Neuro-pharmacological Properties of Repurposed Posaconazole in Glioblastoma: A Phase 0 Clinical T… (NCT04825275) | Clinical Trial Compass
TerminatedEarly Phase 1
Neuro-pharmacological Properties of Repurposed Posaconazole in Glioblastoma: A Phase 0 Clinical Trial
Stopped: The study was stopped due to slow accrual.
United States7 participantsStarted 2022-05-13
Plain-language summary
This research is being done to find out if the study drug (posaconazole) can enter brain tumors at a high enough amount to stop the tumor cells from dividing. Posaconazole is a drug which doctors already use for fungal infections and is thought to be able to effect tumor cells. As treatments for this type of brain tumor are limited, it is hoped that the results of this study will help to determine if the study drug should be studied further as a possible treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
* Life expectancy greater than 12 weeks
* Adequate liver function defined as ALT, AST, ALP within 1.5x institutional upper limit of normal (for study drug arm only)
* 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
Exclusion Criteria:
* Patients may not be receiving any other investigational agents while on study
* Patients who have known allergy to posaconazole or other azoles (for study drug arm only)
* 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 (for study drug arm only)
* Patients with a history of acute or chronic hepatitis (for study drug arm only)
* Patients with liver enzymes (ALT, AST, ALP) \>1.5x above normal range for the laboratory performing the test (for study drug arm only)
* Patients who are taking metronidazole and cannot be safely moved to a different antib…
What they're measuring
1
Posaconazole Concentration in Cerebrospinal Fluid Using Microdialysis Catheters
Timeframe: Collected over a 24-hour period after surgery (biopsy or resection)