GlioblastomaPhase 2TEMPONCT07476794
Daily Temozolomide for Elderly Patients With Unmethylated MGMT- Promoter Newly Diagnosed GliOblatoma
A Phase 2 study testing Daily TMZ in people with Glioblastoma, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Daily TMZ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2025to Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Delareese Mackenzie, 4164806100 ext. 67862, delareese.mackenzie@sunnybrook.ca
About this study
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
- Glioblastoma
- Being tested
- Daily TMZ
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily TMZDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Daily TMZ Receives: Drug: Daily TMZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
How long the participant survives following initial diagnosis
Measured: From initial diagnosis until date of death from any cause (assessed up to 24 months)
Secondary outcomes (2)
Progression-free survival
From initial diagnosis until disease progression
Measured: From initial diagnosis until disease progression (assessed up to 24 months)
Toxicities
The side effects that participants experience while on study treatment
Measured: From treatment start through study completion (estimated up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Nov 2025
- Primary completionOct 2027 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476794
- Sponsor's protocol ID
- TEMPO
- Acronym
- TEMPO
- Status last verified
- Nov 2025
- First submitted
- 20 Jan 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Temozolomide for Elderly Patients With Unmethylated MGMT- Promoter Newly Diagnosed GliOblatoma
- ClinicalTrials.gov ID
- NCT07476794
- Acronym / sponsor ID
- TEMPO / TEMPO
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Daily TMZDaily TMZ |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily TMZFollowing completion of radiation therapy, temozolomide will be administered daily for 5 days each of a 28-day cycle, for a maximum of 6 cycles | Drug | Treatment |
Primary outcome
Overall survival
Time frame: From initial diagnosis until date of death from any cause (assessed up to 24 months)
How long the participant survives following initial diagnosis
2 secondary outcomes
Progression-free survival
Time frame: From initial diagnosis until disease progression (assessed up to 24 months)
Toxicities
Time frame: From treatment start through study completion (estimated up to 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
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Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
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RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
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PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sunnybrook Health Sciences Centre
Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daily TMZ in people with Glioblastoma, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From initial diagnosis until date of death from any cause (assessed up to 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.