Investigating factors affecting blood cell toxicity in glioma patients treated with temozolomide

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

This study is trying to find out why some glioma patients have serious blood cell problems when treated with the chemotherapy drug temozolomide, so that treatments can be safer and more effective.

Quick facts

• Study type: Observational
• Enrollment: 55 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University College Cork (other)
• Locations: 1 site (Cork)
• Trial ID: NCT06546631 on ClinicalTrials.gov

What this trial studies

This study examines why some glioma patients experience severe blood cell toxicity when treated with temozolomide, a common chemotherapy drug. It aims to identify mechanistic predictors of this toxicity by analyzing genetic factors, renal function, and other patient characteristics. The research involves developing a pharmacokinetic model to assess how these factors influence temozolomide concentration in the blood. By understanding these predictors, the study seeks to improve treatment safety and efficacy for glioma patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and over who are currently receiving or will receive temozolomide for high-grade glioma.

Not a fit: Patients who are too unwell to provide informed consent or for whom additional blood samples are not appropriate may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized treatment plans that minimize the risk of severe side effects from temozolomide in glioma patients.

How similar studies have performed: While the approach of investigating genetic and other factors influencing drug toxicity is not entirely novel, the specific focus on temozolomide-induced hematological toxicity in glioma patients is relatively underexplored.

Eligibility criteria

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 ≥3 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 ≥3 consecutive days during concurrent phase due to FBC concerns v. Deferral of subsequently due TMZ cycle by ≥7 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.

Where this trial is running

Cork

• Cork University Hospital — Cork, Ireland (RECRUITING)

Study contacts

• Study coordinator: Jack Gleeson

Conditions: Glioma