Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03011671
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2017-01-04
Brief Title:
Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase I Study of Safety and Tolerability of Acetazolamide With Temozolomide in Adults With Newly Diagnosed MGMT Promoter-Methylated IDH Wildtype Glioblastoma
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None