10 Participants Needed

Acetazolamide + Temozolomide for Brain Cancer

BY
Overseen ByBakhtiar Yamini, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Chicago
Must be taking: Temozolomide
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.12345

Is 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.24567

What 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.12358

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.

Research Team

BY

Bakhtiar Yamini, MD

Principal Investigator

University of Chicago

Eligibility 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.
See 1 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
See 3 more

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

Treatment Details

Interventions

  • Acetazolamide
  • Temozolomide
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Findings from Research

Temozolomide (TMZ) is shown to be more cost-effective than the traditional PCV treatment for glioblastoma multiforme (GBM), with costs of €2367 per extra life-month and €32,471 per quality-adjusted life-year (QALY).
The analysis indicates that TMZ has a high probability (over 60%) of being the most cost-effective treatment option at various willingness-to-pay thresholds, especially when considering quality of life improvements.
Economic evaluation of temozolomide in the treatment of recurrent glioblastoma multiforme.Martikainen, JA., Kivioja, A., Hallinen, T., et al.[2018]
The study confirmed that the generic temozolomide capsules (TOZ039) are bioequivalent to the brand Temodal® capsules, with pharmacokinetic parameters falling within the acceptable range for both 20-mg and 100-mg doses in 29 patients with brain tumors.
The treatment was found to be safe, with no treatment-related severe adverse events or mortality reported, although 82.8% of patients experienced some adverse effects, highlighting the importance of monitoring patient responses during treatment.
Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal®) in glioma patients in China.Hu, C., Lin, Q., Liu, C., et al.[2021]
In a randomized trial involving 447 patients with recurrent high-grade glioma, temozolomide (TMZ) did not show a clear survival advantage over procarbazine, lomustine, and vincristine (PCV), with a hazard ratio of 0.91, indicating similar effectiveness.
However, within the TMZ treatment groups, the 5-day regimen demonstrated better overall progression-free survival and quality of life compared to the 21-day regimen, suggesting that shorter treatment schedules may be more effective.
Temozolomide versus procarbazine, lomustine, and vincristine in recurrent high-grade glioma.Brada, M., Stenning, S., Gabe, R., et al.[2022]

References

Economic evaluation of temozolomide in the treatment of recurrent glioblastoma multiforme. [2018]
Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal®) in glioma patients in China. [2021]
Temozolomide versus procarbazine, lomustine, and vincristine in recurrent high-grade glioma. [2022]
Future directions for temozolomide therapy. [2019]
Phase II trial of temozolomide in patients with progressive low-grade glioma. [2022]
Temozolomide-related hematologic toxicity. [2018]
Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]
A multicenter prospective observational study of the conformity of temozolomide prescriptions in France. [2018]
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