Actively Recruiting
Daily Temozolomide for Elderly Patients With Unmethylated MGMT- Promoter Newly Diagnosed GliOblatoma
Led by Sunnybrook Health Sciences Centre · Updated on 2026-03-17
118
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Glioblastoma is an aggressive type of brain cancer. Standard treatment usually includes three weeks of radiation therapy alone or combined with chemotherapy using Temozolomide. After a four- to six-week break, more Temozolomide chemotherapy is usually given. However, some tumors have a marker ("unmethylated MGMT") that predicts the usual chemotherapy won't work. Because of this, this project will explore other treatment options to help slow the disease and improve survival. In this study, the same chemotherapy (Temozolomide) normally given after radiation therapy for glioblastoma. The only difference is that it will be given with a modified regimen.
CONDITIONS
Official Title
Daily Temozolomide for Elderly Patients With Unmethylated MGMT- Promoter Newly Diagnosed GliOblatoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Newly diagnosed WHO grade 4 IDH wild-type glioblastoma confirmed by tissue analysis
- Tumor has unmethylated MGMT promoter based on local testing
- Completed radiation therapy of 40 Gy in 15 fractions with concurrent Temozolomide within 6 weeks before enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Karnofsky Performance Status (KPS) of 60 or higher
- Adequate organ function shown by lab test results within 28 days before enrollment including:
- Absolute neutrophil count over 1,500 cells/mm³
- Platelet count over 100,000 cells/mm³
- Serum creatinine less than 1.5 times the upper normal limit
- Total serum bilirubin less than 1.5 times the upper normal limit
- ALT and/or AST less than 2.5 times the upper normal limit
- Signed informed consent obtained from participant or legal representative
You will not qualify if you...
- Presence of diffuse leptomeningeal involvement at diagnosis
- Unable to have contrast-enhanced MRI
- Known allergy to Temozolomide or Dacarbazine
- Severe myelosuppression
- Active hepatitis B infection
- Severe or uncontrolled medical conditions that may affect safety or study completion, including active systemic infection, diabetes, hypertension, coronary artery disease, or psychiatric disorders
- History of prior or second invasive cancer except:
- Non-melanoma skin cancer
- Completely removed cervical carcinoma in situ
- Low risk prostate cancer or under active surveillance
- Other cancers treated with curative intent more than 3 years before study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here