OncoMatch/Clinical Trials/NCT07476794
Daily Temozolomide for Elderly Patients With Unmethylated MGMT- Promoter Newly Diagnosed GliOblatoma
Is NCT07476794 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Daily TMZ for glioblastoma.
Treatment: Daily TMZ — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: MGMT unmethylated promoter
Unmethylated MGMT promoter, according to local assessment
Required: IDH1 wild-type
IDH wild-type GBM
Disease stage
Required: Stage WHO GRADE 4 (WHO)
Grade: 4 (WHO)
WHO grade 4, IDH wild-type GBM
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: radiation therapy
Completed treatment with 40 Gy in 15 fractions over three weeks
Must have received: cytotoxic chemotherapy (temozolomide) — concurrent with radiation
with concurrent TMZ, within six weeks prior to enrollment
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >1.5 × 10⁹/L (1,500 cells/mm³). Platelet count >100 × 10⁹/L (100,000 cells/mm³).
Kidney function
Serum creatinine <1.5 times the upper limit of normal.
Liver function
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.
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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