Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Gl… (NCT03011671) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma
United States10 participantsStarted 2018-10-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily designed to measure adverse events and safety, what does that mean for what we actually know so far about whether this combination of acetazolamide and temozolomide helps treat my glioma?
2The trial is listed as 'active, not recruiting' — does that mean enrollment is closed, and if so, are there any similar trials combining acetazolamide with chemotherapy that I might still be eligible for?
3Temozolomide is already a standard chemotherapy for malignant glioma — could I receive temozolomide on its own through standard care first, and would that affect my options for joining a trial like this in the future?
4Acetazolamide is typically used as a diuretic and for altitude sickness, so what specific side effects or interactions should I watch for if this drug is combined with chemotherapy for a brain tumor?
5Given that I have a newly diagnosed glioma versus a recurrent one, does my specific situation change how my doctor would weigh the risks and potential benefits of joining a Phase 1 study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.