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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to visit 7 (14 days +/- 7 days post-op)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Establish the neuro-pharmacokinetic profile of posaconazole, using microdialysis catheters
Secondary outcome measures
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,122 Total Patients Enrolled
322 Trials studying Glioblastoma
23,105 Patients Enrolled for Glioblastoma
Milton S. Hershey Medical CenterLead Sponsor
495 Previous Clinical Trials
2,798,864 Total Patients Enrolled
3 Trials studying Glioblastoma
93 Patients Enrolled for Glioblastoma
Alireza Mansouri, MDPrincipal InvestigatorMilton S. Hershey Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot switch from metronidazole to another antibiotic more than 7 days before starting posaconazole.My liver tests are within the normal range required by the study.I have a history of hepatitis.I have a history of Addison's disease or other adrenal issues.My stomach produces little or no acid.I can swallow pills.I need someone to help me understand and consent to medical procedures.I am not taking medication like isoniazid or St. John's wort that cannot be stopped for the trial.My doctor recommends surgery for my brain tumor.I can care for myself but may need occasional help.I can take care of myself and am up and about more than 50% of my waking hours.I agree to use effective birth control or abstain from sex during the study.I am 18 years old or older.I am not on any seizure medications that affect liver enzymes or can switch to ones that don't.I had severe reactions like low white blood cell counts from previous azole drugs for parasites.I do not have any chronic illnesses like hepatitis or severe mental health issues that would stop me from following the study's requirements.I am taking medication that may interact with posaconazole.
Research Study Groups:
This trial has the following groups:- Group 1: Posaconazole
- Group 2: Control
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum number of participants that this experiment can hold?
"Yes, according to clinicaltrials.gov, this medical study is recruiting individuals for participation as of now. It was first posted on February 8th 2022 and updated most recently on August 5th 2022. The research requires only 10 patients from 1 location."
Answered by AI
Could you provide examples of other experiments using Posaconazole Pill?
"As of now, nine research studies are in progress concerning posaconazole pill. Two of which have progressed to phase 3 trials. Owing to its prevalence, 110 different sites across Brussels and Bruxelles-Capitale Region De are running clinical tests related to this medication."
Answered by AI
What therapeutic purposes is Posaconazole Pill commonly used for?
"Posaconazole Pill is conventionally used to treat HIV, yet it has also been clinically proven to combat candidiasis and other immunocompromised states as well as prophylactically protecting patients from fungal infections."
Answered by AI
Are there any vacancies this study has yet to fill?
"According to clinicaltrials.gov, this scientific investigation is currently seeking participants. The trial was initially listed on February 8th 2022 and the details were most recently revised on August 5th 2022."
Answered by AI
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