Status:
RECRUITING
Investigating Mechanistic Predictors of Interpatient Variability and Temozolomide (TMZ) Induced Haematological Toxicity for Glioma Patients
Lead Sponsor:
University College Cork
Collaborating Sponsors:
University Hospital Waterford
Conditions:
Glioma
Eligibility:
All Genders
18+ years
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-gr...
Detailed Description
Concurrent (with radiotherapy) and adjuvant temozolomide (TMZ) is the standard of care treatment for high grade glioma, however, severe haematological toxicity is a major dose limiting factor, impacti...
Eligibility Criteria
Inclusion
- Part A
- 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.
Exclusion
- 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:
- 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).
- 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.
Key Trial Info
Start Date :
August 22 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06546631
Start Date
August 22 2024
End Date
February 1 2027
Last Update
October 2 2024
Active Locations (1)
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1
Cork University Hospital
Cork, Ireland