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Alkylating Agent

Acetazolamide + Temozolomide for Brain Cancer

Phase 1

Recruiting

Led By Bakhtiar Yamini, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with prior low grade astrocytoma and subsequent histological evidence of grade III or IV tumor

Histologically proven, newly diagnosed IDH wildtype glioblastoma (GBM) with a methylated MGMT promoter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study enrollment period (approximately 6 years)

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to see if it is safe and has fewer side effects than other treatments.

Who is the study for?

Adults with a specific type of brain tumor called malignant astrocytoma, who have not yet started or are undergoing standard treatment with Temozolomide after radiation. They must be in good enough health to participate, able to understand and sign consent, and women must not be pregnant.Check my eligibility

What is being tested?

This study tests the combination of Acetazolamide (ACZ) with Temozolomide (TMZ) for treating malignant astrocytoma. It aims to find out what doses are safe without causing too many side effects. Patients will take ACZ daily alongside their regular TMZ treatment for cycles lasting 21 days.See study design

What are the potential side effects?

Possible side effects include those related to Acetazolamide such as allergic reactions if sensitive to sulfa drugs, blood disorders from both medications, and general symptoms like fatigue or digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My low grade brain tumor has progressed to a more aggressive form.

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My glioblastoma is IDH wildtype with a methylated MGMT promoter.

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I am currently on a standard treatment plan that includes TMZ after having TMZ and radiation.

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I can care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion an average of one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion an average of one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion an average of one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events

Secondary outcome measures

Analysis of formalin fixed paraffin embedded surgical specimens.

Measure objective response rate (ORR); change in tumor size

Time until overall survival (OS)

+2 more

Side effects data

From 2022 Phase 4 trial • 11 Patients • NCT03377049

External Ventricular Drainage infection

Hydrocephalus

Pulmonary edema

Cardiomyopathy

100%

80%

60%

40%

20%

Study treatment Arm

Acetazolamide Challenge

Trial Design

1Treatment groups

Experimental Treatment

Group I: Acetazolamide with TemozolomideExperimental Treatment2 Interventions

Subjects will receive daily ACZ together with TMZ in 28 day cycles for up to 6 cycles if they do not experience either disease worsening or unacceptable side effects.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetazolamide

2011

Completed Phase 4

~2910

Temozolomide

2010

Completed Phase 3

~1930