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NCT03011671 · ClinicalTrials.gov registry record · Phase 1
Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma
A Phase 1 study of Malignant Glioma of Brain, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03011671: Completed Phase 1 study of Malignant Glioma of Brain, sponsored by University of Chicago.
NCT03011671 is a Phase 1 study of Malignant Glioma of Brain that has completed, run by University of Chicago. The registered enrollment target is 10 participants, below the 33-participant average among 3 other Malignant Glioma of Brain trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03011671, a Phase 1 study of Malignant Glioma of Brain, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To determine the safety, tolerability and adverse event profile of adding acetazolamide to temozolomide in patients with newly diagnosed malignant astrocytoma.
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Acetazolamide
Study Locations (1)
Illinois
- University of Chicago Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-10-03 |
| Est. Completion | 2025-03-14 |
| Phase | Phase 1 |
What the finished NCT03011671 record still lists
NCT03011671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 33-participant average among 3 other Malignant Glioma of Brain trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Malignant Glioma of Brain appearing as the primary indexed condition, and to 2 interventions - of which Temozolomide is the first listed.
NCT03011671 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03011671 about?
NCT03011671 is a clinical study titled "Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma". 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) me...
What is the current status of trial NCT03011671?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2018-10-03. Estimated completion is 2025-03-14.
What conditions does trial NCT03011671 study?
This clinical trial studies the following conditions: Malignant Glioma of Brain.
What interventions are being tested in trial NCT03011671?
The interventions under investigation include: Temozolomide (DRUG), Acetazolamide (DRUG).
Who is sponsoring clinical trial NCT03011671?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03011671 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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