118 Participants NeededMy employer runs this trial

Daily Temozolomide for Glioblastoma

(TEMPO Trial)

Age: 65+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sunnybrook Health Sciences Centre
Must be taking: Temozolomide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of administering Temozolomide, a chemotherapy drug, for treating glioblastoma, a fast-growing brain cancer. The researchers aim to determine if altering the drug's timing benefits patients when the usual treatment is unlikely to be effective due to a specific tumor marker. Suitable participants have recently diagnosed glioblastoma, have completed a round of radiation and chemotherapy, and have a tumor with an "unmethylated MGMT" marker, indicating that standard chemotherapy might not be effective. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants, offering a chance to benefit from innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

A previous study found that temozolomide, a common treatment for glioblastoma, is generally safe, though it can cause some side effects, often affecting blood health. Despite this, many patients tolerate the drug well. Another study showed that using temozolomide for longer periods does not significantly increase survival, but the side effects remained manageable. Different research noted that the most serious outcomes included hospitalization and severe side effects, which are common with cancer treatments. Overall, the safety of temozolomide is well-understood and acceptable, especially given its long history of use in treating glioblastoma.12345

Why do researchers think this study treatment might be promising for glioblastoma?

Temozolomide is unique because it is being tested for daily use in treating glioblastoma, a brain cancer that currently uses this drug in combination with radiation in cycles. This approach could potentially enhance its effectiveness by maintaining consistent drug levels in the body, thereby providing continuous pressure on cancer cells. Researchers are excited about this treatment because it offers a novel dosing strategy that might improve patient outcomes compared to the intermittent dosing schedules typically used today.

What evidence suggests that this treatment might be an effective treatment for glioblastoma?

Research has shown that Temozolomide (TMZ) can extend survival and slow tumor growth in people with glioblastoma, a fast-growing brain cancer. Studies have found that longer treatment with TMZ can increase survival time and delay cancer progression. However, the cancer can sometimes become resistant, ceasing to respond to the treatment. Some research suggests that altering the administration of TMZ might yield better results than the standard approach. While TMZ shows promise, resistance remains a challenge, particularly for those with specific tumor characteristics.45678

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older with newly diagnosed glioblastoma (a type of brain cancer) that has an 'unmethylated MGMT' marker. Participants must have finished a specific course of radiation and chemo, be in reasonably good health, and have working major organs.

Inclusion Criteria

I am 65 years old or older.
I finished 3 weeks of radiation and TMZ treatment within the last 6 weeks.
My tumor has an unmethylated MGMT promoter.
See 5 more

Exclusion Criteria

My cancer has spread widely to the lining of my brain or spinal cord.
Known hypersensitivity to TMZ components or Dacarbazine
Inability to undergo contrast-enhanced magnetic resonance imaging (MRI)
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive three weeks of radiation therapy, alone or combined with chemotherapy using Temozolomide

3 weeks

Break

A break period following radiation therapy

4-6 weeks

Chemotherapy

Participants receive Temozolomide chemotherapy with a modified regimen

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Temozolomide

Trial Overview

The study tests daily Temozolomide (TMZ) chemotherapy given after radiation therapy using a modified schedule to see if it helps elderly patients whose tumors are less likely to respond to standard treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

Citations

Effects of temozolomide dosing on outcome in glioblastoma

No significant impact on survival outcomes was observed when distance from the calculated temozolomide dose was analyzed as a continuous ...

Temozolomide (TMZ) in the Treatment of Glioblastoma ... - PMC

Acquired resistance to TMZ seems to be the main reason for the short median survival of GBM patients, thus understanding the mechanisms ...

Combinatorial treatment of glioblastoma with ...

TMZ+EdU significantly improves antitumor efficacy compared to either single-agent therapy against GBM cell lines in vitro, against three ...

Prolonged Sequential Temozolomide in Glioblastoma

Across studies, prolonged TMZ was not associated with a clear survival advantage. Pooled median OS was 17.10 months for six cycles and 17.64 ...

Extended cycles of adjuvant temozolomide improves ...

This study indicated that prolonged adjuvant TMZ significantly enhanced OS and PFS in GBM, and the adverse events were acceptable.

Efficacy and safety of extended adjuvant temozolomide ... - PMC

There is low-certainty evidence that extended adjuvant TMZ is not associated with significant survival benefit or increased hematologic toxicity.

The impact of extended adjuvant temozolomide in newly ...

Several randomized and nonrandomized trials have demonstrated the efficacy and safety of TMZ for the treatment of GBM. In 2005, Stupp and colleagues ...

Efficacy and Safety of Prolonged Adjuvant Temozolomide ...

The pooled results showed no statistically significant improvement in survival with extended TMZ. Specifically, the hazard ratio for progression ...