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Antifungal Agent
Ketoconazole for Brain Tumor
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 belowSelect...
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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,727 Previous Clinical Trials
40,966,058 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Wake Forest University Health SciencesLead Sponsor
1,252 Previous Clinical Trials
1,010,698 Total Patients Enrolled
35 Trials studying Breast Cancer
5,087 Patients Enrolled for Breast Cancer
Roy StrowdPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
75 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take ketoconazole due to health reasons.Your heart's electrical activity, as measured by EKG, shows a prolonged QTc interval.I have had radiation, chemotherapy, or surgery before.I am not pregnant or breastfeeding.I can understand and am willing to sign the consent form approved by the review board.I am willing to stop taking certain medications for 7 days before joining the trial.You have had a positive pregnancy test in the past 21 days.You had an allergic reaction or couldn't tolerate ketoconazole before.I do not have liver cirrhosis.This criterion does not apply to me.My brain tumor is confirmed as glioma and is getting worse, but it's not ependymoma.I am scheduled for surgery to remove a part of my body, expected to be at least 300 mg.I have active hepatitis.I have breast cancer that has spread to my brain.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (standard surgery)
- Group 2: Arm I (ketoconazole)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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