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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cork University Hospital
  Cork, Ireland Recruiting

Study contacts

• Study coordinator: Jack Gleeson
• Email: jgleeson@ucc.ie
• Phone: 0214922603

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• YN003 injection in glioma patients

  This phase 1 study tests whether YN003 injected IV is safe and tolerable for adults with recurrent or progressive glioma, and to explore how the drug behaves in the body and any early signs of activity.

  Recruiting at 2 sites Phase 1 Beijing Inno Medicine Co., Ltd. · Los Angeles, California and 4 other locations · NCT07929909

• Brain connectome project in adults with brain glioma undergoing surgery

  This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.

  Recruiting Northwell Health · New York, New York · NCT07927595

• Proton vs. Photon Radiation for Certain Grade 2–3 Gliomas

  This study tests whether proton therapy can better preserve thinking and memory than photon therapy for adults with IDH-mutated grade 2–3 gliomas who need radiation.

  Recruiting at 2 sites University Hospital, Essen · Essen and 1 other locations · NCT07750457

• Connectome-guided network planning for brain tumor surgery in eloquent areas

  This study tests whether using patient-specific brain network maps from diffusion MRI can help surgeons plan and guide brain tumor removal in eloquent areas.

  Recruiting ARNAS Civico Di Cristina Benfratelli Hospital · Palermo, PA · NCT07717827

• AI-powered analysis of brain MRI to help glioma care

  Doctors will use AI to study existing MRI scans and patient data from adults with glioma to see if it can help with non-invasive diagnosis and treatment planning.

  Recruiting Università degli Studi di Trento · Trento · NCT07703761

• Safusidenib in IDH1-mutant glioma after vorasidenib progression

  This trial tests safusidenib in people with IDH1-mutant glioma who progressed on vorasidenib and did not need immediate chemo or radiation.

  Recruiting at 2 sites Phase 2 Nuvation Bio Inc. · Los Angeles, California and 11 other locations · NCT07703436

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.