 before standard surgery in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (standard surgery)Active Control1 Intervention

Patients undergo standard surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketoconazole

2011

Completed Phase 3

~1420

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,886 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,004,248 Total Patients Enrolled

34 Trials studying Breast Cancer

5,047 Patients Enrolled for Breast Cancer

Roy StrowdPrincipal InvestigatorWake Forest University Health Sciences

2 Previous Clinical Trials

75 Total Patients Enrolled

Media Library

Ketoconazole (Antifungal Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03796273 — Phase < 1

Breast Cancer Research Study Groups: Arm II (standard surgery), Arm I (ketoconazole)

Breast Cancer Clinical Trial 2023: Ketoconazole Highlights & Side Effects. Trial Name: NCT03796273 — Phase < 1

Ketoconazole (Antifungal Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03796273 — Phase < 1

Frequently Asked Questions

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

To what extent has Ketoconazole been tested in other medical trials?

"Presently, 10 research trials for Ketoconazole are ongoing. Of these initiatives, one is in its advanced Phase 3 phase. While the majority of studies occur in Rochester, Minnesota, there are 28 total sites conducting experiments with this treatment."

Answered by AI

Is there an ongoing recruitment process for participants in this experiment?

"Affirmative. Clinicaltrials.gov documents this clinical trial as currently recruiting participants, which began on March 13th 2019 and was most recently modified on October 6th 2022. A total of 19 patients are needed to complete the study at one medical site."

Answered by AI

Has this investigation ever been conducted before?

"Presently, 10 clinical trials involving Ketoconazole are taking place in 23 cities spread across 3 nations. The initial trial for this medication was launched by Sanofi back in 2004 and featured 20 patients; the drug approval process concluded at that time. Since then, 121 additional studies have been completed."

Answered by AI

What medical ailments does Ketoconazole typically address?

"Ketoconazole is the primary drug used to fight coccidioidomycosis, although it can be helpful in warding off other illnesses like paracoccidioidomycosis and tinea corporis caused by trichophyton mentagrophytes. It may also provide assistance with chromomycosis."

Answered by AI

What is the current enrollment rate for participants in this trial?

"Affirmative, the clinical data posted on clinicaltrials.gov demonstrates that this medical investigation is actively searching for study participants. Initially posted on March 13th 2019 and most recently revised October 6th of 2022, 19 patients are needed to take part at 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma or Breast Cancer Brain Metastases

2019. "Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma or Breast Cancer Brain Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03796273.

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