Glioblastoma
Conditions
Interventions
1) Concomitant phase,
metformin (level1 , everyday) 7days
2) Maintenance phase, metformin and temozolomide
temozolomide (150mg/m2, day1-5, every 4 weeks) and metformin (level3 , everyday) 1 cycle
tem
Sponsors
Narita Yoshitaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 = 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I:Dose limiting toxicity (DLT) occurrence rate,Phase II:12-month progression-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate, 12-month progression-free survival rate, 12-month survival rate, overall survival, response rate, adverse event occurrence rate, protocol treatment completion rate | — |
Contacts
Public ContactMakoto Ohno
National Cancer Center Hospital
Outcome results
None listed