Trial | NCT03243851  Report issue

Title

Study on Low Dose Temozolomide Plus Metformin or Placebo in Patient With Recurrent or Refractory Glioblastoma
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    81
A 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
Studies will investigate the efficacy and safety of low dose Temozolomide with Metformin or placebo for the patients with recurrent or refractory Glioblastoma.

The dosage of the Metformin will follow the domestically permitted dose to minimize side effects.

The patients will be allocated randomly to arm 1(experimental) and arm 2(placebo controlled) and administered the investigational products for up to 6 cycle. Each cycle consists of 4 weeks.

After 6 cycle(24 weeks), the patients will be checked progression and survival every 24 weeks up to 96 weeks.
Study Started
Nov 21
2016
Primary Completion
Dec 31
2020
Study Completion
Dec 31
2020
Last Update
Sep 09
2021

Drug Temozolomide+Metformin [temozolomide (temodar), metformin (glucophage)]

Low dose temozolomide+metformin for 24 weeks

Drug Temozolomide+Placebo

Low dose temozolomide+placebo for 24 weeks

Temozolomide+metformin Experimental

Temozolomide : 1 cycle of 4 weeks with daily dose 50mg/m2(BSA: Body Surface Area) up to 6 cycles for 24 weeks Metformin : 1st cycle (4 weeks) 1 week(1st~7th day) = 1,000mg/day 1 week(8th~14th day) = 1,500mg/day 2 weeks(15th ~28th day) = 2,000mg/day 2nd to 6th cycle (20 weeks) = 2,000mg/day

Temozolomide+placebo Placebo Comparator

Temozolomide : 1 cycle of 4 weeks with daily dose 50mg/m2(BSA: Body Surface Area) up to 6 cycles for 24 weeks Placebo: 1st cycle (4 weeks) 1 week(1st~7th day) = 1,000mg/day 1 week(8th~14th day) = 1,500mg/day 2 weeks(15th~28th day) = 2,000mg/day 2nd to 6th cycle (20 weeks) = 2,000mg/day

Criteria 

Inclusion Criteria:

Progressive or recurrent Glioblastoma conformed by histopathological or radiological diagnosis. Progressive or recurrent Glioblastoma during or after standard therapy (Temozolomide after Temozolomide and radiation therapy; Stupp regimen) after histopathological diagnosis of Glioblastoma Recurrence or progression is diagnosed according to histopathological diagnosis or revised RANO(Response Assessment in Neuro-Oncology) criteria c
Karnofsky performance status(KPS) ≥ 60%
Age ≥ 19 years old
At least 4 weeks after operation or chemotherapy

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
Be informed of the nature of the study and obtained a written informed consent
A legal representative agrees to the trial when a subject is unable to communicate smoothly due to neurologic defect
If a fertile woman who has been confirmed negative to a urine or blood pregnancy test within 28 days prior to the trial

Exclusion Criteria:

Pregnant or breast feeding
Cancer history within 5 years excluding cancer in the skin cells and cervix
Active infections within two weeks
Leptomeningeal metastasis
Patients diagnosed with diabetes
Hypersensitive or intolerance to Metformin
Patients who are currently taking Metformin, sulfonylureas, thiazolidinediones, and insulin, regardless of reason

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
Those who have participated in other clinical trials may not recover from the toxicity of the treatment.
No Results Posted