This phase I trial studies the side effects and best dose of acetazolamide sodium when given together with temozolomide in treating adult patients with newly diagnosed MGMT promoter-methylated IDH wildtype glioblastoma. Acetazolamide sodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving acetazolamide sodium and temozolomide may work better in treating adult patients with newly diagnosed glioblastoma.
Additional locations may be listed on ClinicalTrials.gov for NCT03011671.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the safety, tolerability and adverse event profile of adding acetazolamide sodium (acetazolamide) to temozolomide in patients with newly diagnosed IDH wildtype glioblastoma.
SECONDARY OBJECTIVES:
I. To describe the objective response rate (ORR), progression free survival (PFS) and overall survival (OS).
II. To determine the feasibility of the cooperative interaction between BrainUp, the University of Chicago Medical Center, NorthShore University HealthSystem, Northwestern Memorial Hospital, Northwestern Medicine Central DuPage Hospital, University of Illinois Chicago Medical Center, Rush University Medical Center, Illinois Cancer Care (Peoria) and Decatur Memorial Hospital.
III. To evaluate Bcl-3 expression level within each tumor and to preliminarily examine the ability of Bcl-3 to predict response to temozolomide (TMZ) and the efficacy of adding acetazolamide sodium (ACZ).
OUTLINE: This is a dose-escalation study of acetazolamide sodium.
CONCOMITANT PHASE: Patients receive temozolomide orally (PO) daily on days 1-42 while undergoing focal radiotherapy.
MAINTENANCE PHASE: Patients receive temozolomide PO daily on days 1-5 and acetazolamide sodium PO twice daily (BID) on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months.
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorBakhtiar Yamini