Acetazolamide for Glioma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Chicago Medical Center, Chicago, IL
Glioma+1 More
Acetazolamide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug combination can be safely administered to patients with malignant astrocytoma.

See full description

Eligible Conditions

  • Glioma
  • Malignant Glioma of Brain

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Acetazolamide will improve 1 primary outcome and 5 secondary outcomes in patients with Glioma. Measurement will happen over the course of 28 Days.

28 Days
Number of participants with adverse events
6 months
Measure objective response rate (ORR); change in tumor size
Time until progression free survival (PFS)
Year 6
To determine feasibility of cooperative interaction between multiple sites
Month 100
Time until overall survival (OS)
Through study completion an average of one year
Analysis of formalin fixed paraffin embedded surgical specimens.

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Acetazolamide with Temozolomide
1 of 1
Experimental Treatment

This trial requires 60 total participants across 1 different treatment group

This trial involves a single treatment. Acetazolamide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Acetazolamide with TemozolomideSubjects 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetazolamide
FDA approved
Temozolomide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion an average of one year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion an average of one year for reporting.

Closest Location

University of Chicago Medical Center - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Glioma or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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%.
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).

Patient Q&A Section

What causes glioma?

"The study of cancer genetics provides a comprehensive approach for investigating factors that may confer increased or decreased risk. For example, in this study, the association between ALK-rearranged NSCLC and age at diagnosis is consistent with the observation that patients diagnosed with cancer in their 70s carry a higher risk of being diagnosed with ALK-rearranged NSCLC after the age 65 (i.e. they are diagnosed at a higher "late stage" of the disease). Recent findings support recommendations which consider ALK status in patients with solid primary malignancies, even if not otherwise tested." - Anonymous Online Contributor

Unverified Answer

How many people get glioma a year in the United States?

"The incidence of malignant glioma is between 4% and 5% of all malignancies, although most cases are diagnosed at an earlier stage than the incidence in the United States. If cancer incidence rates were to fall in the United States, a substantial increase in the number of patients would be expected who have only low-grade and high-grade gliomas." - Anonymous Online Contributor

Unverified Answer

What are the signs of glioma?

"This information should be used to detect and differentiate a cancer. And if there is no improvement, follow up examinations and diagnostic treatments may be required to ensure that there is no recurrence. There are many clinical signs and symptoms of gliomas including headache, confusion, vomiting, and seizures. These symptoms will be indicative of the diagnosis of glioma but can also be mistaken for other conditions such as meningitis or encephalitis. The best way to differentiate between these conditions is through a complete neurological evaluation including a complete neurological exam and brain imaging using magnetic resonance imaging (MRI) or computerized tomography (CT) to detect any signs of a tumor invading the brain." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glioma?

"There is a large number of drugs used in treating gliomas, mostly targeting cell proliferation. A number of these treatments have been approved by the US FDA. Drugs that bind and activate dopamine receptors including antipsychotics, anticonvulsants and antiparkinsonian drugs can also be used as anti-glioma treatments. Recently, antiangiogenesis agents such as bevacizumab were also found to be effective in treating most gliomas. A variety of radiation therapies can also be used for glioma including external beam radiation, proton therapy, stereotactic radiosurgery and radiosurgery with drugs." - Anonymous Online Contributor

Unverified Answer

Can glioma be cured?

"The most likely explanation for this discrepancy between the findings of our study (i.e., that there is high cure rate) and that of the literature (i.e. that no cure is expected) is that ours was an older population and that there is a difference in biology between pediatric and adult glioma. However, more research is needed to confirm these findings." - Anonymous Online Contributor

Unverified Answer

What is glioma?

"Glioma is an incurable and highly malignant cancer that typically occurs in the brain and central nervous system. The average life expectancy following diagnosis of a malignant glioma is 6.4 months. Onset of signs and symptoms and duration of symptoms vary greatly with patient and tumor-related prognostic factors. The American Cancer Society estimated 12,670 patients with glioma would be diagnosed in 2006, which would result in 1,090 deaths.\n" - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for glioma?

"Although the findings from our study could suggest the usefulness of clinical trials, participation by patients may be difficult. Caregivers and families need to be informed as to the potential benefits and risks of clinical trials. Clinicians may also need to educate patients and their families to better understand the benefits and possible risks of clinical trials." - Anonymous Online Contributor

Unverified Answer

Does glioma run in families?

"There is evidence that gliomas run in families. To a certain extent, this may be attributable to genetic defects including de novo and inherited mutations that predispose to glioma development. These genetic defects may also be a cause of the occurrence of gliomas in families with a history for an inherited susceptibility." - Anonymous Online Contributor

Unverified Answer

What is acetazolamide?

"Acetazolamide increased histone acetylation in xenografted tumors and in vitro glioma cell line treated with acetazolamide at non-cytotoxic doses. The mechanism of acetazolamide's anti-glioma action is related to the ability of acetazolamide to affect multiple transcriptionally relevant targets including histone acetyltransferase HAT1, HDAC1, HDAC3 and histone deacetylases HDAC2 and HDAC8. The finding that acetazolamide inhibited HDAC2 through a non-classical mechanism suggests that non-physiological agents may have therapeutic benefit in treating glioma." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of glioma?

"This is a most difficult question and we have to look at all the things which must be considered. Although our findings are not complete and definite, they do provide insights into the pathogenesis of both adult and pediatric gliomas. It is very important that we continue to investigate all of the known causes of gliomas. We must have a better understanding of the role of the genetic and physical factors. This must include the role of UV light, carcinogens, chemotoxins, infectious agents and other environmental factors which may modify the development of these tumors. It is important that we gain a better understanding of the role all these substances have over the course of time." - Anonymous Online Contributor

Unverified Answer

How quickly does glioma spread?

"Rapid progress of glioma to the central nervous system and brain with a high incidence of malignant transformation to glioblastoma are in a continuous chain. Even though patients show no symptoms in early stages of glioma progression, the disease might be at an alarming stage when the patient becomes symptomatic." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating glioma?

"According to these results, a combination of adjuvant treatment with temozolomide and external radiation is superior to adjuvant treatment with RT plus other drugs. However, there are several new treatments that are not yet widely used. As well as having a very favorable profile in patients' treatment, these treatments work in two or even three ways. Combination therapy is better than single treatment. The combination of alkylating drugs and radiation achieves a higher efficacy, and it is safer to use. Targeting the notch signaling pathway could be a new therapeutic option in combination with alkylating agents for patients with glioma." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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