drugset / Trial / NCT03011671
Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetazolamide | Small molecule | 500 mg | Oral |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | — |
| Subject | Temozolomide | Small molecule | 200 mg/m2 | — |