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Investigating Mechanistic Predictors of Interpatient Variability and Temozolomide (TMZ) Induced Haematological Toxicity for Glioma Patients

Recruitingn/aAges 18 Years - anyAllUniversity College Cork
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Part A Inclusion Criteria: 1. 18 years of age or over 2. 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). 3. Provision of informed consent to participate. Exclusion Criteria: a. Patients who, in opinion of supervising clinician, are clinically too unwell to provide informed consent or for whom additional blood samples, or other research samples, would not be indicated or appropriate. Part B Inclusion Criteria: 1. 18 years of age or over 2. Receiving or received treatment with TMZ for high grade glioma (WHO Grade 3 or Grade 4 Astrocytoma, Oligodendroglioma or Glioblastoma). 3. Developed any CTCAE Grade โ‰ฅ3 Haematological Toxicity associated with Temozolomide, and/or any 1 of: i. Platelet count \<100 x 109/L ii. Neutrophil Count \<1.0 x 109/L iii. Haemoglobin value \<8.0 g/L iv. Omission of daily TMZ dose for โ‰ฅ3 consecutive days during concurrent phase due to FBC concerns v. Deferral of subsequently due TMZ cycle by โ‰ฅ7 days during adjuvant phase; vi. Dose reduction or permanent discontinuation of TMZ for reasons of haematological toxicity (as per treating physician discretion); vii. Use of growth factors, platelets or packed-cell transfusions during the course of TMZ. d. Provision of informed consent to participate. Exclusion criteria: a. Patients who, in opinion of supervising clinician, are clinically too unwell to provide informed consent or for whom additional blood samples, or other research samples, would not be indicated or appropriate.
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What it tests

  • Not listed
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Where

1 site
Cork University Hospital
Cork, Ireland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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