What side effects are associated with this type of intervention?

Common treatments for Glioblastoma that inhibit tumor cell division, such as temozolomide, often have side effects including nausea, vomiting, fatigue, and myelosuppression (reduced bone marrow activity leading to fewer blood cells). Other potential side effects include headaches, constipation, and an increased risk of infections due to lowered white blood cell counts. These treatments aim to target rapidly dividing tumor cells but can also affect normal, healthy cells, leading to these adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for glioblastoma that inhibit tumor cell division include temozolomide, a standard chemotherapy drug that interferes with DNA replication in cancer cells, and bevacizumab, which inhibits angiogenesis, thereby reducing the tumor's blood supply and growth. Other investigational treatments, such as ONC201, are being studied for their potential to target specific pathways involved in tumor cell metabolism and stress response. These treatments aim to improve outcomes by targeting the mechanisms that allow glioblastoma cells to proliferate.

What other types of research exist?

Promising alternatives to Ketoconazole for Glioblastoma patients include: 1) Temozolomide, which has been successful in combination with radiotherapy. 2) PD-1 inhibitors like Nivolumab, which have shown activity in recurrent cases. 3) Bevacizumab, an anti-angiogenic agent used for progressive Glioblastoma. 4) mTOR inhibitors such as Everolimus, which have demonstrated inhibitory effects on tumor growth. 5) Small molecule tyrosine kinase inhibitors like Afatinib and Erlotinib, although their clinical roles are still being established.

← Back to Search

Antifungal Agent

Ketoconazole for Brain Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for Glioblastoma primarily aim to inhibit tumor cell division and growth. Temozolomide, a standard chemotherapy agent, works by methylating DNA, which leads to DNA damage and triggers cell death in rapidly dividing tumor cells. Radiation therapy damages the DNA of cancer cells, preventing them from replicating. Targeted therapies, such as those inhibiting specific molecular pathways involved in cell proliferation, are also being explored. These treatments are crucial for Glioblastoma patients as they target the aggressive nature of the tumor, aiming to slow its progression and improve survival rates.

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

Must not have

Patients with a history of acute or chronic hepatitis

Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous azole class drugs for a parasitic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours after biopsy or tumor resection

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing posaconazole, a drug usually used for fungal infections, to see if it can help treat brain tumors by stopping the tumor cells from growing. The study focuses on patients with limited treatment options for their brain tumors.

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.

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.

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

Select...

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

Select...

I am 18 years old or older.

Select...

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

Select...

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

Select...

I can care for myself but may need occasional help.

Exclusion Criteria

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

Select...

I have a history of hepatitis.

Select...

I had severe reactions like low white blood cell counts from previous fungal infection treatments.

Select...

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Select...

I need someone legally authorized to understand and consent for me.

Select...

I am on medication for seizures that affects drug metabolism and cannot switch to alternatives.

Select...

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

Select...

My stomach does not produce enough acid.

Select...

I have a history of Addison's disease or another type of adrenal insufficiency.

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 drug concentration versus time profile yielding half-life pharmacodynamics

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Glioblastoma primarily aim to inhibit tumor cell division and growth. Temozolomide, a standard chemotherapy agent, works by methylating DNA, which leads to DNA damage and triggers cell death in rapidly dividing tumor cells. Radiation therapy damages the DNA of cancer cells, preventing them from replicating. Targeted therapies, such as those inhibiting specific molecular pathways involved in cell proliferation, are also being explored. These treatments are crucial for Glioblastoma patients as they target the aggressive nature of the tumor, aiming to slow its progression and improve survival rates.