A medication called temozolomide has been used for many years in the treatment of high-grade gliomas, which are tumours that originate in the brain. While this drug is the normal treatment for high-grade glioma, a number of patients develop a side-effect which results in low levels of some important blood cells, such as platelets or white blood cells. If this side-effect occurs, treatment with temozolomide may have to be stopped or paused, which may affect how well this treatment works.
At present, it is unknown why some patients develop this side effect and others do not. It is known that patients with a higher concentration of temozolomide in their blood are at an increased risk of developing this toxicity. There may be some factors associated with the movement of the drug in the body or the removal of the drug from the body which may affect the concentration of temozolomide in blood. There are many factors which may be involved, including genes, other medicines that are taken, how well kidneys and liver are working or even the microbiome (which is the bacteria in the gut).
This study is being done to find out what these factors could be. In the future, this may lead to medical care teams being able to predict which patients are at higher risk of side-effects, allowing them to implement measures to reduce the risk of this occurring.
18 years of age or over
Will receive or are currently receiving concurrent phase treatment with TMZ for high grade glioma (WHO Grade 3 or Grade 4 Astrocytoma, Oligodendroglioma or Glioblastoma).
Provision of informed consent to participate.
18 years of age or over
Receiving or received treatment with TMZ for high grade glioma (WHO Grade 3 or Grade 4 Astrocytoma, Oligodendroglioma or Glioblastoma).
Patients under the care of a medical oncologist attending a hospital clinic for the treatment of their high grade glioma
Case-only
Prospective
Not listed
Determine potential predisposing factors for severe haematological toxicity from temozolamide
Analysis of pharmacogenes
Determine potential predisposing factors for severe haematological toxicity from temozolamide
Microbiome analysis of stool bacterial composition
Assess duration of haematological toxicity from temozolamide
Duration measured in time (days/weeks).
Assess severity of haematological toxicity from temozolamide
Severity measured by Common Terminology Criteria for Adverse Events (CTCAE) Grade (grades range from 1-5, with higher grades indicating higher severity).
Assess the impact of haematological toxicity on patients
Number of blood transfusions required as a result of the haematological toxicity
Assess the impact of haematological toxicity on patients
Number of platelet transfusions required as a result of the haematological toxicity
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University College Cork
Lead sponsor
University Hospital Waterford
Collaborator
