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RecruitingNCT07476794TEMPOUpdated Mar 17, 2026

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

A Phase 2 interventional study of Daily TMZ in Glioblastoma, sponsored by Sunnybrook Health Sciences Centre. Recruiting at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by Sunnybrook Health Sciences Centre · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
118
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Glioblastoma

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03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's planned enrollment of 118 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
118 participants (estimated)

Study arms

  • Experimental
    Treatment

    Daily TMZ

    Drug: Daily TMZ

Interventions

  • DrugDaily 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

06

What researchers measure

Primary outcomes

  1. Overall survival

    How long the participant survives following initial diagnosis

    Time frame: From initial diagnosis until date of death from any cause (assessed up to 24 months)

Secondary outcomes

  1. Progression-free survival

    From initial diagnosis until disease progression

    Time frame: From initial diagnosis until disease progression (assessed up to 24 months)

  2. Toxicities

    The side effects that participants experience while on study treatment

    Time frame: From treatment start through study completion (estimated up to 5 years)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07476794
Lead sponsor
Sunnybrook Health Sciences Centre
Responsible party
Sponsor
First posted
Mar 17, 2026
Start date
Nov 1, 2025
Primary completion
Oct 2027 (estimated)
Completion
Nov 2029 (estimated)
Last update
Mar 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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