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

NCT06546631 | Recruiting

• 1 other identifier: 24010
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (2)

• Determine potential predisposing factors for severe haematological toxicity from temozolamide

  Analysis of pharmacogenes

  On study registration

• Determine potential predisposing factors for severe haematological toxicity from temozolamide

  Microbiome analysis of stool bacterial composition

  Baseline and study completion, an average of 9 months

Secondary Outcomes (8)

• Assess duration of haematological toxicity from temozolamide

  Up to 12 months

• Assess severity of haematological toxicity from temozolamide

  Up to 12 months

• Assess the impact of haematological toxicity on patients

  Up to 12 months

• Assess the impact of haematological toxicity on patients

  Up to 12 months

• Assess the impact of toxicity on patients distress tool scores

  On date of study registration

Study Arms (2)

Temozolamide treatment

Patients who are being started on Temozolamide treatment for high-grade glioma. Patients will provide blood, saliva and stool samples.

Temozolamide toxicity

Patients who have developed dose-limiting haematological toxicity during treatment with TMZ for a high grade glioma. Patients will provide blood, saliva and stool samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients under the care of a medical oncologist attending a hospital clinic for the treatment of their high grade glioma

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).
• 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.
• 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.

Sponsors & Collaborators

• University College Cork: lead
• University Hospital Waterford: collaborator

Study Sites (1)

Cork University Hospital

Cork, Ireland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool, saliva and blood samples.

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Jack Gleeson

CONTACT

0214922603; jgleeson@ucc.ie

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 9, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

IE (1)