RecruitingPhase 1NCT05698524

A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma

A Phase I Study of Metronomic Temozolomide With Abexinostat (PCI-24781) for Patients With Recurrent High Grade Glioma


Sponsor

University of Nebraska

Enrollment

24 participants

Start Date

Jun 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Glioblastoma (GBM), WHO grade IV glioma, represents the majority of adult malignant primary brain tumors, with an incidence of 2-3 per 100,000 person-years. The survival for GBM has increased in the last decade but is still low with a median survival of 15-18 months. Recurrence after initial standard therapy, radiation therapy and chemotherapy with temozolomide, few options are available. Even with further therapy, median progression free survival at 6 months after first relapse (PFS-6) is only 15%. Similarly, anaplastic astrocytoma and anaplastic oligodendroglioma, grade III gliomas, once recurrent after radiation therapy and first-line chemotherapy, have identical therapeutic options and poor outcomes with PFS-6 of 31%. Temozolomide (TMZ) has a favorable side effect profile and is available orally, however, cytotoxicity occurs. Metronomic temozolomide at low doses on a continuous schedule, have demonstrated better survival in studies. This study will determine the recommended dose and the side effects of PCI-24781/Abexinostat with metronomic temozolomide.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of temozolomide (standard chemotherapy) and abexinostat — a drug that helps reactivate cancer-suppressing genes — in people whose high-grade brain tumor (glioma) has come back after previous treatment. **You may be eligible if...** - You are 19 or older with a biopsy-confirmed high-grade glioma (grade III or IV, such as glioblastoma) - You have previously received radiation therapy and temozolomide chemotherapy - Your tumor has progressed or it has been at least 3 months since finishing chemoradiation - You are in reasonable health (ECOG 0–2) with adequate blood counts and organ function **You may NOT be eligible if...** - You have serious heart conditions (e.g., long QT syndrome) - You are taking certain medications that interact with the study drugs - You are unable to swallow pills - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPCI 24781

Participants will take PCI-24781/Abexinostat on days 1 - 4, 8 - 11, and 15 - 18 of each 28-day cycle.

DRUGTemozolomide

Participants will receive temozolomide at a dose of 50 mg/mg2, taken by mouth once daily.


Locations(1)

University of Nebraska Medical Center

Omaha, Nebraska, United States

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NCT05698524


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