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Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase I Study of Safety and Tolerability of Acetazolamide With Temozolomide in Adults With Newly Diagnosed MGMT Promoter-Methylated IDH Wildtype Glioblastoma

NCT03011671•University of Chicago

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically proven, newly diagnosed IDH wildtype glioblastoma (GBM) that has a methylated MGMT promoter as assessed by the standardized institutional analysis.
•Patients must be receiving TMZ as part of their standard adjuvant treatment regimen following treatment with TMZ and Radiation.
•Patients must have a Karnofsky performance ≥ 60%.
•Normal organ function as follows:
•* Absolute Neutrophil Count (ANC) ≥ 1.0 x 10\^9/ L
•* Platelets ≥ 100 x 10\^9 / L
•* Hemoglobin ≥ 8.0 g / dL
•Age 18 years or older.
•Kidney function (creatinine level within normal institutional limit, or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine level above institutional normal).
•Liver function (AST/ALT \<2.5 X institutional upper limit of normal (ULN), Total bilirubin ≤ 1.5 times ULN, INR within 1.5 times ULN (or if receiving anticoagulant therapy an INR of ≤ 3.0 is allowed with concomitant increase in PT or an aPTT ≤ 2.5 × control).
+2 more criteria

Exclusion Criteria

•Prior invasive malignancy that is not low-grade glioma (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease free and off therapy for that disease for a minimum of 3 years.
•Active systemic infection requiring treatment, including any HIV infection or toxoplasmosis.
•Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
•Systemic corticosteroid therapy, \>8 mg of dexamethasone daily (or equivalent) at study enrollment.
•Pregnant women are excluded from this study, where pregnancy is confirmed by a positive serum beta-hCG laboratory test. Breast-feeding should be discontinued.
•Hypersensitivity to acetazolamide or sulfonamides.

Locations (1)

University of Chicago Medical Center

Chicago, Illinois, United States

Key Dates

Start Date

October 3, 2018

Primary Completion Date

March 14, 2025

Completion Date

March 14, 2025

Last Updated

April 30, 2025

Enrollment

ACTUAL participants

Conditions

Malignant Glioma of Brain

Interventions

Acetazolamide

DRUG

Temozolomide

DRUG

Pilot Immunotherapy Trial for Recurrent Malignant Gliomas

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WITHDRAWN

LITT Palliative Treatment for Patients With Malignant Gliomas

NCT03176160

Malignant Glioma of BrainGlioblastoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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