New drug duo aims to improve brain cancer treatment
NCT ID NCT03011671
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether adding a drug called acetazolamide to standard chemotherapy (temozolomide) is safe for people with a newly diagnosed, aggressive brain cancer (glioblastoma). Ten adults will take both drugs daily for 21-day cycles. The main goal is to find any serious side effects and see if the combination helps control the tumor.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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10 people
The number who actually took part.
- Started
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Oct 2018
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically proven, newly diagnosed IDH wildtype glioblastoma (GBM) that has a methylated MGMT promoter as assessed by the standardized institutional analysis. * Patients are eligible if they had a prior low grade astrocytoma and there is subsequent histological evidence of a diagnosis of grade III or IV tumor. * 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). * Women able to become pregnant must have a negative pregnancy test within 30 days of registration. * Patients must have the ability to understand and the willingness to sign a written informed consent document. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Chicago Medical Center
Chicago, Illinois, 60637, United States
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Other studies related to the condition(s) this trial covers.
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