Efficacy and safety of low dose Temozolomide plus metformin as combination chemotherapy compared with low dose Temozolomide plus placebo in patient with recurrent or refractory Glioblastoma : A randomized, prospective, multi-center, double-blind, controlled, phase? trial

The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 81 人开始时间: 待定最近更新: 2024年3月4日

适应症

试验速览

Although metformin plus temozolomide regimen was well tolerated, it did not show any clinical benefit in patients with recurrent or refractory GBM.

•1) Progressive or recurrent Glioblastoma conformed by histopathological or radiological diagnosis
•Progressive or recurrent Glioblastoma during or after standard therapy (Temozolomide after Temozomide and radiation therapy; Stupp regimen) after istopathological diagnosis of Glioblastoma
•Recurrence or progression is diagnosed according to histopathological diagnosis or revised RANO criteria
•2) Karnofsky performance status(KPS) = 60%
•3) Age = 19 years old
•4) At least 4 weeks after operation or chemotherapy
•5) Normal in hematological finding, liver and kidney function
•- Hematology
•ANC > 1.500/mm³, Platelet > 100,000/mm³, WBC > 3×10^9/L,
•Hemoglobin > 9g/dL
•- Liver function
•Total Bilirubin level = 1.5×ULN(in case of isolated hyperbilirubinemia =2.5 x ULN)
•AST / ALT < 2.5×ULN
•- Renal function
•Serum creatinine = 1.5mg/dL
•6) Be informed of the nature of the study and obtained a written informed consent
•7) A legal representative agrees to the trial when a subject is unable to communicate smoothly due to a neurologic defect
•8) If a fertile woman who has been confirmed negative to a urine or blood pregnancy test within 28 days prior to the trial

•1) Pregnant or breast feeding
•2) Cancer history within 5 years excluding cancer in the skin cells and cervix
•3) Active infections within the last two weeks
•4) Leptomeningeal metastasis
•5) Patients diagnosed with diabetes
•6) Hypersensitive or intolerance to Metformin
•7) Patients who are currently serving Metformin, sulfonylureas, thiazolidinediones, and insulin, regardless of reason
•8) Other serious diseases or medical conditions that include :
•- Patients who suffer from unstable heart disease despite treatment.
•- Patients having a heart attack within 6 months prior to the start of trial
•- Patients who suffer from severe nerve or psychosis that includes dementia or strokes.
•- Patients with an uncontrolled infection
•- Patient with uncontrolled hypertension, congestive heart failure, unstable angina, or incomplete arrhythmia
•9) Those who have participated in other clinical trials may not recover from the toxicity of the treatment.

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