Phase 2 clinical trial for the 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
- Conditions
- Neoplasms
- Registration Number
- KCT0002632
- Brief Summary
Although metformin plus temozolomide regimen was well tolerated, it did not show any clinical benefit in patients with recurrent or refractory GBM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 81
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of progression-free survival obtained from progression-free survival curve
- Secondary Outcome Measures
Name Time Method Response Rate;Tumor control probability;6 month orogression free survival;6 month overall survival;Quality of life;Safety