Posaconazole Pill for Glioblastoma

Phase-Based Estimates
1
Effectiveness
1
Safety
Penn State Milton S Hershey Medical Center, Hershey, PA
Glioblastoma+3 More
Posaconazole Pill - Drug
Eligibility
18+
All Sexes
Eligible conditions
Glioblastoma

Study Summary

This study is evaluating whether a drug which is already used to treat fungal infections may be able to help treat brain tumors.

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Eligible Conditions

  • Glioblastoma
  • Glioblastoma Multiforme (GBM)
  • Glioblastoma Multiforme, Adult
  • Glioblastoma Multiforme of Brain

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Posaconazole Pill will improve 1 primary outcome and 7 secondary outcomes in patients with Glioblastoma. Measurement will happen over the course of Over the same 24-hour period used to measure the concentration of drug.

Collected over a 24-hour period after surgery (biopsy or resection)
Establish the neuro-pharmacokinetic profile of posaconazole, using microdialysis catheters
Over the same 24-hour period used to measure the concentration of drug
Correlation of posaconazole pharmacokinetic profile with that of lactate using MDC
Correlation of posaconazole pharmacokinetic profile with that of pyruvate using MDC
Hour 24
Evaluate posaconazole angiogenesis in tumor tissue
Evaluate posaconazole effect on Hexokinase 2 activity within tumor tissue
Evaluate posaconazole on cell death in tumor tissue
Evaluate posaconazole on tumor proliferation in tumor tissue
Day 14
Evaluate tolerability of preoperative steady-state dosing of Posaconazole

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Posaconazole

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. Posaconazole Pill is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Posaconazole
Drug
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to visit 7 (14 days +/- 7 days post-op)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from baseline to visit 7 (14 days +/- 7 days post-op) for reporting.

Who is running the study

Principal Investigator
A. M.
Prof. Alireza Mansouri, Assistant Professor, Department of Neurosurgery
Milton S. Hershey Medical Center

Closest Location

Penn State Milton S Hershey Medical Center - Hershey, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Glioblastoma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adequate liver function defined as ALT, AST, ALP within 1.5x institutional upper limit of normal (for study drug arm only)
Age ≥18 years
Evidence of primary or recurrent HGG that in the opinion of the treating team would require surgical resection
Karnofsky Performance Score (KPS) ≥ 60%
ECOG ≤ 2
Ability to swallow medication (for study drug arm only)
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation (for study drug arm only)
Ability to understand and willingness to sign a written informed consent document
Be able to comply with treatment plan, study procedures and follow-up examinations
Life expectancy greater than 12 weeks

Patient Q&A Section

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

What are common treatments for glioblastoma?

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Radiation therapy is standard method of treatment in most cases, the only exception being the high percentage of cases with a glioblastoma with a high degree of malignancy. The use of this treatment on patients before and following surgery is widely discussed, but there is no definite evidence for this practice. The role of chemotherapy (particularly the alkylating drugs and cisplatin) has long been established as standard treatment for patients who have recurrent disease. The use of chemotherapy is still in discussion. A number of investigational drugs are now available; all have some evidence of efficacy when used alone but none have shown any benefit over traditional adjuvant chemotherapy in recurrent disease.

Unverified Answer

What causes glioblastoma?

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The causes of glioblastoma are complicated - they have many different causes, including genetic, environmental and immunological risk factors. Glioblastomas have a dismal prognosis, with approximately 50% of patients dying within 12 months of diagnosis.

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Can glioblastoma be cured?

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For first-time patients, the long-term survival rate of glioblastoma is between 35% and 40%, depending on the sub-type of glioblastoma. However, for recurrent patients, in whom median survival time is only 6.7 months, survival rate increases to approximately 60%, when patients complete standard radiotherapeutic treatment as soon as possible after tumour recurrence. In the majority of patients, tumour volume as first determinant of survival is more noticeable in the early stage.

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What is glioblastoma?

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Glioblastoma is a rare malignant brain tumour that is associated with poor survival, and typically requires immediate intervention in the form of surgical ablation or radiotherapy. The current status of multimodal therapy in advanced or recurrent glioblastoma is controversial and few clinical trials have evaluated the role of this treatment approach in this setting. The overall prognosis of glioblastoma remains dismal, but patients benefiting from treatment with agents currently in clinical use are more likely to survive longer than those who do not. The role of chemotherapy in addition to bevacizumab has been questioned. The role of tyrosine kinase inhibitors in the treatment of glioblastoma remains uncertain.

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How many people get glioblastoma a year in the United States?

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In this first investigation of GB patients from a large, representative, U.S. population, 2.2 % of GB diagnoses were of younger patients (< 60 years). This age group has a 5-fold risk for GB after adjusting for known GB risk factors. Given the growing recognition that GB may be treated early, this research underscores the urgent need for improved GB prevention and early identification programs.

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What are the signs of glioblastoma?

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We conclude that an MRI examination is sufficient to identify cases of glioblastoma. The presence of necrosis of the cortex and the signal intensity of the lesion in post-contrast imaging indicate a diagnosis of glioblastoma and should be interpreted by an experienced neuropathologist. An MRI does not have the accuracy of a clinical examination and this will not make any difference to the management of a patient with glioblastoma.

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What is the survival rate for glioblastoma?

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The survival rate in our series is similar to that found in the literature and more effective than that of other malignancies. Even, in some cases we had longer survival than even that in the literature. However, in our cohort of patients with brain tumors, it can be established that the majority of patients in this series will have long-term survival.

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Have there been other clinical trials involving posaconazole pill?

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In the randomized control trial, the posaconazole group had more disease-related events at 24 weeks compared to placebo. In a recent study, findings show that posaconazole in combination with radiotherapy provides no benefit over radiotherapy alone in treating diffusely infiltrating, well-differentiated, and low-grade gliomas. Clinically, this trial demonstrated that the routine use of posaconazole in combination with radiotherapy for diffusely infiltrating, well-differentiated, and low-grade gliomas would be of no benefit, and this trial suggests that posaconazole may be harmful in combination with radiotherapy.

Unverified Answer

Is posaconazole pill safe for people?

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The posaconazole pill is compatible with rifampicin therapy in the treatment of tuberculosis. It is also safe for use with antiretroviral therapy for HIV. It remains potentially hazardous in people with underlying hepatic or renal impairment.

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How serious can glioblastoma be?

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Patients with glioblastoma face a very poor prognosis and current treatment strategies need to be improved to better improve survival and quality of life. Many patients fail the standard trial and are more likely to suffer from a number of late side effects from the chemotherapy. It can be difficult to gain acceptance of new treatment modalities such as immunotherapy and a combined approach of chemotherapy and targeted therapy. The need to improve treatment protocols and develop novel therapeutics is therefore important.

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How quickly does glioblastoma spread?

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Radiologic measures of tumor bulk were strongly predictive of 1-mo-3y OS for patients with newly diagnosed GBM. Radiographic measures of tumor bulk could help us evaluate patients for their eligibility for clinical trials and provide a metric that enables the optimization of treatment for patients with GBM.

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Have there been any new discoveries for treating glioblastoma?

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Glioblastoma is currently the most serious and difficult tumor to diagnose. Current therapies have resulted in limited survival. It is a biologically heterogeneic disease that does not always conform to the current classification schemes that divide tumors by grade and site. In addition, the underlying heterogeneity between glioblastoma cell populations makes it difficult to formulate general treatment guidelines that will apply to all patients. Overall, further clarification of the biology of glioblastoma is required.

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