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

ConditionGlioblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorSunnybrook Health Sciences Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Daily TMZ

    Drug

    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

Treatment groups

118 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

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