drugset / Trial / NCT03011671

Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma

NCT03011671

Phase 1 Active not recruiting 10 enrolled University of Chicago National Institutes of Health (NIH) · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase I study that examines the rate of dose limiting side effects in patients with malignant astrocytoma treated with combination acetazolamide (ACZ) and temozolomide (TMZ). Eligible patients must have histologically proven newly diagnosed, O6-methylguanine-DNA methyltransferase (MGMT) methylated WHO grade III or IV astrocytoma and be planning to undergo treatment with standard adjuvant TMZ (after completing treatment with TMZ and ionizing radiation (IR)). During this study, patients will receive daily oral ACZ with TMZ. During each cycle, ACZ will be started on the day of TMZ initiation and continued for a total of 21 days.

Timeline

Start
2018-10-03
Primary completion
2026-12
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetazolamide Small molecule 500 mg Oral
Subject Temozolomide Small molecule 150 mg/m2
Subject Temozolomide Small molecule 200 mg/m2

Indications