Daily temozolomide for older adults with newly diagnosed glioblastoma and unmethylated MGMT promoter

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 Phase 2 interventional trial gives a modified daily temozolomide regimen to patients aged 65 or older who have newly diagnosed WHO grade 4, IDH wild-type glioblastoma with an unmethylated MGMT promoter. Participants must have completed 40 Gy in 15 fractions with concurrent temozolomide within six weeks before enrollment. The study monitors safety, tolerability, clinical status, laboratory tests, and brain imaging while patients receive the daily dosing schedule. Key outcomes include treatment-related adverse events, progression-free survival, and overall survival.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥65 years.
* Histopathologically confirmed newly diagnosed WHO grade 4, IDH wild-type GBM
* Unmethylated MGMT promoter, according to local assessment
* Completed treatment with 40 Gy in 15 fractions over three weeks, with concurrent TMZ, within six weeks prior to enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status scale of 0, 1, or 2.
* Karnofsky Performance Status (KPS) ≥60.
* Adequate organ function, as defined by the following laboratory values obtained within 28 days prior to enrollment:

  * Absolute neutrophil count (ANC) \>1.5 × 10⁹/L (1,500 cells/mm³).
  * Platelet count \>100 × 10⁹/L (100,000 cells/mm³).
  * Serum creatinine \<1.5 times the upper limit of normal.
  * Total serum bilirubin \<1.5 times the upper limit of normal.
  * ALT (SGPT) \<2.5 times the upper limit of normal and/or AST (SGOT) \<2.5 times the upper limit of normal.
* Signed informed consent (and assent, if applicable) must be obtained from the participant or their legal representative, ensuring the participant's ability to adhere to the study requirements.

Exclusion Criteria:

* Diffuse leptomeningeal involvement at the time of diagnosis.
* Inability to undergo contrast-enhanced magnetic resonance imaging (MRI)
* Known hypersensitivity to TMZ components or Dacarbazine
* Severe myelosuppression
* Active hepatitis B infection
* Severe or uncontrolled medical conditions (e.g., active systemic infection, diabetes, hypertension, coronary artery disease, or psychiatric disorders) that, in the investigator's judgment, could compromise patient safety or impede study completion.
* History of prior or second invasive malignancy, except for:

  * Non-melanoma skin cancer.
  * Completely resected cervical carcinoma in situ.
  * Low risk prostate cancer or under active surveillance.
  * Other cancers for which the subject has completed potentially curative treatment more than 3 years prior to study entry are allowed.

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

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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.