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NCT07894549

A Single-Arm, Open-Label, Multicenter Clinical Study of Teniposide Combined With Temozolomide for the Treatment of Newly Diagnosed Glioblastoma (nGBM) With MGMT Promotor Region Unmethylated

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The Primary Objective of this study is to evaluate the efficacy and safety of teniposide in combination with temozolomide for the treatment of newly diagnosed glioblastoma (nGBM) with MGMT promotor region unmethylated. The study will also assess the safety of teniposide combined with temozolomide. The primary questions to be addressed include: * Does the treatment demonstrate efficacy for the disease under study? * What medical problems or adverse events may participants experience while receiving the study drugs? Participants will: * Receive teniposide: 60 mg/m² in 500 mL of normal saline, administered as an intravenous infusion over at least 30 minutes, once daily on Days 1-3 of each cycle. Each cycle is 28 days, for a total of 6 cycles.Receive temozolomide (TMZ) orally: 150 mg/m² once daily for 5 days during Cycle 1; starting from Cycle 2, the dose will be increased to 200 mg/m² once daily for 5 days. Each cycle is 28 days, for a total of 6 cycles. * Visit the hospital for assessments at each cycle. * Have their medication adherence and assessment results recorded.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10

Completion Date

2030-12

Last Updated

2026-10-26

Healthy Volunteers

Conditions

Newly Diagnosed Glioblastoma MGMT-Unmethylated Glioblastoma

Interventions

DRUG

Teniposide Combined with Temozolomide

Receive teniposide: 60 mg/m² in 500 mL of normal saline, administered as an intravenous infusion over at least 30 minutes, once daily on Days 1-3 of each cycle. Each cycle is 28 days, for a total of 6 cycles. Receive temozolomide (TMZ) orally: 150 mg/m² once daily for 5 days during Cycle 1; starting from Cycle 2, the dose will be increased to 200 mg/m² once daily for 5 days. Each cycle is 28 days, for a total of 6 cycles.

Inclusion Criteria: * 1\. Newly diagnosed with glioblastoma (nGBM), histopathologically confirmed according to the 2021 WHO Classification of Tumors of the Central Nervous System. 2\. Aged ≥18 years, regardless of gender. 3. Recovered from maximal cytoreductive surgery; patients with gross total resection, partial resection, or biopsy only are all acceptable. 4\. Previously received standard concurrent chemoradiotherapy with temozolomide (TMZ), having completed standard adjuvant radiotherapy of approximately 60 Gy (or biologically equivalent dose) with daily TMZ chemotherapy at 75 mg/m². 5\. About to enter the adjuvant TMZ maintenance therapy phase. 6. Confirmed MGMT promoter methylation-negative (MGMT-unmethylated) status, as determined by central laboratory analysis at each participating site. 7\. At least 4 weeks (≥28 days) have elapsed since the completion of radiotherapy prior to enrollment. 8\. Karnofsky Performance Status (KPS) score ≥70, and Eastern Cooperative Oncology Group (ECOG) performance sta Exclusion Criteria: * 1\. Early progressive disease following the completion of TMZ/RT (including patients with suspected pseudoprogression). 2\. Patients with a history of other malignancies (excluding those who have achieved complete remission from cancer and have not received any disease-related treatment for more than 3 years); patients who have previously received brain radiotherapy, chemotherapy, or immunotherapy; or patients who are currently undergoing or planning to undergo other anti-tumor therapies. 3\. Baseline MRI indicating a recent risk of intracranial hemorrhage or brain herniation. 4\. Unresolved toxicity reactions of CTCAE 5.0 grade ≥2 caused by any prior treatment, excluding alopecia. 5\. Inability to take oral medications or inability to swallow. 6. Presence of any severe and/or uncontrolled diseases, including: (1) Patients with poorly controlled blood pressure despite the use of one antihypertensive medication (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg); pat