Acetazolamide + Temozolomide for Brain Cancer
Recruiting in Palo Alto (17 mi)
Overseen byBakhtiar Yamini, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Chicago
Must be taking: Temozolomide
Must not be taking: Corticosteroids
Disqualifiers: Invasive malignancy, Infection, Pregnancy, others
Stay on Your Current Meds
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a combination of two drugs, acetazolamide and temozolomide, in patients with a severe type of brain tumor. The goal is to see if this combination can improve treatment outcomes by attacking cancer cells and reducing brain pressure. Temozolomide is a drug with a good safety profile and has been effective in treating this type of brain tumor.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroid therapy, you must not exceed 8 mg of dexamethasone daily at the time of enrollment.
What data supports the effectiveness of the drug combination Acetazolamide and Temozolomide for brain cancer?
Temozolomide has shown effectiveness in treating various types of brain tumors, including glioblastoma multiforme and anaplastic astrocytoma, and is being studied for other brain cancers. It is often preferred due to its oral administration and lower side effects compared to other treatments.
12345Is the combination of Acetazolamide and Temozolomide safe for treating brain cancer?
Temozolomide is generally well tolerated and safe, with common side effects like fatigue, nausea, and low blood cell counts. However, rare but serious blood-related side effects, such as aplastic anemia, have been reported. There is no specific safety data available for the combination with Acetazolamide.
24567What makes the drug combination of Acetazolamide and Temozolomide unique for brain cancer treatment?
The combination of Acetazolamide and Temozolomide is unique because Temozolomide is an oral drug that has replaced older chemotherapy regimens due to its easier administration and better side effect profile, while Acetazolamide may enhance its effectiveness by altering the tumor environment, although this specific combination is not yet standard for brain cancer.
12358Eligibility Criteria
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.Inclusion Criteria
My low grade brain tumor has progressed to a more aggressive form.
My glioblastoma is IDH wildtype with a methylated MGMT promoter.
I am currently on a standard treatment plan that includes TMZ after having TMZ and radiation.
+2 more
Exclusion Criteria
I am currently being treated for an active infection, including HIV or toxoplasmosis.
Pregnancy confirmed by positive serum beta-hCG laboratory test, Breast-feeding
Hypersensitivity to acetazolamide or sulfonamides
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive daily oral acetazolamide with temozolomide in 28-day cycles for up to 6 cycles
6 months
Monthly visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Extension
Participants may continue treatment if they do not experience disease worsening or unacceptable side effects
Long-term
Participant Groups
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.
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.
Temozolomide is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Temodal for:
- Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment
- Children from the age of three years, adolescents and adults with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy
🇺🇸 Approved in United States as Temodar for:
- Newly diagnosed glioblastoma concomitantly with radiotherapy and subsequently as monotherapy treatment
- Newly diagnosed or refractory anaplastic astrocytoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Chicago Medical CenterChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
Economic evaluation of temozolomide in the treatment of recurrent glioblastoma multiforme. [2018]Temozolomide (TMZ) is an oral alkylating agent with demonstrated efficacy as therapy for glioblastoma multiforme (GBM) and anaplastic astrocytoma. TMZ has widely replaced the procarbazine, lomustine plus vincristine (PCV) combination for the treatment of malignant brain tumours as a result of its oral administration and favourable toxicity profile.
Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal®) in glioma patients in China. [2021]Label="BACKGROUND">Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20-100 mg) of generic temozolomide in the form of TOZ039 and Temodal® capsules administered to brain tumor patients.
Temozolomide versus procarbazine, lomustine, and vincristine in recurrent high-grade glioma. [2022]Temozolomide (TMZ) is an alkylating agent licensed for treatment of high-grade glioma (HGG). No prospective comparison with nitrosourea-based chemotherapy exists. We report, to our knowledge, the first randomized trial of procarbazine, lomustine, and vincristine (PCV) versus TMZ in chemotherapy-naive patients with recurrent HGG.
Future directions for temozolomide therapy. [2019]Although the initial indications of temozolomide (Temodar in the United States, Temodal globally; Schering Corporation, Kenilworth, NJ) therapy are for refractory central nervous system malignancies (anaplastic astrocytoma in the United States and Europe, glioblastoma multiforme in Europe), a number of clinical trials are planned or ongoing to evaluate the efficacy and safety of temozolomide in newly diagnosed glioma, oligodendroglioma, pediatric glioma, brain metastases, metastatic melanoma, and other systemic tumors. Also under investigation are modifications to the temozolomide dosing schedule, other routes of administration, and treatment regimens that include temozolomide in combination with other chemotherapeutic and biologic agents. Temozolomide has the potential to be a useful agent in the treatment of a variety of cancers.
Phase II trial of temozolomide in patients with progressive low-grade glioma. [2022]Temozolomide (Temodar; Schering-Plough Corp, Kenilworth, NJ) is an imidazole tetrazinone that undergoes chemical conversion to the active methylating agent 5-(3-methyltriazen-1yl)imidazole-4-carboximide under physiologic conditions. Previous studies have confirmed activity of Temodar in the treatment of progressive and newly diagnosed malignant gliomas. We have extended these results, and now we report results of a phase II trial of Temodar for patients with progressive, low-grade glioma.
Temozolomide-related hematologic toxicity. [2018]Temozolomide (TMZ) is an oral alkylating agent used for the treatment of recurrent or newly diagnosed malignant gliomas with significant survival benefit. TMZ is generally well tolerated and safe. The most common side effects are mild to moderate, and are represented by fatigue, nausea, vomiting, thrombocytopenia, and neutropenia. However severe hematologic adverse events (HAEs), including myelodysplastic syndrome and aplastic anemia, have also been reported. In this review we present an overview of the available literature of HAEs after exposure to TMZ.
Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]Temozolomide (TMZ) is an oral alkylating agent principally indicated for neurological malignancies including glioblastoma (GBM) and astrocytoma. Most common side effects are mild to moderate, and include fatigue, nausea, vomiting, thrombocytopenia and neutropenia. Severe or prolonged myelosuppression, causing delayed treatment or discontinuation, is uncommon. Major haematological adverse effects such as myelodysplastic syndrome or aplastic anaemia (AA) have rarely been reported.
A multicenter prospective observational study of the conformity of temozolomide prescriptions in France. [2018]Temozolomide (TMZ) is approved for the treatment of high-grade gliomas such as glioblastoma (GBM) multiforme and refractory anaplastic astrocytoma, but it is also used in indications not mentioned in the summary of product characteristics (SPC). The main objective of this study was to evaluate the conformity of TMZ prescriptions to the French SPC and prescription guidebook.