A phase I/II study of maintenance therapy with metformin and temozolomide for newly diagnosed glioblastoma patients - MET Study

arita Yoshitaka0 个研究点目标入组 22 人开始时间: 2021年2月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Histologically proven Grade IV glioblastoma multiforme (GBM, WHO grade IV glioma)
•2) No history of previous therapy for tumor except resection or biopsy.
•3) Tumor without cerebellar/stem development confirmed by preoperative MRI.
•4) Head MRI before registration revealed no multiple legions or dissemination.
•5) Before registration, presence or absence of measurable lesion does not matter.
•6) Initial treatment : temozolomide for 30 days or longer with over 50 Gy radiation therapy.
•7) Within 49 days from the last irradiation day of the radiotherapy with temozolomide.
•8) Aged 20 to 75 years old at registration.
•9) KPS (Karnofsky performance status) >= 70
•10) No prior chemotherapy or radiation therapy for any malignant diseases, but endocrine therapy for breast cancer or prostatic cancer is acceptable.
•11) Adequate organ function. Sufficient organ function. The latest test value within 14 days of registration
•Neutrophil >= 1,500/mm3
•Hb >= 8.0 g /dL
•Platelet >= 10X104/mm3
•AST <= 150 IU/L
•ALT <= 150 IU/L
•Estimated g lomerular filtration rate (eGFR) >= 45mL/min/1.73m2(However, eGFR >= 60 mL/min/1.73m2 for patients scheduled to administer metformin 2250 mg /day)
•Fasting blood g lucose >= 73mg /dL
•HbA1c <= 6.2%
•12) Implantation of BCNU wafers during surgery is permitted.TTF tumor treating fields (NovoTTF-100A system) and photodynamic therapy using thalaporphine sodium is not permitted.
•13) Written informed consent.

•1) Synchronous(within 2 years) or metachronous (within 5 years) malignancy, except for carcinoma in situ or mucosal tumors curatively treated with local therapy
•2) Active infection requiring systemic therapy
•3) Active infectious meningitis
•4) Body temperature >= 38 degrees Celsius at registration
•5) Women during pregnancy, possible pregnancy, within 28 days after delivery, or breast-feeding
•6) Psychosis or with psychotic symptom
•7) Continuous systemic use of steroid or immunosuppressant for disease except for brain tumor
•8) History of lactic acidosis
•9) History of hypersensitivity to biguanide drugs
•10) Diabetes mellitus routine administration of insulin or hypoglycemic agent
•11) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 month
•12) Interstitial pneumonia, pulmonary fibrosis, or severe lung emphysema diagnosed with X-ray test
•13) Gadolinium allergy
•14) Positive HIV antibody
•15) Potitive HBs antigen
•16) Any other medical or psychiatric impairments that will prevent administration of protocol therapy in the investigator opinion

发起方

arita Yoshitaka