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

  • STATUS
    Recruiting
  • End date
    Mar 22, 2022
  • participants needed
    60
  • sponsor
    University of Chicago
Updated on 22 June 2021

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.

Details
Condition Malignant Glioma of Brain
Treatment Temozolomide, acetazolamide
Clinical Study IdentifierNCT03011671
SponsorUniversity of Chicago
Last Modified on22 June 2021

Eligibility

Yes No Not Sure

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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