Daily Temozolomide for Elderly Patients With Unmethylated MGMT- Promoter Newly Diagnosed GliOblatoma (TEMPO)

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.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma
• Intervention / Treatment: Drug: Daily TMZ

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Delareese Mackenzie; Phone Number: 67862 4164806100; Email: delareese.mackenzie@sunnybrook.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Daily TMZ	Drug: Daily TMZ; Following completion of radiation therapy, temozolomide will be administered daily for 5 days each of a 28-day cycle, for a maximum of 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	How long the participant survives following initial diagnosis	From initial diagnosis until date of death from any cause (assessed up to 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	From initial diagnosis until disease progression	From initial diagnosis until disease progression (assessed up to 24 months)
Toxicities	The side effects that participants experience while on study treatment	From treatment start through study completion (estimated up to 5 years)

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: TEMPO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No