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Study on Metformin Plus Temozolomide in Patient With Recurrent Glioblastoma Multiforme

Study on Metformin Plus Temozolomide in Patient With Recurrent Glioblastoma Multiforme

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034140
Enrollment
Unknown
Registered
2020-06-26
Start date
2019-06-01
Completion date
Unknown
Last updated
2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Interventions

Case series:Metformin Plus Temozolomide

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Histologically confirmed GBM at first; (2) The patient has received STUPP standard treatment; (3) Recurrent glioblastoma conformed by histopathological or radiological diagnosis; (4) Aged 18 to 70 years; (5) Karnofsky score >=60; (6) Expected survival period is more than 3 months; (7) Normal in hematological finding, heart, liver, lung and kidney function; blood: white blood cell >3.0x10^9/L, platelet count >80x10^9/L, hemoglobin >11g/dl, liver function: serum bilirubin 1.5 ULN, alt and AST <2.5 ULN, blood creatinine <=1.5mg/dl; PT/PTT 1.5 ULN; (8) Signature of informed consent.

Exclusion criteria

Exclusion criteria: (1) History of type I or type II Diabetes; (2) Has contraindications for the use of metformin; (3) History of one of the following metabolic diseases: primary carnitine deficiency, type I or II carnitine transferase deficiency, beta oxidation deficiency, short chain acyl dehydrogenase deficiency, medium chain acyl dehydrogenase deficiency, long chain 3-hydroxyacyl Kievase A deficiency, medium chain acyl Kievase A deficiency, Pyruvateboxa deficiency, porphyrin deficiency; (4) With severe Dyslipidemia: total cholesterol >6.47 mmol/L, triglyceride >5.65 mmol/L; (5) Chemotherapy Intolerance; (6) Pregnant of breast feeding; (7) History of other malignancies; (8) History of Schizophrenia; (9) Can not perform MRI examination; (10) Past cancer-related toxicity did not return to baseline levels.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival;

Secondary

MeasureTime frame
Overall Survival;Quality Of Life;

Countries

China

Contacts

Public ContactZhenghe Chen

Sun Yat-sen University Cancer Center

chenzhengh@sysucc.org.cn+86 18218227082

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026