BridgeMD
New treatment option for Glioblastoma
Official title Daily Temozolomide for Elderly Patients With Unmethylated MGMT- Promoter Newly Diagnosed GliOblatoma
ClinicalTrials.gov ID: NCT07476794
What this study is testing
What is Daily TMZ?
Daily TMZ is an investigational medicine, given as an once-daily, being studied as a potential treatment for glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Glioblastoma is an aggressive type of brain cancer. Standard treatment usually includes three weeks of radiation therapy alone or combined with chemotherapy using Temozolomide.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.